Use of a Moist Granulation Technique (MGT) to Develop Controlled-Release Dosage Forms of Acetaminophen

The moist granulation technique (MGT), which involves agglomeration and moisture absorption, has only been applied to immediate-release dosage forms. Our results indicate that MGT appears to be applicable in developing a controlled-release formulation. A small amount of granulating fluid (water) was...

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Bibliographic Details
Published in:Drug development and industrial pharmacy 2001-01, Vol.27 (4), p.337-343
Main Authors: Railkar, Aniruddha M., Schwartz, Joseph B.
Format: Article
Language:English
Subjects:
Absorption
Acetaminophen - administration & dosage
Acetaminophen - chemistry
Agglomeration
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - chemistry
Biological and medical sciences
Cellulose - analogs & derivatives
Cellulose - chemistry
Chemistry, Pharmaceutical - methods
Controlled release
Delayed-Action Preparations
General pharmacology
Medical sciences
Moist granulation technique
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Water
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Summary:The moist granulation technique (MGT), which involves agglomeration and moisture absorption, has only been applied to immediate-release dosage forms. Our results indicate that MGT appears to be applicable in developing a controlled-release formulation. A small amount of granulating fluid (water) was added to a powder blend to activate a dry binder (such as polyvinylpyrrolidone [PVP] at 2% and 3.6%) and to facilitate agglomeration. Then, a moisture-absorbing material (microcrystalline cellulose [MCC]) was added to absorb any excess moisture. By adding MCC in this way, a drying step was not necessary. Acetaminophen (APAP) was the model drug, with diluents lactose FastFlo® and dicalcium phosphate. Hydroxypropylcellulose (HPC) was used as the controlled-release agent. The MGT was compared to conventional wet granulation (WG) and direct compression (DC) processing methods. The results indicate that MGT appears to be applicable in developing a controlled-release formulation. Particle size distribution of MGT and WG batches containing 3.6% PVP is similar.
ISSN:0363-9045
1520-5762
DOI:10.1081/DDC-100103733