Refine your search
Collections
Year
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Parra, Mario González-de la
- Application of Sequential Design of Experiments to Develop Ibuprofen (400 mg) Tablets by Direct Compression
Abstract Views :469 |
PDF Views:219
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.References
- Bushra R, Aslam N. An overview of clinical pharmacology of ibuprofen. Oman Medical Journal. 2010; 25(3):154–61.Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3191627/
- Rasenack N, Müller BW. Ibuprofen crystal with optimized properties. International Journal of Pharmaceutics.2002; 245(1-2):9–24. doi: 10.1016/S0378-5173(02)002946. Available from: https://www.ncbi.nlm.nih.gov/ pubmed/12270238
- Jivraj M, Martini LG, Thomson CM. An overview of different excipients useful for the direct compression of tablets.Pharm Sci Technol. 2000; 3(2):58–63. Available from: https://www.ncbi.nlm.nih.gov/pubmed/10664574
- Hwang R, Kowalski DL. Design of experiments for formulation development pharmaceutical technology. 2005; S(7).Available from: http://www.pharmtech.com/design-experimentsformulation-development-0
- Hoerl RW, Snee RD. Guiding beacon: Using statisitical engineering principles for problem solving. Quality Progress. 2015 Jun; 52–4. Available from: http://asq.org/quality-progress/ 2015/06/statistics-roundtable/guiding-beacon.html
- Snee RD, Marquardt DW. Screening concepts and designs for experiments with mixtures. Technometrics. 1976; 18(1): 19–29. doi: 10.2307/1267912. Available from: http://amstat.
- tandfonline.com/doi/abs/10.1080/00401706.1976.1048939 6
- Box GEP, Wilson KB. On the experimental attainment of optimum conditions. Journal of the Royal Statistical Society.
- ; Series B(13):1–45. Available from: https://www.jstor.org/stable/2983966?seq=1#page_scan_tab_contents
- Myers RH, Montgomery DC, Andeson-Cook CM. Response surface methodology: Process and product optimization using design of experiments. 4th ed. New York: John Wiley & Sons; 2016. Available from: http://www.wiley.com/ WileyCDA/WileyTitle/productCd-1118916018.html
- Piepel GF, Cornell JA. Mixture experiment approaches: Examples, discussion and recommendations. Journal of Quality Technology. 1994; 26:177–96.
- Snee RD, Hoerl RW. Strategies for formulation development: A step-by-step guide using JMP. North Carolina: SAS Institute; 2016. Available from: https://www.sas.com/store/ books/categories/usage-and-reference/jmp-essentials-anillustratedstep-by-step-guide-for-new-users-second-edition/ prodBK_66709_en.html#
- Application of Design of Experiments (DOE) to the Development and Validation of a Swab Sampling Method for Cleaning Validation
Abstract Views :455 |
PDF Views:209
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.References
- Active Pharmaceutical Ingredients Committee (APIC).Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants. Brussels: CEFIC; 2014. Available from: http://apic.cefic.org/pub/APIC_Cleaning_Validation_ 2014.pdf
- Food and Drug Administration. Validation of cleaning processes (7/93) guide to inspections validation of cleaning processes. Rockville, MD: U.S. Food and Drug Administration; 1993. Available from: http://www.fda.gov/ICECI/ Inspections/InspectionGuides/ucm074922.htm
- Cooper DW. Using swabs for cleaning validation: excerpt from cleaning validation. Royal Palm Beach, Florida: Institute of Validation Technology; 1997. p. 1–6.
- Veit E. Use of statistics to increase validation efficiency.Journal of Validation Technology. 1996; 2(3):207–14.
- Torbeck LD, Branning RC. Designed experiments-A vital role in validation. Pharmaceutical Technology. 1996; 20:108–14.
- Chow SP, Liu JP. Statistical design and analysis in pharmaceutical science: validation, process controls and stability.1st ed. New York: Macel Dekker; 1995. Statistics: textbooks and monographs.
- 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.
- Hall WE. Cleaning for bulk pharmaceutical chemicals (BPCs). In: Harpaz D, Berry IR, editors. Validation of bulk pharmaceutical chemicals. Chicago, Illinois: Interpharm Press; 1997.
- STATISTICA® version 6.1 [Internet]. Tulsa, OK: StatSoft; Available from: http//www.statsoft.com.
- Montgomery DC. Design and Analysis of Experiments. 8th ed. New York: John Wiley & Sons; 2012.