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Parameter estimation for roller compaction process using an instrumented vector TF mini roller compactor.
Reddy, Jay Poorna; Phanse, Rahul; Nesarikar, Vishwas.
Afiliação
  • Reddy JP; Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
  • Phanse R; Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
  • Nesarikar V; Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Pharm Dev Technol ; 24(10): 1250-1257, 2019 Dec.
Article em En | MEDLINE | ID: mdl-31437082
ABSTRACT
Using instrumented roll technology, statistical models relating process parameters such as hydraulic pressure, roll speed and screw speed of Vector TF mini roller compactor to ribbon normal stress and density were developed for placebo blends. Normal stress was found to be directly proportional to hydraulic pressure, roll speed and inversely to screw to roll speed ratio. A power-law relationship between ribbon density and normal stress was observed for placebo blends. Models developed for placebo were found to predict ribbon densities of active blends with good accuracy. Standard optimization of roller compaction process parameters involves the investment of a large amount of time and active ingredient. These models can, therefore, be utilized to predict starting instrument settings required to generate a ribbon of desired solid fraction during early-stage development where material availability & time is limited.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Placebos / Modelos Estatísticos / Composição de Medicamentos Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Pharm Dev Technol Assunto da revista: FARMACIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Placebos / Modelos Estatísticos / Composição de Medicamentos Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Idioma: En Revista: Pharm Dev Technol Assunto da revista: FARMACIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos