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dc.rights.licenseAll rights licenseen_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorde León Laboy, Gisela
dc.date.accessioned2020-08-26T17:14:30Z
dc.date.available2020-08-26T17:14:30Z
dc.date.issued2016
dc.identifier.citationde León Laboy, G. (2016). Manufacture and evaluation of an experimental 37.5 kg scale batch of 0.103% w/w ethinyl estradiol triturate (formulation number WC3074-011) [Unpublished manuscript] Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/508
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractActavis Fajardo, is a Pharmaceutical company dedicated to the manufacturing and packaging of oral contraceptive products. Ethinyl Estradiol is an intermediate product used to incorporate Ethinyl Estradiol active in tablet formulations. Ethinyl Estradiol is a high potency drug; therefore, low dosages are required to achieve its therapeutic range (for example 10µg equivalent to 0.014% of the powder blends of the formulations). The triturate is prepared as an intermediate product to aid in the distribution of the active ingredient in the final blend tablets formulation. The manufacturing process of the intermediate product consists of wet massing and drying cycles in a solid processor. Tablet formulations containing this Ethinyl Estradiol triturate are showing a significant variability in the In Process Content Uniformity Test. Therefore, one of the solution was identified to improve the variability in the In Process Content Uniformity Test is to change the formulation of the Ethinyl Estradiol from a concentration of 0.206% w/w to 0.103% w/w. This report will shows the new formulation, manufacturing process and results obtained for a new Ethinyl Estradiol Triturate with a concentration of 0.103% w/w. Key Terms - Blend Uniformity, Ethinyl Estradiol, Formulation Triturate.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Pueto Ricoen_US
dc.relation.ispartofManufacturig Engineering;
dc.relation.ispartofseriesSpring-2016;
dc.relation.haspartSan Juanen_US
dc.subject.lcshEthinyl estradiol
dc.subject.lcshOral contraceptives
dc.subject.lcshPharmaceutical industry--Quality control
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.titleManufacture and Evaluation of an Experimental 37.5 kg Scale Batch of 0.103% w/w Ethinyl Estradiol Triturate (Formulation Number WC3074-01I)en_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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