Journal articles: 'Orodispersible film'

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Muhammad Naeem Aamir, Muhammad Naeem Aamir, Aneela Manzoor Aneela Manzoor, Hina Hussain Hina Hussain, Zeeshan Javaid Zeeshan Javaid, Tariq Mahmood Tariq Mahmood, Khizar Abbas Khizar Abbas, and and Akhtar Rasul and Akhtar Rasul. "Orodispersible Films of an Antipsychotic Drug: Development and Physicochemical Characterization." Journal of the chemical society of pakistan 41, no. 3 (2019): 469. http://dx.doi.org/10.52568/000750/jcsp/41.03.2019.

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To deliver maximum amount of paroxetine in shortest duration of time, the orodispersible films (ODF) were formulated and tested for their suitability as a carrier system. ODF were prepared by using hydroxypropyl methylcellulose and polyvinyl alcohol and different superdisintegrants at a specific proportion. The newly developed ODF were subjected to characterization for folding endurance, weight variations, thickness, disintegration time, drug release pattern and drug content. The surface morphology of orodispersible film was examined by means of scanning electron microscope. Moreover physical compatibility between the drug and excipients was guaranteed in the orodispersible film by Fourier transform infrared spectroscopy. It was found that all films prepared were transparent, smooth and elegant in appearance. ODF showed good folding endurance, uniform thickness, weight and drug content. The surface pH of all orodispersible film was found to be neutral and they disintegrate within few seconds. FTIR spectroscopy supported compatible among all excipients and they can be used together in formulation. It was concluded that stable paroxetine orodispersible films can be made by solvent casting technique with ultrafast dissolution rate.

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Manda, Prashanth, Carmen Popescu, Abhishek Juluri, Karthik Janga, Praneeth Rao Kakulamarri, Sushmitha Narishetty, S. Narasimha Murthy, and Michael A. Repka. "Micronized Zaleplon Delivery via Orodispersible Film and Orodispersible Tablets." AAPS PharmSciTech 19, no. 3 (January 19, 2018): 1358–66. http://dx.doi.org/10.1208/s12249-017-0924-9.

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Serrano, Dolores R., Raquel Fernandez-Garcia, Marta Mele, Anne Marie Healy, and Aikaterini Lalatsa. "Designing Fast-Dissolving Orodispersible Films of Amphotericin B for Oropharyngeal Candidiasis." Pharmaceutics 11, no. 8 (August 1, 2019): 369. http://dx.doi.org/10.3390/pharmaceutics11080369.

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Amphotericin B possesses high activity against Candida spp. with low risk of resistance. However, Amphotericin B’s high molecular weight compared to other antifungal drugs, such as miconazole and clotrimazole, and poor water solubility hampers its efficacy at the physiological conditions of the oropharyngeal cavity (saliva pH, limited volume for dissolution) and thereby limits its clinical use in oropharyngeal candidiasis. We have prepared fast-dissolving orodispersible films with high loading (1% w/w) using solvent casting that enables amphotericin B to remain solubilised in saliva in equilibrium between the monomeric and dimeric states, and able to produce a local antifungal effect. Optimisation of the amphotericin B-loaded orodispersible films was achieved by quality by design studies combining dextran and/or maltodextrin as dextrose-derived-polymer film formers with cellulose-derived film formers (hydroxypropylmethyl/hydroxypropyl cellulose in a 1:4 weight ratio), sorbitol for taste masking, microcrystalline cellulose (Avicel 200) or microcrystalline cellulose-carboxymethylcellulose sodium (Avicel CL-611) for enhancing the mechanical strength of the film, and polyethylene glycol 400 and glycerol (1:1 w/w) as plasticizers. The optimised amphotericin B orodispersible films (containing 1% AmB, 25% dextran, 25% maltodextrin, 5% sorbitol, 10% Avicel 200, 10% polyethylene glycol 400, 10% glycerol, 3% hydroxypropylmethyl cellulose acetate succinate, 12% hydroxypropyl cellulose) possessed a fast disintegration time (60 ± 3 s), quick release in artificial saliva (>80% in 10 min), high burst strength (2190 mN mm) and high efficacy against several Candida spp. (C. albicans, C. parapsilosis and C. krusei) (>15 mm inhibition halo). Amphotericin B orodispersible films are stable for two weeks at room temperature (25 °C) and up to 1 year in the fridge. Although further toxicological and in vivo efficacy studies are required, this novel Amphotericin B orodispersible films is a promising, physicochemically stable formulation with potential wide application in clinical practice, especially for immunocompromised patients suffering from oropharyngeal candidiasis.

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Olechno, Katarzyna, Anna Basa, and Katarzyna Winnicka. "“Success Depends on Your Backbone”—About the Use of Polymers as Essential Materials Forming Orodispersible Films." Materials 14, no. 17 (August 27, 2021): 4872. http://dx.doi.org/10.3390/ma14174872.

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Polymers constitute a group of materials having a wide-ranging impact on modern pharmaceutical technology. Polymeric components provide the foundation for the advancement of novel drug delivery platforms, inter alia orodispersible films. Orodispersible films are thin, polymeric scraps intended to dissolve quickly when put on the tongue, allowing them to be easily swallowed without the necessity of drinking water, thus eliminating the risk of choking, which is of great importance in the case of pediatric and geriatric patients. Polymers are essential excipients in designing orodispersible films, as they constitute the backbone of these drug dosage form. The type of polymer is of significant importance in obtaining the formulation of the desired quality. The polymers employed to produce orodispersible films must meet particular requirements due to their oral administration and have to provide adequate surface texture, film thickness, mechanical attributes, tensile and folding strength as well as relevant disintegration time and drug release to obtain the final product characterized by optimal pharmaceutical features. A variety of natural and synthetic polymers currently utilized in manufacturing of orodispersible films might be used alone or in a blend. The goal of the present manuscript was to present a review about polymers utilized in designing oral-dissolving films.

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Steiner, Denise, Jan Henrik Finke, and Arno Kwade. "SOFTs – Structured orodispersible film templates." European Journal of Pharmaceutics and Biopharmaceutics 137 (April 2019): 209–17. http://dx.doi.org/10.1016/j.ejpb.2019.03.001.

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Göbel, Anja, and Jörg Breitkreutz. "Concept of Orodispersible or Mucoadhesive “Tandem Films” and Their Pharmaceutical Realization." Pharmaceutics 14, no. 2 (January 22, 2022): 264. http://dx.doi.org/10.3390/pharmaceutics14020264.

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Orodispersible or mucoadhesive films as a patient-oriented dosage form for low-dosed drugs are usually produced using solvent casting. This paper presents a modification of the solvent casting technique that aimed to divide oral films into two or more compartments. The proposed objectives and fields of applications include improved handling properties and safety of application, the optimization of drug release kinetics and the enhancement of long-term stability when combining two or more active pharmaceutical ingredients into one oral film. A feasibility study for the combination of different film-forming polymers to generate the so-called tandem films was performed. As examples of practical implementation, orodispersible applicator films consisting of a drug-loaded section and a handheld piece were cast, and mucoadhesive buccal tandem films were cast to optimize the dissolution rate of the films.

