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1.
Eur J Pharm Sci ; 48(4-5): 680-8, 2013 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-23313622

RESUMO

Continuous manufacturing methods offer economic and quality advantages when compared with batch manufacturing methods. In continuous manufacturing, one requires real time assurance of quality of product via the implementation of PAT tools. This study focuses on an in-line near-infrared (NIR) spectroscopic method for determining the drug content of powder mixtures and tablets during a continuous tableting process. Tablets consisting of acetaminophen (20-30%), lactose (69.07-78.93%) and magnesium stearate (0.93-1.07%) were prepared in a continuous direct compression line that consisted of two loss-in-weight feeders, one for acetaminophen and one for premixed lactose and magnesium stearate, and a continuous mixer followed by a rotary tablet press. NIR spectroscopy was applied to the continuous mixer and tablet press to perform a 100% product check at full tableting speed. The UV-spectrophotometric method was used as an off-line reference method to determine the acetaminophen content in the samples. The powder mixture and tablet samples were taken during the process for the calibration of continuous mixer and tablet press, respectively. For the continuous mixer, model creation with the PLS method yielded R-Square and RMSEC (root mean square error of calibration) values of 0.975% and 0.56%, respectively. For the tablet press, the corresponding R-Square and RMSEC values were 0.943% and 0.75%, respectively. A test run demonstrated good predictability in the estimation of the API content in the powder mixtures and tablets during the continuous tableting process. For the continuous mixer and tablet press, the RMSEP (root mean square error of prediction) values were 0.96% and 1.37%, respectively. This study demonstrates that an NIR instrument capable of fast spectra acquisition can be a valuable tool for the in-line monitoring of the continuous mixing and tableting processes.


Assuntos
Composição de Medicamentos/métodos , Pós/química , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Comprimidos/química , Acetaminofen/análise , Lactose/análise , Ácidos Esteáricos/análise
2.
Drug Dev Ind Pharm ; 39(11): 1802-8, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23163644

RESUMO

CONTEXT: Continuous processing is becoming popular in the pharmaceutical industry for its cost and quality advantages. OBJECTIVE: This study evaluated the mechanical properties, uniformity of dosage units and drug release from the tablets prepared by continuous direct compression process. MATERIALS AND METHODS: The tablet formulations consisted of acetaminophen (3-30% (w/w)) pre-blended with 0.25% (w/w) colloidal silicon dioxide, microcrystalline cellulose (69-96% (w/w)) and magnesium stearate (1% (w/w)). The continuous tableting line consisted of three loss-in-weight feeders and a convective continuous mixer and a rotary tablet press. The process continued for 8 min and steady state was reached within 5 min. The effects of acetaminophen content, impeller rotation rate (39-254 rpm) and total feed rate (15 and 20 kg/h) on tablet properties were examined. RESULTS AND DISCUSSION: All the tablets complied with the friability requirements of European Pharmacopoeia and rapidly released acetaminophen. However, the relative standard deviation of acetaminophen content (10% (w/w)) increased with an increase in impeller rotation rate at a constant total feed rate (20 kg/h). A compression force of 12 kN tended to result in greater tablet hardness and subsequently a slower initial acetaminophen release from tablets when compared with those made with the compression force of about 8 kN. CONCLUSIONS: In conclusion, tablets could be successfully prepared by a continuous direct compression process and process conditions affected to some extent tablet properties.


Assuntos
Acetaminofen/química , Analgésicos não Narcóticos/química , Celulose/química , Excipientes/química , Modelos Moleculares , Dióxido de Silício/química , Ácidos Esteáricos/química , Automação , Fenômenos Químicos , Coloides , Composição de Medicamentos , Finlândia , Dureza , Cinética , Fenômenos Mecânicos , Controle de Qualidade , Solubilidade , Comprimidos , Tecnologia Farmacêutica , Resistência à Tração
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