| Popis: |
Aims: The main objective of this work has been the development of delayed-release hard capsule containing mini-tablets of two-platelet antiaggregant, acetylsalicylic acid and clopidogrel, for the treatment of patients suffering from acute coronary syndrome at risk of gastrointestinal bleeding, therefore jointly is administered an inhibitor of gastric acid secretion, the ranitidine. Study Design: Design of mini-tablets into a capsule for the treatment of acute coronary syndrome. Methodology: For the galenic preparation of the three mini-tablets, an in-depth study of the choice of excipients and the most appropriate manufacturing methodology was carried out. Once the suitability of the mixture for use in direct compression was determined, which is the selected technological method, as it is the most profitable and involves less time, the mini-tablets were prepared and their physical characterization. Tablet appearance and physical characteristics such as dimensions, thickness, mass, resistance to crushing, friability, disintegration time and content uniformity met the requirements established according to pharmacopoeia to ensure the quality of the tablets. Results: The final formulation consists of the grouping of mini-tablets of three drugs in a delayed-release hard capsule ("tablets-in-capsule") for the treatment of patients suffering from acute coronary syndrome at risk of gastrointestinal bleeding. All tablets show resistance to crushing, disintegration, and friability features that strictly meet pharmacopoeia requirements. Conclusion: Adherence to treatment is increased because the concomitant administration of three active ingredients is unified in a single pharmaceutical dosage form. |
