Q87407195
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The performance of a pharmaceutical formulation, such as the drug (API) release rate, is significantly influenced by the properties of the materials used, the composition of the final product and the tablet compression process parameters. However, in some cases, the knowledge of these input parameters does not necessarily provide a reliable description or prediction of tablet performance. Therefore, the knowledge of tablet microstructure is desirable to understand such formulations. Commonly used analytical techniques, such as X-ray tomography and intrusion mercury porosimetry, are not widely used in pharmaceutical companies due to their price and/or toxicity, and therefore, efforts are made to develop a tool for fast and easy microstructure description. In this work, we have developed an image-based method for microstructure description and applied it to a model system consisting of ibuprofen and CaHPO4∙2H2O (API and excipient with different deformability). The obtained parameter, the quadratic mean of the equivalent diameter of the non-deformable, brittle excipient CaHPO4∙2H2O, was correlated with tablet composition, compression pressure and API release rate. The obtained results demonstrate the possibility of describing the tablet dissolution performance in the presented model system based on the microstructural parameter, providing a possible model system for compressed solid dosage forms in which a plastic component is present and specific API release is required.
- MeSH
- biologické modely * MeSH
- ibuprofen chemie MeSH
- pomocné látky * chemie MeSH
- příprava léků MeSH
- tablety chemie MeSH
- Publikační typ
- časopisecké články MeSH
Hard gelatin capsules belong to the most commonly used pharmaceutical solid dosage forms but their filling using capsule filling machines is known to present many problems to their operators. Such problems are caused by relatively complicated requirements on rheological properties of capsule fillings which vary with the filling technique used as those techniques rely on different physical principles. This review provides an overview of automated and semi-automated capsule-filling processes, emphasizing the aspects of processed particulate mixture behavior in the process; this description determines the process requirements on rheological properties of capsule fillings. Rheological properties which can be used to study and optimize the filling process are discussed, as well as methods of improving those properties using the flow additives.
- MeSH
- farmakokinetika MeSH
- kongresy jako téma MeSH
- lékové formy MeSH
- lékové interakce MeSH
- Publikační typ
- práce podpořená grantem MeSH
The integrity of film-coated tablets may be a crucial factor for their long-term stability as well as for their desirable action in the digestive tract. Consequently, nondestructive and sensitive tests are very important for quality control of the film-coated tablets. The quasi- stationary permeation of inert gases through the tablets was proposed as a new fast and inexpensive test of the integrity of filmcoated tablets. Using the commercial coating material Opadry® and alternative coating materials, the sensitivity to the test of the coating composition and to local damage of the tablets by mechanical stress was demonstrated.
