Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets

Migoha, Christopher Oswald; Ratansi, M.; Kaale, Eliangiringa; Kagashe, Godliver

doi:10.1155/2015/307032

Cited by 9 publications

(6 citation statements)

References 3 publications

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“…The drug was thoroughly mixed with excipients in a ratio of 1:1, and all the samples were stored at 40°C and 75% RH in closed vials for 21 days and then scanned by FTIR. The spectra of pure drugs and mixtures of drugs with excipients were compared with standards to check for any physical and chemical incompatibility 20,21 .…”

Section: Methodsmentioning

confidence: 99%

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2023

IJPSR

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The present research work was to formulate optimize and evaluate hydrocortisone-loaded niosomal gel for the management of rheumatoid arthritis. Method: Niosomal gel was successfully prepared by lipid-thin film hydration process and optimized by using 2 3 full factorial designs using three independent variables (tween 80 concentration, cholesterol concentration, and sonication time) and three dependent variables (cumulative drug release, mean particle size and entrapment efficiency). The effect of all variables was assessed by response surface methodology. Results: The prepared formulations were evaluated in terms of particle size, in-vitro drug release, encapsulation efficiency, zeta potential, viscosity, and spreadability. Based on response surface methodology, S6 formulation was found to be the best formulation with entrapment efficiency of 92.27%, in-vitro drug release of 75.61% in 8 hrs, and mean particle diameter of 121.58 nm. The stability studies indicated that all the formulations are stable as none exhibited significant drug content change over time. Conclusion: The study indicated the successful development of hydrocortisone-loaded niosomal gels with improved penetration, good homogeneity, and enhancement of duration of action. It can thus be concluded that the developed gel could be an effective treatment for rheumatoid arthritis. INTRODUCTION:Hydrocortisone acetate belongs to the class of corticosteroids, which is a synthetic or semi-synthetic derivative of the natural hormone cortisol secreted by adrenal cortex 1, 2 . FDA approved it in 1952 for clinical use in managing inflammatory diseases like rheumatoid arthritis, psoriasis, asthma, eczema, and many more 3, 4 . The conventional therapy with hydrocortiosone is based on systemic delivery by different routes, which leads to serious complications 5-7 .

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Section: Methodsmentioning

confidence: 99%

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2023

IJPSR

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“…During the compounding of the tablet, the compatibility of the excipients with the API needs to be carefully considered. Migoha et al [ 263 ] showed that omeprazole can interact with components of the tablet mass. In preformulation studies, they observed that omeprazole interacted with Aerosil 200 (colloidal silica), turning dark purple or dark brown, depending on the test conditions.…”

Section: Development Of New Formulations With Ppismentioning

confidence: 99%

“…In preformulation studies, they observed that omeprazole interacted with Aerosil 200 (colloidal silica), turning dark purple or dark brown, depending on the test conditions. For other excipients, such as sodium lauryl sulfate, Avicel PH 101, magnesium stearate, lactose, and starch, no change was identified [ 263 ].…”

Section: Development Of New Formulations With Ppismentioning

confidence: 99%

Formulation of Dosage Forms with Proton Pump Inhibitors: State of the Art, Challenges and Future Perspectives

2022

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Since their introduction to pharmacotherapy, proton pump inhibitors (PPIs) have been widely used in the treatment of numerous diseases manifested by excessive secretion of gastric acid. Despite that, there are still unmet needs regarding their availability for patients of all age groups. Their poor stability hinders the development of formulations in which dose can be easily adjusted. The aim of this review is to describe the discovery and development of PPIs, discuss formulation issues, and present the contemporary solutions, possibilities, and challenges in formulation development. The review outlines the physicochemical characteristics of PPIs, connects them with pharmacokinetic and pharmacodynamic properties, and describes the stability of PPIs, including the identification of the most important factors affecting them. Moreover, the possibilities for qualitative and quantitative analysis of PPIs are briefly depicted. This review also characterizes commercial preparations with PPIs available in the US and EU. The major part of the review is focused on the presentation of the state of the art in the development of novel formulations with PPIs covering various approaches employed in this process: nanoparticles, microparticles, minitablets, pellets, bilayer, floating, and mucoadhesive tablets, as well as parenteral, transdermal, and rectal preparations. It also anticipates further possibilities in the development of PPIs dosage forms. It is especially addressed to the researchers developing new formulations containing PPIs, since it covers the most important formulary issues that need to be considered before a decision on the selection of the formula is made. It may help in avoiding unnecessary efforts in this process and choosing the best approach. The review also presents an up-to-date database of publications focused on the pharmaceutical technology of formulations with PPIs.

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“…Briefly, 10 mg drug was mixed with 20 ml of octanol and water in a separating funnel and shaken for about half an hour. The separating funnel was kept for 24 h and concentration of solute was measured in each solvent using UVspectrophotometer (UV 3000+, Lab India Instruments, Mumbai, India) at 290 nm [11], [12] .…”

Section: Determination Of Partition Coefficientmentioning

confidence: 99%

Optimization and evaluation of immediate release pantoprazole sodium sesquihydrate capsule by buffered macro environment method

Khulbe¹,

Singh²,

Riyal³

et al. 2019

IJRAT

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Pantoprazole sodium inhibits gastric acid secretion through permanent prevention of (H+/K+)-ATPase function in gastric parietal cell. In case of immediate relief from ulcer and related gastrointestinal complications it is necessary to release the drug immediately. But, immediate release of proton pump inhibitors such as pentoprozole causes their degradation in gastric medium due to their acid labile nature. Due to this reason pantoprazole is available in the form of enteric coated tablets. The best approach for increasing drug stability in acidic medium is the incorporation of buffer in formulation. Macro-environment buffering method was used in which the whole gastric fluid is buffered by buffering agents. Pantoprazole immediate release granules were prepared by wet granulation method. Sodium starch glycolate and cross carmellose sodium were used as superdisintegarnts. Optimization of the formulation was done by using 2 3 factorial design on formulation P-8. Amount of sodium starch glycolate (10% and 12%) (X 1 ), amount of PVPK-30 (3.5% and 5%) (X 2 ) and amount of mannitol (45% and 50%) were used as independent variable. Coded values for 2 levels were -1 and +1. Ex vivo permeation study was performed in selected optimized batch using non-everted intestinal sac. The results showed 98.86% release after 30 min. The performance of optimized formulation was compared to the marketed formulation (Pantocid 20mg tablet: Sun Pharmaceutical Industries Ltd.). This article mainly concluded that the macro environmental buffering method can be used for the immediate release of acid labile drug.

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Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets

Cited by 9 publications

References 3 publications

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Formulation of Dosage Forms with Proton Pump Inhibitors: State of the Art, Challenges and Future Perspectives

Optimization and evaluation of immediate release pantoprazole sodium sesquihydrate capsule by buffered macro environment method

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