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Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Development of orally disintegrating tablets comprising controlled-release multiparticulate beads
Gopi M Venkatesh1, Phillip J Stevens, Jin-Wang Lai
1Aptalis Pharma R & D, Vandalia, OH 45377, USA. gopi.venkatesh@aptalispharma.com
Drug Development and Industrial Pharmacy
|February 24, 2012
Summary
New controlled-release melperone (an atypical antipsychotic) capsule and orally disintegrating tablet (ODT) formulations offer a convenient once-daily option. These melperone formulations are suitable for patients with swallowing difficulties, advancing clinical development.
Area of Science:
- Pharmacology
- Pharmaceutics
- Geriatric Medicine
Background:
- Melperone is an atypical antipsychotic used for senile dementia and Parkinson's-associated psychosis.
- Current formulations include immediate-release (IR) tablets and syrup, posing challenges for patients with dysphagia.
Purpose of the Study:
- To develop controlled-release (CR) melperone hydrochloride capsule and orally disintegrating tablet (ODT) formulations.
- To establish suitability for once-daily dosing and assess potential for clinical development.
Main Methods:
- Development of CR capsule and ODT formulations with specific in vitro release profiles.
- In vivo bioequivalence testing of 50 mg formulations against IR syrup.
- Analytical, organoleptic, blend uniformity, and compression testing at a 1/10 commercial scale.
Main Results:
- Two medium-release formulations (capsule and ODT) demonstrated bioequivalence.
- Both CR capsule and ODT formulations showed suitability for once-daily administration.
- Formulations exhibited acceptable analytical, organoleptic, and manufacturing characteristics.
Conclusions:
- Developed CR melperone capsules and ODTs are suitable for once-daily dosing.
- These novel formulations address swallowing difficulties and advance melperone therapy.
- Both dosage forms are recommended for further clinical investigation.
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