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Islam, Nayyer, Muhammad Irfan, Salah-Ud-Din Khan, Haroon Khalid Syed, Muhammad Shahid Iqbal, Ikram Ullah Khan, Amina Mahdy, et al. "Poloxamer-188 and d-α-Tocopheryl Polyethylene Glycol Succinate (TPGS-1000) Mixed Micelles Integrated Orodispersible Sublingual Films to Improve Oral Bioavailability of Ebastine; In Vitro and In Vivo Characterization." Pharmaceutics 13, no. 1 (January 4, 2021): 54. http://dx.doi.org/10.3390/pharmaceutics13010054.

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Orodispersible sublingual films (OSFs) composed of hydrophilic polymers were loaded with poloxamer-188 and d-α-tocopheryl polyethylene glycol succinate (TPGS-1000) mixed micelles to improve the oral bioavailability of a poorly soluble drug, ebastine (EBT). Mixed micelles formed by thin-film hydration method were incorporated into orodispersible sublingual film, consisting of HPMC and glycerol, using solvent casting technique. The mixed micelles and films were thoroughly evaluated for physicochemical characterization (size, polydispersity index, zeta potential, entrapment efficiency, thickness, weight, surface pH studies, disintegration time, swelling indices, mechanical properties, FTIR, PXRD, DSC, SEM, AFM, in vitro drug release, in vivo bioavailability, and toxicological studies). The results showed that the average particle size of mixed micelles was 73 nm. The mean zeta potential and PDI of the optimal mixed micelles formulation were −26 mV and 0.16, respectively. Furthermore, the maximum entrapment efficiency 82% was attained. The film’s disintegration time was in the range of 28 to 102 s in aqueous media. The integrity of micelles was not affected upon incorporation in films. Importantly, the micelles-loaded films revealed rapid absorption, high permeability, and increased bioavailability of EBT as compared to the pure drug. The existence of ebastine loaded mixed micelles in the films enhanced the bioavailability about 2.18 folds as compared to pure drug. Further, the results evidently established in-vitro and in-vivo performance of bioavailability enhancement, biocompatibility, and good safety profile of micelles-loaded orodispersible EBT films. Finally, it was concluded that film loaded with poloxamer-188/TPGS-1000 mixed micelles could be an effective carrier system for enhancing the bioavailability of ebastine.

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Huanbutta, Kampanart, Pornsak Sriamornsak, Inderbir Singh, and Tanikan Sangnim. "Manufacture of 2D-Printed Precision Drug-Loaded Orodispersible Film Prepared from Tamarind Seed Gum Substrate." Applied Sciences 11, no. 13 (June 24, 2021): 5852. http://dx.doi.org/10.3390/app11135852.

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Two-dimensional (2D) printing is a simple technology that shows the possibility for the preparation of personalized pharmaceutical dosage forms. This technology can accurately print medicine in different sizes, which can be applied to develop a personalized, drug-loaded orodispersible film for patients with dysphagia. Seed gum from Tamarindus indica Linn was selected as the film former of the printing substrate, and sorbitol was applied as a film plasticizer. Theophylline was used as a printed model drug due to its narrow therapeutic index. From the results, the mechanical properties of the film indicated that increasing the level of sorbitol improved the flexibility and strength of the film, which rendered the gum film suitable as a printing substrate. Conversely, raising portions of the gum (more than 3.5%) led to the use of rigid and stress-resistant films that can crack during the printing process. The Fourier transform infrared result revealed that there was no interaction between theophylline and the gum after the printing process. The printed theophylline was mainly in an amorphous form based on the X-ray diffraction results. Furthermore, theophylline was deposited at the surface of the gum substrate after the drug-printing process, as depicted in the scanning electron microscope images. The printed drug on the orodispersible film can be accurately determined by varying the printing size/repeat. Lastly, the drug was completely released from the orodispersible film within 5 min. The research results showed the possibility of utilizing tamarind seed gum as a potential printing substrate for the 2D drug-printing technique. Moreover, this can be applied as an electronic prescribing system for telemedicine in the future.

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Janigová, Natália, Jan Elbl, Sylvie Pavloková, and Jan Gajdziok. "Effects of Various Drying Times on the Properties of 3D Printed Orodispersible Films." Pharmaceutics 14, no. 2 (January 21, 2022): 250. http://dx.doi.org/10.3390/pharmaceutics14020250.

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Orodispersible films are an innovative dosage form. Their main advantages are the application comfort and the possibility of personalization. This work aimed to evaluate the influence of different drying times on the properties of orodispersible films of various thicknesses, prepared in two different semisolid extrusion 3D printing setups. In the first experiment, drying times were dependent on the overall print time of each batch. In the second setup, the drying time was set equal according to the longest one. The evaluated parameters were films’ weight uniformity, thickness, moisture content, surface pH, disintegration time, hardness, and tensile strength. Upon statistical comparison, significant differences in the moisture content were found, subsequently affecting the disintegration time. Moreover, statistically significant differences in films’ mechanical properties (hardness, tensile strength) were also described, proving that moisture content simultaneously affects film plasticity and related properties. In conclusion, a mutual comparison of the manufactured orodispersible films showed that the drying time affects their physical and mechanical properties. The in-process drying setup was proved to be sufficient while allowing quicker manufacturing.

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Wadher, Kamlesh J., Charvi J. Kubde, Swati D. Malkote, Manasi S. Thakre, Chetna J. Shelote, and Milind J. Umekar. "Formulation and Characterization of Montelukast Sodium Mouth Dissolving Film Using Cress Seed Mucilage." Journal of Drug Delivery and Therapeutics 13, no. 2 (February 15, 2023): 16–20. http://dx.doi.org/10.22270/jddt.v13i2.5891.

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There is a rising interest in the development of orodispersible films (ODFs) as an alternative to fast dissolving tablets which is attributed to their faster dissolution rate, higher durability, and better patient compliance. Owing to its rheological and also various functional properties, many researchers tried to discover some of the pharmaceutical applications of L. sativum in the development of various dosage forms, in addition to its therapeutic studies, such as binding, dissolving, gelling and sustained release dosage form. The fast-dissolving oral film of the Montelukast sodium by using Cress seed mucilage (CSM) and HPMC (15cps) is prepared by solvent casting method. The fast-dissolving oral film evaluated for folding endurance, surface pH, in-vitro disintegration time, drug content and in-vitro drug release. The physical appearance and folding endurance properties were found to be reasonably good and electron microscopy shows that films are clear, colorless with smooth surface.The drug content of all the films was in the range suggesting that drug was uniformly dispersed throughout all films. The present study was an attempt to develop and evaluate an oral fast dissolving drug delivery system using cress seed mucilage as a film former. Keywords: Orodispersible film, Montelukast sodium, Cress seed mucilage, HPMC

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Gupta, Suresh, Tegginamath Pramod Kumar, and Devegowda Vishakante Gowda. "Patent Perspective on Orodispersible Films." Recent Patents on Drug Delivery & Formulation 14, no. 2 (November 26, 2020): 88–97. http://dx.doi.org/10.2174/1872211314666200904104022.

