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Optimized Taste-Masked Microparticles for Orally Disintegrating Tablets as a Promising Dosage Form for Alzheimer’s Disease Patients
- Source :
- Pharmaceutics, Volume 13, Issue 7, Pharmaceutics, Vol 13, Iss 1046, p 1046 (2021)
- Publication Year :
- 2021
- Publisher :
- Multidisciplinary Digital Publishing Institute, 2021.
-
Abstract
- The objective of this research was to optimize the tasted-masked microparticles for orally disintegrating tablets containing donepezil hydrochloride using quality risk assessment and design of experiment approaches. The double emulsion solvent evaporation technique using aminoalkyl methacrylate copolymer (AMC) was used to prepare taste-masked microparticles. Factors affecting the quality of the taste-masked microparticles were analyzed using an Ishikawa diagram. A risk-ranking approach was used to rank the formulation and process risks. Furthermore, the effect of AMC quantity, stirring time, and volume of outer water phase on various responses, such as particle size, the amount of drug dissolved at 5 min (Q5) in simulated saliva fluid, and mean dissolution time (MDT) in simulated gastric fluid, was investigated using the Box-Behnken design. The optimized microparticles were then used to prepare orally disintegrating tablets (ODTs) and evaluated by in vitro and in vivo testing. The results demonstrated that particle size was influenced by the AMC amount and stirring time. Q5 was significantly affected by the amount of AMC and the volume of the outer water phase. On the other hand, these two factors had a positive effect on MDT. The optimized microparticles had a particle size of 174.45 ± 18.19 µm, Q5 of 5.04%, and MDT of 5.97 min. The ODTs with taste-masked microparticles showed acceptable in vitro dissolution with an MDT of 5 min. According to the results of a panel of six human volunteers, they greatly improved palatability.
- Subjects :
- microparticles
Chromatography
Gastric fluid
Methacrylate copolymer
Chemistry
Pharmaceutical Science
02 engineering and technology
orally disintegrating tablets
021001 nanoscience & nanotechnology
030226 pharmacology & pharmacy
Box–Behnken design
donepezil hydrochloride
Article
Dosage form
taste masking
RS1-441
03 medical and health sciences
Double emulsion solvent evaporation
Pharmacy and materia medica
0302 clinical medicine
In vivo
Particle size
Box-Behnken design
0210 nano-technology
Dissolution
Subjects
Details
- Language :
- English
- ISSN :
- 19994923
- Database :
- OpenAIRE
- Journal :
- Pharmaceutics
- Accession number :
- edsair.doi.dedup.....5f5a32fc0988bded66fffd7753035831
- Full Text :
- https://doi.org/10.3390/pharmaceutics13071046