Technical note: Non-sink dissolution media for identification of functional formulation excipients-the case of a precipitation inhibitor

Dissolution Technologies

Volumn 20, Issue 4, 2013, Pages 39-41

  Cruañes, Maria T ^a   Bentz, Kimberly ^a   Xu, Wei ^a   Artino, Laura ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Antinucleating agent; Antiprecipitating agent; Excipient selection; Low solubility compound; Media selection; Non sink conditions; Precipitation inhibitor; Supersaturation; Transient solubility

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENT; BUFFER; CHEMICALS AND DRUGS; CITRIC ACID; EXCIPIENT; HYDROCHLORIC ACID; HYDROXYPROPYLMETHYLCELLULOSE; PHOSPHATE; UNCLASSIFIED DRUG;

CHEMICAL ENVIRONMENT; CHEMICAL PHENOMENA; DISSOLUTION; DISSOLUTION MEDIA; DRUG CONCENTRATION; NOTE; NUCLEATION; PH; PKA; PRECIPITATION; SOLUBILITY; SUPERSATURATION;

EID: 84889822662     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT200413P39     Document Type: Note

References (4)

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2. Raghavan, S. L.; Trividic, A.; Davis, A. F.; Hadgraft, J. Crystallization of hydrocortisone acetate: influence of polymers. Int. J. Pharm. 2001, 212 (2), 213-221.
3. Kibbe, A. H., Ed. Handbook of Pharmaceutical Excipients, 3rd ed.; American Pharmaceutical Association: Washington, DC, 2000; pp 60-63.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development, Q8(R2); ICH Harmonized Tripartite Guideline: Geneva, Switzerland, 2009. http://www. ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (accessed Oct 18, 2013).