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: The traditional oral dosage forms (tablets, capsules, syrups, and elixirs) suffer from various disadvantages. They are pretty challenging to administer to patients with dysphagia, mucositis, and vomiting tendency. Therefore, gaining patient compliance using conventional dosage forms is highly cumbersome. One of the most transformative and innovative approaches to overcome such challenges is Orodispersible Films, a Novel Drug Delivery System. They are easy to consume, no need to chew or swallow and they do not even require water for consumption. Therefore, several drugs have been converted into orodispersible films to gain patient compliance. With the advent of these film formulations, new innovations are erupting and accordingly, companies in India are actively protecting them by filing ordinary patent applications in India and internationally under the Patent Cooperation Treaty. Patenting in India poses unique patentability challenges when compared with rest of the world. Nonetheless, meeting all the challenges and obtaining a valid patent not only help in recouping the cost involved in developing new drugs and its novel drug delivery systems but also helps in taking legal action against alleged infringers. This review article identifies key active Indian players in the domain of ODF based on their patent filings in India (and abroad) and also identifies the challenges they face to obtain a grant.

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Steiner, Denise, Jakob F. Emmendörffer, and Heike Bunjes. "Orodispersible Films: A Delivery Platform for Solid Lipid Nanoparticles?" Pharmaceutics 13, no. 12 (December 15, 2021): 2162. http://dx.doi.org/10.3390/pharmaceutics13122162.

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To overcome the poor bioavailability observed for many newly developed active pharmaceutical ingredients (APIs), an appropriate formulation strategy is necessary. One approach is the formulation of these substances in solid lipid nanoparticles and their further processing into solid dosage forms. A promising and innovative oral delivery platform could be orodispersible films (ODFs). ODFs were already investigated more closely, e.g., for the administration of API nanoparticles, and proved their suitability for this formulation approach. The current study was aimed at investigating if the HPMC (hydroxypropyl methyl cellulose) film matrix is also suitable to serve as an appropriate delivery platform for solid lipid nanoparticles. Dependent on the type of triglyceride nanoparticles embedded in the film matrix and the formulation of the lipid particles, lipid contents of up to 54 wt.% could be realized in the film matrix without the loss of the nanoparticulate state. Good mechanical properties were confirmed for these films by determining the tensile strength as well as the elongation before breakage. Interestingly, processing of a lipid suspension into this solid dosage form led to a significantly reduced transformation of the lipid particles from the metastable α- into the stable β-polymorph. This could prove very beneficial when the lipid particles are loaded with APIs.

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Lee, Ju-Hyun, Chulhun Park, In-OK Song, Beom-Jin Lee, Chin-Yang Kang, and Jun-Bom Park. "Investigation of Patient-Centric 3D-Printed Orodispersible Films Containing Amorphous Aripiprazole." Pharmaceuticals 15, no. 7 (July 19, 2022): 895. http://dx.doi.org/10.3390/ph15070895.

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The objective of this study was to design and evaluate an orodispersible film (ODF) composed of aripiprazole (ARP), prepared using a conventional solvent casting technique, and to fuse a three-dimensional (3D) printing technique with a hot-melt extrusion (HME) filament. Klucel® LF (hydroxypropyl cellulose, HPC) and PE-05JPS® (polyvinyl alcohol, PVA) were used as backbone polymers for 3D printing and solvent casting. HPC-, PVA-, and ARP-loaded filaments were applied for 3D printing using HME. The physicochemical and mechanical properties of the 3D printing filaments and films were optimized based on the composition of the polymers and the processing parameters. The crystalline states of drug and drug-loaded formulations were investigated using differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD). The dissolution and disintegration of the 3D-printed films were faster than those of solvent-cast films. HPC-3D printed film was fully disintegrated within 45 ± 3.5 s. The dissolution rate of HPC films reached 80% within 30 min at pH 1.2 and pH 4.0 USP buffer. There was a difference in the dissolution rate of about 5 to 10% compared to PVA films at the same sampling time. The root mean square of the roughness (Rq) values of each sample were evaluated using atomic force microscopy. The higher the Rq value, the rougher the surface, and the larger the surface area, the more salivary fluid penetrated the film, resulting in faster drug release and disintegration. Specifically, The HPC 3D-printed film showed the highest Rq value (102.868 nm) and average surface roughness (85.007 nm). The puncture strength of 3D-printed films had desirable strength with HPC (0.65 ± 0.27 N/mm2) and PVA (0.93 ± 0.15 N/mm2) to prevent deformation compared to those of marketed film products (over 0.34 N/mm2). In conclusion, combining polymer selection and 3D printing technology could innovatively design ODFs composed of ARP to solve the unmet medical needs of psychiatric patients.

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Matawo, Nyaradzo, Oluwatoyin A. Adeleke, and James Wesley-Smith. "Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy." International Journal of Molecular Sciences 21, no. 16 (August 10, 2020): 5714. http://dx.doi.org/10.3390/ijms21165714.

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The severity of tuberculosis (TB) in children is considered a global crisis compounded by the scarcity of pharmaceutical formulations suitable for pediatric use. The purpose of this study was to optimally develop and evaluate a pyrazinamide containing edible orodispersible film formulation potentially suitable for use in pediatrics actively infected with TB. The formulation was prepared employing aqueous-particulate blending and solvent casting methods facilitated by a high performance Box Behnken experimental design template. The optimized orodispersible formulation was mechanically robust, flexible, easy to handle, exhibited rapid disintegration with initial matrix collapse occurring under 60 s (0.58 ± 0.05 min ≡ 34.98 ± 3.00 s) and pyrazinamide release was controlled by anomalous diffusion coupled with matrix disintegration and erosion mechanisms. It was microporous in nature, light weight (57.5 ± 0.5 mg) with an average diameter of 10.5 mm and uniformly distributed pyrazinamide load of 101.13 ± 2.03 %w/w. The formulation was physicochemically stable with no evidence of destructive drug–excipient interactions founded on outcomes of characterization and environmental stability investigations. Preliminary inquiries revealed that the orodispersible formulation was cytobiocompatible, palatable and remained intact under specific storage conditions. Summarily, an edible pyrazinamide containing orodispersible film formulation was optimally designed to potentially improve TB pharmacotherapy in children, particularly the under 5 year olds.

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Reddy, Keshireddy Anji, and S. Karpagam. "Cellulose Orodispersible Films of Donepezil: Film Characterization and Drug Release." Pharmaceutical Chemistry Journal 51, no. 8 (November 2017): 707–15. http://dx.doi.org/10.1007/s11094-017-1679-z.

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Kittipongpatana, Ornanong S., Karnkamol Trisopon, Phanphen Wattanaarsakit, and Nisit Kittipongpatana. "Fabrication and Characterization of Orodispersible Composite Film from Hydroxypropylmethyl Cellulose-Crosslinked Carboxymethyl Rice Starch." Membranes 12, no. 6 (June 4, 2022): 594. http://dx.doi.org/10.3390/membranes12060594.

