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Parra, Mario González-de la
- Application of Sequential Design of Experiments to Develop Ibuprofen (400 mg) Tablets by Direct Compression
Abstract Views :451 |
PDF Views:210
Authors
Affiliations
1 School of Chemistry, Universidad Nacional Autonoma de Mexico (UNAM), Mexico City, Mexico, MX
2 Biokinetics, S.A. de C.V., Mexico City, Mexico, MX
1 School of Chemistry, Universidad Nacional Autonoma de Mexico (UNAM), Mexico City, Mexico, MX
2 Biokinetics, S.A. de C.V., Mexico City, Mexico, MX
Source
Asian Journal of Chemistry and Pharmaceutical Sciences, Vol 2, No 1 (2017), Pagination: 10-15Abstract
A strategy based on sequential design of experiments (screening, optimization and confirmation) was used to develop a tablet formulation of ibuprofen (400 mg) that is manufactured by direct compression. This formulation has a high content of ibuprofen (76%), in spite of the poor flowability of the drug substance. Sequential design of experiments proved to be an effective and efficient strategy in formulation development.Keywords
Central-Composite Design, Design Of Experiments, Direct Compression, Ibuprofen, Simplex-Screening Design.Full Text
References
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- Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation
Abstract Views :440 |
PDF Views:201
Authors
Affiliations
1 School of Chemistry, Universidad Nacional Autónoma de México (UNAM), México City, México, MX
2 Fundación Liomont, A.C., Mexico City, Mexico, MX
3 Biokinetics, S.A. de C.V., Mexico City, Mexico, MX
1 School of Chemistry, Universidad Nacional Autónoma de México (UNAM), México City, México, MX
2 Fundación Liomont, A.C., Mexico City, Mexico, MX
3 Biokinetics, S.A. de C.V., Mexico City, Mexico, MX
Source
Asian Journal of Chemistry and Pharmaceutical Sciences, Vol 2, No 1 (2017), Pagination: 16-21Abstract
Cleaning validation is one of the key elements of the validation program of an active pharmaceutical ingredient (API) manufacturer. One of the most important aspects of cleaning validation is the sampling methods. Swabbing or surface sampling is the subject of this article. The application of sequential experimental designs for the efficient development of a swab sampling method, based on a fractional factorial design followed by full factorial design, is illustrated in this article.Keywords
Cleaning Validation, Design of Experiments, Hptlc, Swab Sampling.Full Text
References
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- Cooper DW. Using swabs for cleaning validation: excerpt from cleaning validation. Royal Palm Beach, Florida: Institute of Validation Technology; 1997. p. 1–6.
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- Attimarad M, Ahmed KKM, Aldhubaib BE, Harsha S.High-performance thin layer chromatography: A powerful analytical technique in pharmaceutical drug discovery.Pharmaceutical Methods. 2011; 2(2):71–5.
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- Montgomery DC. Design and Analysis of Experiments. 8th ed. New York: John Wiley & Sons; 2012.