| The impact of formulation and process changes on in vitro dissolution and the bioequivalence of piroxicam capsules. | |
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MedLine Citation:
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PMID: 9834946 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The purpose of this research was to determine the effect of major compositional changes on the bioavailability of piroxicam from immediate-release formulations filled in hard gelatin capsules. The capsules were manufactured according to a 2(5-1) + star point (resolution V) experimental design to investigate the effects of sodium lauryl sulfate level, magnesium stearate level, lactose/microcrystalline cellulose ratio, piroxicam particle size, and lubricant blending time. Sodium lauryl sulfate level, lactose level, and piroxicam particle size were the most important main effects affecting dissolution. Lubricant level and lubricant blending time were either not significant (5% level) or were among the lowest ranking of factors affecting dissolution in standardized pareto analysis. Three of these formulations exhibiting slow, medium, and fast dissolution were compared to a single lot of the Innovator (commercial) product in a small bioavailability study. The slow formulation did not meet the USP dissolution specification for piroxicam capsules. Compositionally, the experimental formulations represented major changes in piroxicam particle size, level of filler, and level of sodium lauryl sulfate. Sixteen healthy volunteers received each formulation (20 mg) in a four-way crossover design. The three Maryland manufactured formulations were bioequivalent with the commercial product and were also bioequivalent among themselves. The major changes incorporated into these formulations did not result in major differences in bioavailability. The dissolution profiles which discriminated between the formulations in vitro did not accurately represent the in vivo bioavailability results. The results of this study are part of the research database that supports SUPAC-IR, an FDA guidance that provides relaxed testing and filing requirements for scale-up and post-approval changes to immediate-release oral solid dosage forms. |
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Authors:
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D A Piscitelli; S Bigora; C Propst; S Goskonda; P Schwartz; L J Lesko; L Augsburger; D Young |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Pharmaceutical development and technology Volume: 3 ISSN: 1083-7450 ISO Abbreviation: Pharm Dev Technol Publication Date: 1998 Nov |
Date Detail:
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Created Date: 1999-02-25 Completed Date: 1999-02-25 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 9610932 Medline TA: Pharm Dev Technol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 443-52 Citation Subset: IM |
Affiliation:
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Department of Pharmaceutical Sciences, University of Maryland at Baltimore, Baltimore, Maryland, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-Inflammatory Agents, Non-Steroidal / administration & dosage* Biological Availability Capsules Chemistry, Pharmaceutical Female Humans Male Piroxicam / administration & dosage*, pharmacokinetics Solubility Therapeutic Equivalency |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Capsules; 36322-90-4/Piroxicam |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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