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Preparation and evaluation of combination tablet containing incompatible active ingredients
Xiaoyan Wang1, Fude Cui, Yorinobu Yonezawa
1Faculty of Pharmacy, Meijo University, Nagoya, Japan.
Chemical & Pharmaceutical Bulletin
|July 5, 2003
Summary
This study developed stable combination tablets of aspirin and ranitidine hydrochloride, overcoming drug incompatibility. Optimized granulation and coating techniques ensure effective drug delivery and improved stability for these widely used medications.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Formulation Science
Background:
- Combination drug formulations offer enhanced therapeutic benefits with reduced side effects.
- Chemical incompatibility between active pharmaceutical ingredients (APIs) and excipients poses significant challenges in developing solid dosage forms.
- Developing stable and effective combination solid dosage forms requires overcoming formulation hurdles.
Purpose of the Study:
- To develop a stable combination solid dosage form of aspirin and ranitidine hydrochloride, addressing their known chemical interaction.
- To optimize the preparation process for individual drug components using advanced granulation and coating technologies.
- To evaluate the quality attributes, including dissolution, content uniformity, and stability, of the final combination tablets.
Main Methods:
- Aspirin was granulated using hydroxypropyl methyl cellulose (HPMC) binder, with process parameters optimized via Artificial Neural Network (ANN) analysis.
- Ranitidine hydrochloride was prepared using a preliminary granulation followed by Aquacoat (ethyl cellulose aqueous dispersion) coating via Wurster fluid bed coating.
- Optimized aspirin granules and coated ranitidine hydrochloride particles were co-compressed into tablets with appropriate excipients.
Main Results:
- Optimized granulation conditions yielded aspirin granules with excellent flowability and compressibility.
- The developed formulation demonstrated good dissolution profiles for both active ingredients.
- The combination tablets exhibited uniform drug content and enhanced stability of aspirin and ranitidine hydrochloride.
Conclusions:
- A robust method for preparing combination tablets of chemically incompatible drugs like aspirin and ranitidine hydrochloride was successfully established.
- The optimized formulation and manufacturing process ensure the quality, stability, and therapeutic efficacy of the combined dosage form.
- This approach provides a viable strategy for developing other challenging combination solid dosage forms.