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Crosslinked carboxymethyl rice starch (CLCMRS), prepared via dual modifications of native rice starch (NRS) with chloroacetic acid and sodium trimetaphosphate, was employed to facilitate the disintegration of hydroxypropylmethylcellulose (HPMC) orodispersible films (ODFs), with or without the addition of glycerol. Fabricated by using the solvent casting method, the composite films, with the HPMC--LCMRS ratios of 9:1, 7:1, 5:1 and 4:1, were then subjected to physicochemical and mechanical evaluations, including weight, thickness, moisture content and moisture absorption, swelling index, transparency, folding endurance, scanning electron microscopy, Fourier transform infrared spectroscopy, tensile strength, elongation at break, and Young’s modulus, as well as the determination of disintegration time by using the Petri dish method (PDM) and slide frame and bead method (SFM). The results showed that HPMC-CLCMRS composite films exhibited good film integrity, uniformity, and transparency with up to 20% CLCMRS incorporation (4:1 ratio). Non-plasticized composite films showed no significant changes in the average weight, thickness, density, folding endurance (96–122), tensile strength (2.01–2.13 MPa) and Young’s modulus (10.28–11.59 MPa) compared to HPMC film (135, 2.24 MPa, 10.67 MPa, respectively). On the other hand, the moisture content and moisture absorption were slightly higher, whereas the elongation at break (EAB; 4.31–5.09%) and the transparency (4.73–6.18) were slightly lowered from that of the HPMC film (6.03% and 7.03%, respectively). With the addition of glycerol as a plasticizer, the average weight and film thickness increased, and the density decreased. The folding endurance was improved (to >300), while the transparency remained in the acceptable range. Although the tensile strength of most composite films decreased (0.66–1.75 MPa), they all exhibited improved flexibility (EAB 7.27–11.07%) while retaining structural integrity. The disintegration times of most composite films (PDM 109–331, SFM 70–214 s) were lower than those of HPMC film (PDM 345, SFM 229 s). In conclusion, the incorporation of CLCMRS significantly improved the disintegration time of the composite films whereas it did not affect or only slightly affected the physicochemical and mechanical characteristics of the films. The 5:1 and 4:1 HPMC:CLCMRS composite films, in particular, showed promising potential application as a film base for the manufacturing of orodispersible film dosage forms.

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Cupone, Irma Elisa, Eleonora Dellera, Fabio Marra, and Andrea Maria Giori. "Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation." Molecules 25, no. 24 (December 11, 2020): 5851. http://dx.doi.org/10.3390/molecules25245851.

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Vitamin D plays a crucial and very well-known role in regulation of calcium homeostasis and bone metabolism and mineralization. However, a huge and more recent body of evidence supports the positive influence of vitamin D on the regulation of immune response, ranging from protection against respiratory tract infections to prevention and management of asthma. Nevertheless, vitamin D deficiency is a very common condition and there is an increasing need for suitable products for proper supplementation, allowing good compliance also in specific populations. Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements. This study describes a 2000 IU Vitamin D3 ODF for daily intake, consisting of hydrophilic polymers and suitable excipients, manufactured by film-casting process. Elongation-at-break (E%), Young’s modulus (Y), and tensile strength (TS) were investigated using a dynamometer. Chemical stability was evaluated assaying the vitamin D3 in the films stored at different environmental conditions. In addition, in vitro disintegration and dissolution studies were performed. Correlation existed between the mechanical properties of the film and the residual water, acting as plasticizer. The stability study showed that vitamin D3 assay was ≥90% also after 3 months at 40 °C. The film disintegrated in less than 1 min and the vitamin D3 released was ≥75% after 15 min. An ODF with suitable properties can be manufactured and used as innovative dosage form for vitamin D3 food supplements.

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El-Setouhy, Doaa Ahmed, and Nevine Shawky Abd El-Malak. "Formulation of a Novel Tianeptine Sodium Orodispersible Film." AAPS PharmSciTech 11, no. 3 (June 8, 2010): 1018–25. http://dx.doi.org/10.1208/s12249-010-9464-2.

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ElMeshad, Aliaa N., and Arwa S. El Hagrasy. "Characterization and Optimization of Orodispersible Mosapride Film Formulations." AAPS PharmSciTech 12, no. 4 (October 19, 2011): 1384–92. http://dx.doi.org/10.1208/s12249-011-9713-z.

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Gupta, Maram Suresh, Tegginamath Pramod Kumar, and Devegowda Vishakante Gowda. "Orodispersible Thin Film: A new patient-centered innovation." Journal of Drug Delivery Science and Technology 59 (October 2020): 101843. http://dx.doi.org/10.1016/j.jddst.2020.101843.

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Turković, Erna, Ivana Vasiljević, Milica Drašković, Nataša Obradović, Dragana Vasiljević, and Jelena Parojčić. "An Investigation into Mechanical Properties and Printability of Potential Substrates for Inkjet Printing of Orodispersible Films." Pharmaceutics 13, no. 4 (March 30, 2021): 468. http://dx.doi.org/10.3390/pharmaceutics13040468.

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Inkjet printing is novel approach in drug manufacturing that enables dispensing precise volumes of ink onto substrates. Optimal substrate properties including suitable mechanical characteristic are recognized as crucial to achieve desired dosage form performance upon administration. Identification of relevant quality attributes and their quantification is subject of intensive scientific research. The aim of this work was to explore applicability of different materials as printing substrates and explore contribution of the investigated substrate properties to its printability. Substrates were characterized with regards to uniformity, porosity, disintegration time, mechanical properties and drug dissolution. Experimentally obtained values were mathematically transformed and the obtained results were presented as relevant radar charts. It was shown that structurally different substrates may be employed for orodispersible films inkjet printing. Main disadvantage of single-polymer films was low drug load, and their printability was dependent on film flexibility and mechanical strength. Structured orodispersible film templates exhibited favorable mechanical properties and drug load capacity. Wafer edible sheets were characterized with high mechanical resistance and brittleness which somewhat diminished printability, but did not hinder high drug load. Obtained results provide insight into application of different materials as printing substrates and contribute to understanding of substrate properties which can affect printability.

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Salawi, Ahmad. "An Insight into Preparatory Methods and Characterization of Orodispersible Film—A Review." Pharmaceuticals 15, no. 7 (July 9, 2022): 844. http://dx.doi.org/10.3390/ph15070844.

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Over the past few decades, researchers and companies have been trying to develop novel drug delivery systems to ensure safety, efficacy, compliance, and patient acceptability. Nowadays drug discovery and development are expensive, complex, and time-consuming processes, but trends are moving toward novel drug delivery systems. This delivery system helps to achieve drug response by local and systemic action through different routes. This novel approach of preparing orodispersible films (ODFs) provides benefits to paediatric, geriatric, and bedridden patients. This review paper aims to provide details on the preparation, characterization, and evaluation of ODFs; it also aims to focus on the positive and negative factors that affect film formulation and give an insight into potential drug candidates and polymers for use in ODFs. ODFs are effective, safe, and have good bioavailability as compared to fast-disintegrating tablets. The novel approach has various advantages because it provides instant effects in emergency situations and in schizophrenic and dysphasic patients without the need for taking water, the films disintegrating within a few seconds in the oral cavity. The solvent casting method is the most frequently used technique to develop ODFs, using film-forming polymers, which have a fast disintegration time, improved drug dissolution, and better drug contents.

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Steiner, Denise, Marius Tidau, and Jan Henrik Finke. "Embedding of Poorly Water-Soluble Drugs in Orodispersible Films—Comparison of Five Formulation Strategies." Pharmaceutics 15, no. 1 (December 21, 2022): 17. http://dx.doi.org/10.3390/pharmaceutics15010017.

