Abstract
Purpose: The aim of this study was to evaluate the influence of the geometric shape on the dissolution rate of the domperidone, a drug model for immediate release dosage form. In this regard, a lack of sufficient information about the effective dissolution rate of the drugs regarding their shapes has made this issue an interesting subject for researchers. Methods: For this purpose, three tablet shapes, namely flat and biconvex both in a round and oblong shapes, with different four sizes were modelled for the preparation of domperidone tablet. In vitro dissolution test was accomplished using a USP dissolution apparatus II. The drug dissolution rate was assessed by calculating various dissolution parameters; e.g., dissolution efficiency (DE), mean dissolution rate (MDR), mean dissolution time (MDT), and difference and similarity factors (f1 and f2 ). Results: Regarding the disintegration time, the larger tablets showed a faster disintegration time. When the size of the tablets was smaller, the amount of released drug was significantly decreased. In addition, #9 tablets with a flat or biconvex geometry had obvious effects on the DE values. Generally, biconvex tablets had higher DE percentage than the flat tablets. Conclusion: Noticeable differences in dissolution parameters by considering the different geometric shapes play an important role in the drug release kinetics which makes a significant effect on quick onset of action in oral administration.
Highlights
Dissolution rate studies play a key role in the development of pharmaceutical dosage forms, in vitro and in vivo correlation (IVIVC) assessment,[1] registration, and quality control of various dosage forms.[2]
The aim of this study was to evaluate the influence of the geometric shape on the dissolution rate of the domperidone, a drug model for immediate release dosage form
The drug dissolution rate was assessed by calculating various dissolution parameters; e.g., dissolution efficiency (DE), mean dissolution rate (MDR), mean dissolution time (MDT), and difference and similarity factors (f1 and f2)
Summary
Dissolution rate studies play a key role in the development of pharmaceutical dosage forms, in vitro and in vivo correlation (IVIVC) assessment,[1] registration, and quality control of various dosage forms.[2] The dissolution methods for individual drugs are determined by the solubility of the active substance,[3] the dosage form characteristics,[4] and the intended route of administration such as oral solid dosage form. Domperidone, a drug model for immediate release dosage form was selected according to its biopharmaceutical classification system that classified to class II, suggesting that the release of these type of drugs from dosage forms is controlled by formulation composition.[15] we can study and evaluate dissolution manner related to various tablet shapes. In addition as the novelty of the study, the results of this project will be able to guide pharmaceutical industry formulators to simulate the drug release pattern of generic formulations or adjust it according to the pharmacopoeia requirements
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