Application of melt granulation technology to enhance tabletting properties of poorly compactible high-dose drugs.
J Pharm Sci
; 100(4): 1553-65, 2011 Apr.
Article
em En
| MEDLINE
| ID: mdl-24081475
ABSTRACT
Using metformin HCl as the model drug and hydroxypropylcellulose (HPC) as the polymeric excipient, a melt granulation (MG) process that employs a twin-screw extruder has been developed to enhance compactibility of poorly compactible high-dose drug substances. A high (90%) drug-load tablet formulation, containing 1025 mg of active pharmaceutical ingredients and 109 mg of excipients, was produced. Drug-polymer-powder mixtures were melt granulated at a temperature above glass transition of HPC (130°C) but below melting point of metformin HCl (224°C). MG was compared with modified wet granulation (WG) and solvent granulation (SG) processes. Under identical compression force, the hardness of tablets produced was MG>SG>WG and the friability was MGPalavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Comprimidos
/
Celulose
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Composição de Medicamentos
/
Excipientes
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Hipoglicemiantes
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Metformina
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
2011
Tipo de documento:
Article