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The poor bioavailability of many newly developed active pharmaceutical ingredients (APIs) poses a major challenge in formulation development. To overcome this issue, strategies such as the preparation of amorphous solid dispersions (ASDs), and the application of the APIs in lipid nanocarriers or the wet-milling of the substances into nanoparticles have been introduced. In addition to an efficient formulation strategy, a dosage form that is accepted by all patients is also of great importance. To enable a simple application of the oral dosage form for all patients, orodispersible films (ODFs) are a very promising delivery platform for the APIs because the films directly disintegrate in the mouth. In this study, two poorly water-soluble APIs, fenofibrate and naproxen, were formulated using five different formulation strategies and then embedded in ODFs. It was found that the deliverable amount of API with one ODF highly depends on the formulation strategy as well as the physicochemical properties of the formulated API. The most promising film formulations were ASD-ODFs as well as films with API-loaded lipid nanoemulsions. Both showed a reduction of the dissolution time of the APIs from the ODF compared to an ODF with unformulated API micro particles. In addition, short disintegration times were achieved, although the mechanical film properties were slightly worse compared to the API-free film formulation.

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Musazzi, Umberto M., Francesca Selmin, Silvia Franzé, Chiara G. M. Gennari, Paolo Rocco, Paola Minghetti, and Francesco Cilurzo. "Poly(methyl methacrylate) salt as film forming material to design orodispersible films." European Journal of Pharmaceutical Sciences 115 (March 2018): 37–42. http://dx.doi.org/10.1016/j.ejps.2018.01.019.

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Khan, Qurrat-ul-ain, Muhammad Irfan Siddique, Fatima Rasool, Muhammad Naeem, Muhammad Usman, and Muhammad Zaman. "Development and characterization of orodispersible film containing cefixime trihydrate." Drug Development and Industrial Pharmacy 46, no. 12 (November 6, 2020): 2070–80. http://dx.doi.org/10.1080/03639045.2020.1843477.

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Shinde, Swapnila Vivek, Shraddha Phatak, Ganesh Awale, and Supriya Nikam. "Development of Taste Masked Orodispersible Film Containing Paroxetine Hydrocloride." Indian Journal of Pharmaceutical Education and Research 54, no. 2s (May 29, 2020): s98—s107. http://dx.doi.org/10.5530/ijper.54.2s.66.

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Tian, Yu, Yoshita C. Bhide, Herman J. Woerdenbag, Anke L. W. Huckriede, Henderik W. Frijlink, Wouter L. J. Hinrichs, and J. Carolina Visser. "Development of an Orodispersible Film Containing Stabilized Influenza Vaccine." Pharmaceutics 12, no. 3 (March 8, 2020): 245. http://dx.doi.org/10.3390/pharmaceutics12030245.

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Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars such as trehalose and pullulan can be employed as stabilizing excipients for the antigens. In this study, first, β-galactosidase was used as a model antigen. Solutions containing β-galactosidase and sugar (trehalose or trehalose/pullulan blends) were pipetted onto plain ODFs and then either air- or vacuum-dried. Subsequently, sugar ratios yielding the highest β-galactosidase stability were used to prepare ODFs containing H5N1 whole inactivated influenza virus vaccine (WIV). The stability of the H5N1 hemagglutinin was assessed by measuring its hemagglutination activity. Overall, various compositions of trehalose and pullulan successfully stabilized β-galactosidase and WIV in ODFs. WIV incorporated in ODFs showed excellent stability even at challenging storage conditions (60 °C/0% relative humidity or 30 °C/56% relative humidity) for 4 weeks. Except for sugars, the polymeric component of ODFs, i.e., hypromellose, possibly improved stability of WIV as well. In conclusion, ODFs may be suitable for delivering of WIV to the oral cavity and can possibly serve as an alternative for injections.

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Preis, Maren, Miriam Pein, and Jörg Breitkreutz. "Development of a Taste-Masked Orodispersible Film Containing Dimenhydrinate." Pharmaceutics 4, no. 4 (October 26, 2012): 551–62. http://dx.doi.org/10.3390/pharmaceutics4040551.

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Olechno, Katarzyna, Bartosz Maciejewski, Klaudia Głowacz, Joanna Lenik, Patrycja Ciosek-Skibińska, Anna Basa, and Katarzyna Winnicka. "Orodispersible Films with Rupatadine Fumarate Enclosed in Ethylcellulose Microparticles as Drug Delivery Platform with Taste-Masking Effect." Materials 15, no. 6 (March 14, 2022): 2126. http://dx.doi.org/10.3390/ma15062126.

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Orally disintegrating (orodispersible) films provide a versatile tool for drug administration, especially in the pediatric and geriatric population, since they reduce the risk of choking and do not necessitate drinking water during application. By considering their direct contact with the taste buds, palatability is an influential aspect related to patient compliance. The microparticles based on taste-masking polymers containing drugs enclosed inside effectively mask the unpleasant taste of medicines. Ethylcellulose is a hydrophobic polymer widely used as a taste-masking material. Rupatadine fumarate, a second-generation antihistamine drug, is characterised by an intense bitter taste; therefore, it is crucial to achieve a tolerable taste whilst developing orodispersible formulations with its content. The objective of this study was to develop orally disintegrating films with rupatadine fumarate in the form of ethylcellulose-based microparticles obtained from aqueous dispersions of ethylcellulose—Surelease® or Aquacoat® ECD. It was a technological challenge to achieve homogenous drug content per dosage unit and sufficient mechanical properties for film operating due to the necessity to suspend the microparticles in the casting solution. Although the process of obtaining films consisted of several steps (mixing, pouring, drying), the particles were homogeneously dispersed, and each film of the desired size contained the proper dose of the drug. The taste-masking effect was also maintained. This parameter was confirmed by three independent methods: in vivo by healthy volunteers, an electronic tongue and a dissolution test. The applied taste-evaluation techniques showed that the films containing Aquacoat® ECD microparticles have the highest degree of bitter taste reduction, which confirms the results obtained in our previous studies.

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Chachlioutaki, Konstantina, Emmanouil K. Tzimtzimis, Dimitrios Tzetzis, Ming-Wei Chang, Zeeshan Ahmad, Christina Karavasili, and Dimitrios G. Fatouros. "Electrospun Orodispersible Films of Isoniazid for Pediatric Tuberculosis Treatment." Pharmaceutics 12, no. 5 (May 21, 2020): 470. http://dx.doi.org/10.3390/pharmaceutics12050470.

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Child-appropriate dosage forms are critical in promoting adherence and effective pharmacotherapy in pediatric patients, especially those undergoing long-term treatment in low-resource settings. The present study aimed to develop orodispersible films (ODFs) for isoniazid administration to children exposed to tuberculosis. The ODFs were produced from the aqueous solutions of natural and semi-synthetic polymer blends using electrospinning. The spinning solutions and the resulting fibers were physicochemically characterized, and the disintegration time and isoniazid release from the ODFs were assessed in simulated salivary fluid. The ODFs comprised of nanofibers with adequate thermal stability and possible drug amorphization. Film disintegration occurred instantly upon contact with simulated salivary fluid within less than 15 s, and isoniazid release from the ODFs in the same medium followed after the disintegration profiles, achieving rapid and total drug release within less than 60 s. The ease of administration and favorable drug loading and release properties of the ODFs may provide a dosage form able to facilitate proper adherence to treatment within the pediatric patient population.

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Cupone, Irma E., Andrea Sansone, Fabio Marra, Andrea M. Giori, and Emmanuele A. Jannini. "Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications." Pharmaceutics 14, no. 10 (September 22, 2022): 2011. http://dx.doi.org/10.3390/pharmaceutics14102011.

