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Formulation Optimization and in Vitro Characterization of Orally Disintegrating Films Using a Factorial Design and Mathematical Modeling for Drug Release
- Source :
- CHEMICAL & PHARMACEUTICAL BULLETIN. 65:166-177
- Publication Year :
- 2017
- Publisher :
- Pharmaceutical Society of Japan, 2017.
-
Abstract
- Even though experimental designs are becoming popular especially for conventional dosage forms, limited studies have been performed to optimize formulations of orally disintegrating films (ODFs). This study aimed to evaluate sildenafil citrate-loaded ODFs for a controlled release with hydroxypropyl methylcellulose as a film-forming polymer. A factorial design was utilized for optimization with three control factors: ethanol ratio, plasticizer ratio, and the type of plasticizer. Tensile strength, disintegration time, water contact angle, and thickness were chosen as responses. For optimization, water contact angle, disintegration time, and thickness were minimized, while the tensile strength was maximized. Based on the conditions, optimal formulations were achieved for each type of plasticizer. Evaluation of desirability indicated that the response values were close to the target. When these optimal formulations were validated, the optimal solutions and target values were similar with small biases. The formulations were characterized using scanning electron microscopy, differential scanning calorimetry, Fourier transform infrared spectroscopy, surface pH, in vitro dissolution, and drug release simulation with a mathematical modeling. After the drug was homogenously dispersed throughout the film, the crystalline form of the drug provided strong hydrogen bonds between the drug and the film components. Moreover, it showed a controlled drug release profiles that were well matched with simulated results. This study suggests that the optimized films may present a better alternative to conventional tablets for the treatment of male erectile dysfunction.
- Subjects :
- Chemistry, Pharmaceutical
Drug Compounding
Administration, Oral
02 engineering and technology
Pharmacology
030226 pharmacology & pharmacy
Sildenafil Citrate
Dosage form
Contact angle
03 medical and health sciences
Hypromellose Derivatives
0302 clinical medicine
Differential scanning calorimetry
Plasticizers
Tensile Strength
Drug Discovery
Ultimate tensile strength
Composite material
chemistry.chemical_classification
Plasticizer
General Chemistry
General Medicine
Polymer
Factorial experiment
021001 nanoscience & nanotechnology
Controlled release
Drug Liberation
Models, Chemical
Solubility
chemistry
0210 nano-technology
Subjects
Details
- ISSN :
- 13475223 and 00092363
- Volume :
- 65
- Database :
- OpenAIRE
- Journal :
- CHEMICAL & PHARMACEUTICAL BULLETIN
- Accession number :
- edsair.doi.dedup.....e0286b9bdae9946fdf388694286b39b5