Evaluation of the impact of sodium lauryl sulfate source variability on solid oral dosage form development

Autor:	Z. Jane Li, Jocelyn A. Gunn, Leon Schultz, Dongmei Qiang
Rok vydání:	2010
Předmět:	Materials science Pyridines Chemistry Pharmaceutical Pharmaceutical Science Granulation Surface-Active Agents Drug Discovery Surface Tension Solubility Micronization Particle Size Dissolution Micelles Pharmacology Active ingredient Supersaturation Chromatography integumentary system Organic Chemistry Sodium Dodecyl Sulfate Azepines Critical micelle concentration Reverse Transcriptase Inhibitors Wetting Tablets
Zdroj:	Drug development and industrial pharmacy. 36(12)
ISSN:	1520-5762
Popis:	Objective: The objective of this study was to investigate the effects of sodium lauryl sulfate (SLS) from different sources on solubilization/wetting, granulation process, and tablet dissolution of BILR 355 and the potential causes. Methods: The particle size distribution, morphology, and thermal behaviors of two pharmaceutical grades of SLS from Spectrum and Cognis were characterized. The surface tension and drug solubility in SLS solutions were measured. The BILR 355 tablets were prepared by a wet granulation process and the dissolution was evaluated. Results: The critical micelle concentration was lower for Spectrum SLS, which resulted in a higher BILR 355 solubility. During wet granulation, less water was required to reach the same end point using Spectrum than Cognis SLS. In general, BILR 355 tablets prepared with Spectrum SLS showed a higher dissolution than the tablets containing Cognis SLS. Micronization of SLS achieved the same improved tablet dissolution as micronized active pharmaceutical ingredient. Conclusions: The observed differences in wetting and solubilization were likely due to the different impurity levels in SLS from two sources. This study demonstrated that SLS from different sources could have significant impact on wet granulation process and dissolution. Therefore, it is critical to evaluate SLS properties from different suppliers, and then identify optimal formulation and process parameters to ensure robustness of drug product manufacture process and performance.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6ed58d1038f49737fa5bccfd156c3563 https://pubmed.ncbi.nlm.nih.gov/20545515 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.