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Orodispersible film (ODF) is a new dosage form that disperses rapidly in the mouth without water or swallowing. The main ingredient of an ODF is a polymer that can be both of natural or synthetic origin. Maltodextrin is a natural polymer, mainly used in pharmaceutical and nutraceutical fields. This review aims to examine the literature regarding ODFs based on maltodextrin as the platform for developing new products for therapeutical application. ODFs based on maltodextrin contain plasticizers that enhance their flexibility and reduce their brittleness. Surfactants; fillers, such as homopolymer and copolymer of vinylacetate; flavour and sweetener were introduced to improve ODF characteristics. Both water-soluble and insoluble APIs were introduced up to 100 mg per dosage unit. The solvent casting method and hot-melt extrusion are the most useful techniques for preparing ODFs. In particular, the solvent casting method allows manufacturing processes to be developed from a lab scale to an industrial scale. ODFs based on maltodextrin are characterized in terms of mechanical properties, dissolution rate, taste and stability. ODFs made of maltodextrin, developed by IBSA, were tested in vivo to evaluate their bioequivalence and efficacy and were demonstrated to be a valid alternative to the marketed oral dosage forms.

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Ahmed El-Setouhy, Doaa, and Nevine Shawky Abd El-Malak. "Erratum to: Formulation of a Novel Tianeptine Sodium Orodispersible Film." AAPS PharmSciTech 11, no. 4 (October 7, 2010): 1499. http://dx.doi.org/10.1208/s12249-010-9524-7.

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Thabet, Yasmin, Dominique Lunter, and Joerg Breitkreutz. "Continuous inkjet printing of enalapril maleate onto orodispersible film formulations." International Journal of Pharmaceutics 546, no. 1-2 (July 2018): 180–87. http://dx.doi.org/10.1016/j.ijpharm.2018.04.064.

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Khadra, Ibrahim, Mohammad A. Obeid, Claire Dunn, Stewart Watts, Gavin Halbert, Steve Ford, and Alexander Mullen. "Characterisation and optimisation of diclofenac sodium orodispersible thin film formulation." International Journal of Pharmaceutics 561 (April 2019): 43–46. http://dx.doi.org/10.1016/j.ijpharm.2019.01.064.

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Shen, Bao-de, Cheng-ying Shen, Xu-dong Yuan, Jin-xia Bai, Qing-yuan Lv, He Xu, Ling Dai, Chao Yu, Jin Han, and Hai-long Yuan. "Development and characterization of an orodispersible film containing drug nanoparticles." European Journal of Pharmaceutics and Biopharmaceutics 85, no. 3 (November 2013): 1348–56. http://dx.doi.org/10.1016/j.ejpb.2013.09.019.

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GÜNEŞ, Meliha, Gökçe TURAN, Armağan DÖNMEZER, Fadime AYDIN KÖSE, Kevser Özgen ÖZER, and Sinem Yaprak KARAVANA. "MUCOADHESIVE ORODISPERSIBLE FILM FORMULATIONS OF RASAGILINE MESYLATE FOR PARKINSON TREATMENT." Ankara Universitesi Eczacilik Fakultesi Dergisi 47, no. 1 (November 21, 2022): 2. http://dx.doi.org/10.33483/jfpau.1150792.

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Amaç: Bu makale, Parkinson Hastalığının oral olmayan tedavisi için Rasagilin mesilat (RM) ağızda dağılan filmlerin (ODF'ler) formülasyon çalışmalarını ve in vitro değerlendirmesini içermektedir. RM, özellikle yoğun hepatik biyotransformasyona uğrayan geri döndürülemez ve yüksek seçiciliğe sahip bir MAO-B inhibitörüdür. Karaciğerde metabolize edilir ve oral biyoyararlanımı yaklaşık %36 ve yarılanma ömrü 3 saattir. Bu özellikler, RM'nin bukkal ilaç dağıtımı için mükemmel bir aday olabileceğini göstermektedir. Yöntem: RM'nin ODF'leri, solvent döküm yöntemiyle PEO kullanılarak hazırlandı. Bu formülasyonlar değerlendirilirken görünüş, ağırlık homojenliği, kalınlık, yüzey pH’ı, ilaç içeriği, şişme oranı, gerilme mukavemeti, mukoadezyon, in vitro ilaç salım çalışmaları ve stabilite gibi parametreler göz önünde bulundurulmuştur. Sonuç ve Tartışma: Elde edilen sonuçlar, ODF'lerin RM uygulaması için etkili ve uygulanabilir bir yaklaşım olduğunu ve Parkinson tedavisi için mevcut oral dağıtım sistemlerine yeni bir alternatif olabileceğini göstermektedir. Anahtar Kelimeler: Ağızda dağılan film, bukkal uygulama, polietilen oksit, rasaJilin mesilat

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Gupta, Ashutosh, Jatin Kumar, Surajpal Verma, and Harmanpreet Singh. "APPLICATION OF QUALITY BY DESIGN APPROACH FOR THE OPTIMIZATION OF ORODISPERSIBLE FILM FORMULATION." Asian Journal of Pharmaceutical and Clinical Research 11, no. 14 (July 27, 2018): 8. http://dx.doi.org/10.22159/ajpcr.2018.v11s2.28508.

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Objective: The present study was done to understand the effect of formulation variables on the quality of orodispersible films using quality by design (QbD) approach as mentioned in ICH Q8 (R2) guideline.Methods: A definitive screening design of experiments (DoE) was used to identify and classify the critical formulation variables affecting critical quality attributes (CQA) using 2×2 factorial design. Based on prescreening study, the critical formulation variables, i.e. concentration of film-forming polymer and plasticizers (propylene glycol and polyethylene glycol 400 [PEG 400]) were kept in the range of 1.5–2.5% w/w and 0.5–1% v/v, respectively. A total of eight laboratory-scale formulations were prepared which were provided by DoE using solvent casting method. These batches were evaluated for CQA’s, i.e. mechanical properties such as folding endurance (FD) and disintegration time (DT). Data were analyzed for elucidating interactions between two variables and for providing a predictive model for the process. Finally, the drug was incorporated into optimized batches, and these were evaluated for in vitro dissolution study in simulated saliva (pH 6.8) as well as their mechanical properties.Results: The results suggested that the concentration of film-forming polymer and plasticizer was critical to manufacture orodispersible film with desired CQA, i.e. mechanical property (FD [>150 folds]) and DT (<60 s). The percent drug release, FD, and DT of optimized Formulation I (hydroxypropyl methylcellulose [HPMC] E5 (2%) and propylene glycol [0.15 mL]) were found to be 82.13%±0.260 (in 15 min), 164±2, and 49±1.5 s, respectively, and for optimized Formulation II (HPMC E5 [2%] and PEG 400 [0.15 mL]) was found to be 64.26%±2.026 (in 15 min) and 218±6 and 55±4 s, respectively.Conclusion: From the results, it has been found that the percentage drug release of naratriptan hydrochloride containing propylene glycol as a plasticizer was greater than the formulation containing PEG 400 as plasticizer. From this, we concluded that QbD is very much useful approach to get an optimized formulation in an economic and faster way in comparison to traditional method (hit and trail methods). The futuristic application of the film will involve the management of an acute migraine.

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Centkowska, Katarzyna, Elżbieta Ławrecka, and Malgorzata Sznitowska. "Technology of Orodispersible Polymer Films with Micronized Loratadine—Influence of Different Drug Loadings on Film Properties." Pharmaceutics 12, no. 3 (March 10, 2020): 250. http://dx.doi.org/10.3390/pharmaceutics12030250.

