FORMULATION OF POMEPOSE HARD CAPSULE FROM IMMATURE POMELO

Hoàng Chung Nguyễn1, Minh Nhựt Trương1, Hữu Lạc Thủy Nguyễn1,, Văn Đạt Trương1, Thanh Hà Nguyễn2
1 University of Medicine and Pharmacy at Ho Chi Minh City
2 Ho Chi Minh City Drug Testing Institute

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Abstract

Objectives: To formulate the hard capsule from immature pomelo. Subjects and Methods: Immature pomelo extract was evaluated for compatibility with several common excipients then investigated the formula and preparation process for PomePose capsules. Results: Immature pomelo extract was compatible with low density CSD, MgCO3, Florite R, avicel-102, aerosil, magnesium stearate, sodium croscarmellose. PomePose capsules were prepared by wet granulation technique with the following ingredients: 250 mg of immature pomelo extract; 160 mg of CSD; 22 mg of avicel 102; 9 mg of sodium croscarmellose; 4.5 mg of magnesium stearate; and 4.5 mg of aerosil. The capsules met the requirements for disintegration, mass uniformity and stability after 14 days of storage at extreme conditions (temperature 60 oC, relative humidity 75 %). The content of naringin in PomePose capsules was 53.89 mg. Conclusion: The research has successfully developed the formula and process of preparing PomPose capsules with a scale of 1,000 tablets/batch. The preparation process is stable and can be applied on a larger scale of production.

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References

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