Even the formulation method direct compression can be selected considering the physical characteristics of omeprazole magnesium and the excipients used. Join me on Linkedin. Home Journals About Us. The flowability and compressibility of omeprazole magnesium powder indicate that the powder is suitable for both direct compression and wet granulation method depending on the other excipients used with their respective amounts that could be used instead.
However water aerosil which was mixed with omeprazole magnesium showed physical changes, that is, colour changes, when subjected to all conditions showing some incompatibility with omeprazole magnesium powder. Preformulation is the first step in the rational formulation of an active pharmaceutical ingredient API.
Migoha would like to express his sincere appreciation to Tanzania Food and Drugs Authority TFDA for financial support for this study and also The School of Pharmacy for providing required facility to carry out this research work. Additionally the assay was performed as per monograph for determination of omeprazole magnesium USP30NF35 [ 3 ].
Newer Post Older Post Home. The mixtures were filled in closed vials and placed in stability chambers in the conditions as prescribed in US Pharmacopeia 30NF25 [ 4 ]. Table of Contents Alerts. Journal of Pharmaceutical Sciences.
Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets
The sample of the mixtures was mixed with API and excipients as prescribed in the study proposal. BoxDar es Salaam, Tanzania. Omeprazole, 5-methoxy-2 4-methoxy-3,5-dimethylpyridinyl methyl sulfinyl -1H-benzimidazole, is a potent inhibitor of gastric acid secretion [ 2 ]; see Figure 1. Avicel PHomeprazole Mg: Review of clinical experience in acid disorders: The values of moisture content obtained by using loss on drying method indicate that the amount of moisture present in all the samples subjected to all three different storage conditions was not constant and the variation did not follow any specific trend as days progressed.
Abstract Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient API.
The reference spectrum day 0 spectrum was found in between other spectra in the near infrared region. That is, it is recommended that about 0. Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient API. Helping them with websites on Chemistry. This change of nature was not observed in samples kept in the room temperature. The main aim of sieve analysis was to determine the distribution of different size of drug particles present [ 8 ].
Join me on twitter. Drug excipient compatibility studies were carried out by mixing drug with potential excipient. Introduction Preformulation is the first step in the rational formulation of an active pharmaceutical ingredient API.