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The production of orodispersible films (ODFs) with suspended insoluble drug substances is still a challenge, mainly due to the difficulty associated with achieving a proper homogeneity and mechanical properties of the films. Hypromellose (HPMC) and a mixture of polyvinyl alcohol (AP) and povidone (PVP) were compared in terms of their suitability for ODFs incorporating suspended micronized loratadine (LO) in a concentration range of 10%–40%. In a planetary mixer (Thinky), a uniform dispersion of LO in an aqueous viscous casting solution was obtained. The suspended LO particles caused dose-dependent changes in the viscosity of the casting mass and affected the mechanical quality of ODFs. Drug concentrations higher than 30% reduced the film flexibility and tear resistance, depending on the polymer type. LO films with a thickness of 100 µm disintegrated within 60-100 s, with no significant influence of the LO content in the range 10%–30%. HPMC films, regardless of the drug concentration, met the pharmacopoeial requirements regarding the uniformity of the drug content. AP/PVP films were too elastic, and the drug content uniformity was not achieved. The conclusion is that, using an HPMC matrix, it is possible to obtain a high load of a poorly water-soluble drug (30% of dry film mass corresponds to a dose of 5 mg per 1.5 cm2) in ODFs characterized by proper physical characteristics.

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Desai, Neel, Marc Masen, Philippa Cann, Ben Hanson, Catherine Tuleu, and Mine Orlu. "Modernising Orodispersible Film Characterisation to Improve Palatability and Acceptability Using a Toolbox of Techniques." Pharmaceutics 14, no. 4 (March 29, 2022): 732. http://dx.doi.org/10.3390/pharmaceutics14040732.

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Orodispersible films (ODFs) have been widely used in paediatric, geriatric and dysphagic patients due to ease of administration and precise and flexible dose adjustments. ODF fabrication has seen significant advancements with the move towards more technologically advanced production methods. The acceptability of ODFs is dependent upon film composition and process of formation, which affects disintegration, taste, texture and mouthfeel. There is currently a lack of testing to accurately assess ODFs for these important acceptability sensory perceptions. This study produced four ODFs formed of polyvinyl alcohol and sodium carboxymethylcellulose using 3D printing. These were assessed using three in vitro methods: Petri dish and oral cavity model (OCM) methods for disintegration and bio-tribology for disintegration and oral perception. Increasing polymer molecular weight (MW) exponentially increased disintegration time in the Petri dish and OCM methods. Higher MW films adhered to the OCM upper palate. Bio-tribology analysis showed that films of higher MW disintegrated quickest and had lower coefficient of friction, perhaps demonstrating good oral perception but also stickiness, with higher viscosity. These techniques, part of a toolbox, may enable formulators to design, test and reformulate ODFs that both disintegrate rapidly and may be better perceived when consumed, improving overall treatment acceptability.

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Saokham, Phennapha, Kanokporn Burapapadh, Narumon Changsan, and Chutima Sinsuebpol. "Preparation and Characterization of Orodispersible Films Loaded Diclofenac Sodium/β-Cyclodextrin Inclusion Complexes." Key Engineering Materials 901 (October 8, 2021): 86–91. http://dx.doi.org/10.4028/www.scientific.net/kem.901.86.

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Orodispersible films (ODFs) is orally pharmaceutical dosage form that rapidly disintegrates and instantly releases the drug when placed on the tongue. This study was firstly aimed to investigate physicomechanical properties of ODFs containing diclofenac sodium/β-cyclodextrin (DS/βCD) inclusion complexes prepared by solvent casting method. The influence of plasticizer, βCD and DS on hydroxypropyl metlhycellulose (HPMC) film was studied. Increasing of plasticizer concentration (e.g. PEG400 amd glycerol) resulted in decrement of disintegration time, strength and elasticity of HPMC films. When βCD was incorporated, opaque films were observed. Presence of βCD resulted in degrading of physicomechanical properties, except percentage of elongation representing the film’s elasticity. βCD films containing DS (DS/βCD films) were more brittle and transparent than blank βCD films. Amount of incorporated DS influenced on disintegration time and strength of obtained films. Cross-section scanning electron microscope (SEM) photomicrographs showed spherical particles scattered on DS/βCD films illustrating the occurrence of DS/βCD inclusion complexes during casting process. The DS/βCD inclusion complexes were then confirmed in both solid and solution. Furthermore, DS/βCD ODFs were prepared by incorporation of artificial sweeteners in DS/βCD films. It was found that DS/βCD ODFs containing xylitol were more brittle and their disintegration times were faster then those containing sucralose. Dissolution profiles were investigated then reported that release kinetic of DS/βCD films and ODFs were fitted to Higuchi model. In summary, the βCD-based ODFs containing DS were successfully developed.

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Latif, Sumera, Uzma Barkat, Hafsa Afzal, Nasir Abbas, shaista qamar, Rahat shamim, and Amjad hussain. "DEVELOPMENT AND CHARACTERIZATION OF TASTE MASKED ORODISPERSIBLE FILM OF CHLORPROMAZINE HYDROCHLORIDE." Acta Poloniae Pharmaceutica - Drug Research 78, no. 1 (April 7, 2021): 97–106. http://dx.doi.org/10.32383/appdr/132020.

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O’Reilly, Colm S., Moe Elbadawi, Neel Desai, Simon Gaisford, Abdul W. Basit, and Mine Orlu. "Machine Learning and Machine Vision Accelerate 3D Printed Orodispersible Film Development." Pharmaceutics 13, no. 12 (December 17, 2021): 2187. http://dx.doi.org/10.3390/pharmaceutics13122187.

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Orodispersible films (ODFs) are an attractive delivery system for a myriad of clinical applications and possess both large economical and clinical rewards. However, the manufacturing of ODFs does not adhere to contemporary paradigms of personalised, on-demand medicine, nor sustainable manufacturing. To address these shortcomings, both three-dimensional (3D) printing and machine learning (ML) were employed to provide on-demand manufacturing and quality control checks of ODFs. Direct ink writing (DIW) was able to fabricate complex ODF shapes, with thicknesses of less than 100 µm. ML algorithms were explored to classify the ODFs according to their active ingredient, by using their near-infrared (NIR) spectrums. A supervised model of linear discriminant analysis was found to provide 100% accuracy in classifying ODFs. A subsequent partial least square algorithm was applied to verify the dose, where a coefficient of determination of 0.96, 0.99 and 0.98 was obtained for ODFs of paracetamol, caffeine, and theophylline, respectively. Therefore, it was concluded that the combination of 3D printing, NIR and ML can result in a rapid production and verification of ODFs. Additionally, a machine vision tool was used to automate the in vitro testing. These collective digital technologies demonstrate the potential to automate the ODF workflow.

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Jani, Rushiraj, and Dasharath Patel. "Hot melt extrusion: An industrially feasible approach for casting orodispersible film." Asian Journal of Pharmaceutical Sciences 10, no. 4 (July 2015): 292–305. http://dx.doi.org/10.1016/j.ajps.2015.03.002.

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Wasilewska, Katarzyna, and Katarzyna Winnicka. "How to assess orodispersible film quality? A review of applied methods and their modifications." Acta Pharmaceutica 69, no. 2 (June 1, 2019): 155–76. http://dx.doi.org/10.2478/acph-2019-0018.

