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Low-viscosity hydroxypropylcellulose (HPC) grades SL and SSL: versatile pharmaceutical polymers for dissolution
Ashish Sarode1, Peng Wang, Catherine Cote
1Department of Biomedical and Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, Rhode Island 02881, USA.
AAPS Pharmscitech
|December 20, 2012
Summary
Low-viscosity hydroxypropylcellulose (HPC) polymers effectively enhance drug dissolution and enable sustained release. HPC-SL and HPC-SSL are chemically stable excipients for creating amorphous solid dispersions of various drugs using diverse pharmaceutical processes.
Area of Science:
- Pharmaceutical Science
- Materials Science
- Drug Delivery Systems
Background:
- Hydroxypropylcellulose (HPC) polymers, specifically HPC-SL and HPC-SSL, are recognized for their versatility as pharmaceutical excipients.
- Their application in enhancing drug dissolution and achieving sustained drug release warrants detailed investigation across various processing techniques.
Purpose of the Study:
- To evaluate the efficacy of low-viscosity hydroxypropylcellulose polymers (HPC-SL and HPC-SSL) in improving dissolution and controlling release of pharmaceutical drugs.
- To assess the impact of different manufacturing processes, including hot melt mixing (HMM), solvent evaporation (SE), and ball milling (BM), on drug properties and stability.
Main Methods:
- Preparation of solid dispersions (SDs) using carbamazepine (CBZ), hydrochlorothiazide, phenytoin (PHT), and chlorpheniramine maleate (CPM) with HPC polymers.
- Evaluation of amorphous transformation, drug degradation, and dissolution characteristics of the prepared SDs.
- Comparison of different processing techniques (HMM, SE, BM) for their impact on drug properties.
Main Results:
- Hot melt mixing successfully induced amorphous transformation in low-melting drugs like carbamazepine and chlorpheniramine maleate.
- Solvent evaporation and ball milling did not yield amorphous solid dispersions of phenytoin using HPC-SSL.
- All tested drugs maintained chemical stability throughout the hot melt mixing process with HPC.
- HPC-based hot melt mixtures demonstrated significant dissolution enhancement, comparable to other polymers.
- The order of dissolution enhancement for phenytoin was observed as SE > BM > HMM > physical mixtures.
- HPC polymers facilitated significant sustained release of chlorpheniramine maleate in simulated gastric and intestinal fluids.
Conclusions:
- Low-viscosity hydroxypropylcellulose polymers (HPC-SL and HPC-SSL) are effective in producing chemically stable amorphous solid dispersions.
- These polymers can be utilized with various pharmaceutical processes to control the dissolution of both poorly and highly water-soluble drugs.
- HPC polymers offer a viable strategy for both dissolution enhancement and sustained drug release applications.
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