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Abstract In recent years, there has been a tendency toward creating innovative, easy to use and patient-friendly drug delivery systems suitable for every consumer profile, which would ensure safety, stability and acceptability of a drug. One of the relatively novel and promising approaches is the manufacture of orodispersible films (ODFs), which is an upcoming area of interest in drug delivery. They are defined as polymer thin films that disintegrate in the oral cavity within seconds, without drinking water or chewing, and eliminate the risk of choking. Gaining special usefulness in therapies of children and the elderly, ODFs seem to fill the gap in the range of preparations available for these groups of patients. As no detailed monography of ODFs including testing methods and uniform requirements has been presented in any of the pharmacopoeias to date, the aim of this article is to give an overview of the applied testing methods, their modifications and innovative approaches related to ODF quality assessment.

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Kanekar, H., A. Khale, S. Maurya, and B. Dey. "PHASE SOLUBILITY STUDIES OF ONDANSETRON -2- HYDROXYPROPYL BETACYCLODEXTRIN FOR DEVELOPMENT OF ONDANSETRON ORODISPERSIBLE FILMS." INDIAN DRUGS 53, no. 08 (August 28, 2016): 53–56. http://dx.doi.org/10.53879/id.53.08.10589.

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The present research work was aimed to formulate transparent mouth dissolving films of ondansetron. Ondansetron is poorly soluble in aqueous solvents (less than 5 mg/mL) and thus improvisation in solubility was crucial. The phase solubility studies were carried in order to study the formation of inclusion complex with Hydroxy Propyl Beta cyclodextrin. The phase solubility diagrams revealed the formation of stable inclusion complex and apparent stability constants were evaluated. The calculated apparent stability constant, Kc was found to be 288.5 mol-1. The shape of solubility graph indicated that there is probability of the formation of 1:1complex with respect to HP-b-CD concentration (Slope of less than 1). The Scanning Electron Microscopy study of plain ondansetron and ondansetron orodispersible film revealed the formation of stable inclusion complex, which renders the complete solubilisation of ondansetron, yielding the formation of transparent mouth dissolving films.

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Zhaparkulova, K. A., G. M. Gani, Z. B. Sakipova, and A. A. Karaubayeva. "Development of the orodispersible films based on CO2 extract of Ziziphora bungeana with antimicrobial activity." Bulletin of the Karaganda University. "Chemistry" series 100, no. 4 (December 30, 2020): 128–34. http://dx.doi.org/10.31489/2020ch4/128-134.

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The present work was intended to develop the new drug in the form of film soluble in the oral cavity: development of its composition, production technology, the study of its antimicrobial activity. The relevance of the problem is caused by the absence of drugs in the form of films on the domestic pharmaceutical market. The optimal composition of films was selected by evaluating a number of physical, chemical and technological indicators of the obtained films. The article indicates the materials used to obtain the drugs in question, presents the technology for their preparation and quality determination methods: unit measurement methods and potentiometric determination of pH, tensiometric and conductometric methods, thin-layer and gas chromatography and others. Antimicrobial activity of the resulting films has been proven in vitro. Staphylococcus aureus ATCC 6538-p and Escherichia coli ATCC 8739 have been used as the test microorganisms in order to study them by disk diffusion method in agar. The introduction of СО2 extract of Z. bungeana from medicinal plant raw materials as active ingredients in medicinal films will expand the range of complex phytopreparations of the domestic pharmaceutical market for the treatment of inflammatory diseases of the oral mucosa.

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Park, Sang-In, Su-Hak Heo, Gihwan Kim, Seokhoon Chang, Keon-Hyoung Song, Min-Gul Kim, Eun-Heui Jin, JaeWoo Kim, SeungHwan Lee, and Jang Hee Hong. "Comparison of tadalafil pharmacokinetics after administration of a new orodispersible film versus a film-coated tablet." Drug Design, Development and Therapy Volume 12 (April 2018): 935–42. http://dx.doi.org/10.2147/dddt.s155040.

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Panraksa, Pattaraporn, Sheng Qi, Suruk Udomsom, Pratchaya Tipduangta, Pornchai Rachtanapun, Kittisak Jantanasakulwong, and Pensak Jantrawut. "Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film." Polymers 13, no. 20 (October 9, 2021): 3454. http://dx.doi.org/10.3390/polym13203454.

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The application of hydrophilic polymers in designing and three-dimensional (3D) printing of pharmaceutical products in various dosage forms has recently been paid much attention. Use of hydrophilic polymers and syringe extrusion 3D printing technology in the fabrication of orodispersible films (ODFs) might hold great potential in rapid drug delivery, personalized medicine, and manufacturing time savings. In this study, the feasibility of 3D-printed ODFs fabrication through a syringe extrusion 3D printing technique and using five different hydrophilic polymers (e.g., hydroxypropyl methylcellulose E15, hydroxypropyl methylcellulose E50, high methoxyl pectin, sodium carboxymethylcellulose, and hydroxyethylcellulose) as film-forming polymers and printing materials has been investigated. Rheology properties and printability of printing gels and physicochemical and mechanical properties of 3D-printed ODFs were evaluated. Amongst the investigated hydrophilic polymers, sodium carboxymethylcellulose at a concentration of 5% w/v (SCMC-5) showed promising results with a good printing resolution and accurate dimensions of the 3D-printed ODFs. In addition, SCMC-5 3D-printed ODFs exhibited the fastest disintegration time within 3 s due to high wettability, roughness and porosity on the surface. However, the results of the mechanical properties study showed that SCMC-5 3D printed ODFs were rigid and brittle, thus requiring special packaging to prevent them from any damage before practical use.

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Ruchi Sharma, Deepika Joshi, Bhavana Singh, and Nidhi Semwal. "A review on orodispersible film a novel approach of drug delivery system." World Journal of Biology Pharmacy and Health Sciences 12, no. 1 (October 30, 2022): 001–11. http://dx.doi.org/10.30574/wjbphs.2022.12.1.0130.

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The effective distribution of the drug to the body is the main objective of every drug delivery mechanism, but patient compliance must also be taken into consideration. Fasat-dissolving drug delivery technologies, such Or dispersible Films (ODFs), make it simple to administer medication to the general public as well as to certain demographic groups with swallowing issues, like youngsters and the elderly. ODFs are cutting-edge dosage forms that dissolve and disintegrate inside the mouth. Intra-oral absorption enables quick action and aids in avoiding first-pass effects, reducing the unit dose needed to deliver the desired therapeutic effect. In comparison to ODTs, or dispersible films dissolve and disintegrate in less than one minute with very little saliva moisture. It can be used safely even if water is not available, as or dispersible films require the use of water.

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Cocci, A., M. Capece, G. Cito, G. I. Russo, M. Falcone, M. Timpano, M. Rizzo, et al. "317 Effectiveness and safety of orodispersible Sildenafil in a new film formulation for the treatment of erectile dysfunction: comparison between Sildenafil 100 mg film-coated tablet (FCT) vs 75 mg orodispersible film (ODF)." Journal of Sexual Medicine 15, no. 7 (July 2018): S252—S253. http://dx.doi.org/10.1016/j.jsxm.2018.04.280.

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Journal articles on the topic 'Orodispersible film'

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