Refinement of Lower Acceptance Value of the Similarity Factor f2 inComparison of Dissolution Profiles

Gohel, Mukesh C.; Panchal, Maulik

doi:10.14227/dt090102p18

Cited by 11 publications

(7 citation statements)

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“…The similarity factor f2 is defined as a logarithmic reciprocal square root transformation of one plus the mean squared (the average sum of squares) differences of drug percent dissolution between test and standard products. 25,26 …”

Section: Discussionmentioning

confidence: 99%

Evaluation of Merremiatridentata Mucilage as Binding Agent Intablet Dosage Forms

2017

Rasayan J Chem

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An increasing interest in the use of natural polymers or gums in pharmaceutical formulations focusing the tremendous orientation to discover and extract such gums. The pharmaceutical industry is ever thirsty to satisfy patient's therapeutic needs by utilizing inactive excipients along with active ingredients in formulation development. Binders are added to tablet formulations to add cohesiveness to powders thereby providing the necessary bonding to form granules which under compaction form a compact mass as tablet. Binders are also essential to achieve the hardness of the tablet. The development of new excipients for potential use as binding agent in tablet formulations continues to be of interest. The present paper consisted of the evaluation of mucilage of Merrimia tridentata roots for its binding property in solid dosage forms by using starch as a standard binder. Ibuprofen was used as a model drug and tablets were prepared using mucilage obtained from roots of Merremia tridentate as a test binder and starch as standard binder by wet granulation method. The granules were evaluated for flow properties, drugexcipient compatibility and compressibility index and tablets were evaluated for weight variation, hardness, friability, disintegration time and dissolution rate. The similarity factor was determined for comparison of dissolution profiles of test and standard tablets. It has been found from the present study that the roots of plant Merremia tridentata has a good mucilage content which may be taken as a good natural source of mucilage for better binding properties with comparable flow properties, disintegration time, hardness and release rate similar to starch.

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Section: Discussionmentioning

confidence: 99%

Evaluation of Merremiatridentata Mucilage as Binding Agent Intablet Dosage Forms

2017

Rasayan J Chem

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“…It was therefore decided to adopt a ± 10% deviation at all sampling times. [9] According to the limits for drug dissolution at 1, 2, 6, and 12 h is 21.64-26.45%, 27.86-34.05%, 52.71-64.43%, and 90-110%, respectively. The midpoint values, shown in Table 3, shall be considered as the most desirable dissolution pattern.…”

Section: Ideal Dissolution Profilementioning

confidence: 99%

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Hiral

2017

AJP

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Introduction:The main objective of this study was to amalgamate quality by design (QbD) concept to develop oxcarbazepine modified release granules with pre-designed qualities. Materials and Methods: Modified release granules of oxcarbazepine were prepared using three different waxes. In this study, modified drug release was considered as quality targeted product profile; drug release at 2, 6, and 12 h was selected as critical quality attributes, type of wax and amount of wax were the critical material attributes. Results and Discussion: As per QbD, 3 2 full factorial batches were evaluated for effect on drug release at different time points. The optimized formulation was subjected to X-ray diffraction (XRD) study. The results of XRD showed that the crystal form of the drug remained unaltered after the melt granulation process. The robustness of the optimized formulation was checked by dissolution study considering different pH of dissolution medium, using hydroalcoholic medium and by simulating condition after meal. Based on the in vitro drug dissolution studies in different media, modified drug release is expected from the formulation. The dissolution studies in simulated dissolution media showed insignificance effect of food and combined food and alcohol on drug release. The convolution derived plasma concentration time profile indicated sustained release from modified release granules. From the result, design space was generated, and after implementation of control strategy, the risk factors were below critical level. Conclusion:The use of QbD and convolution approach makes it possible to develop formulation with desired qualities in short time.

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“…12 In place of 10 as the absolute percentage difference between R and T,we proposed the use of 10% of percentage of drug dissolved from reference product as allowable deviation in the dissolution results of a test product. To consider variability between samples with more specificity,the optional weight (w) was calculated by taking the ratio of the absolute difference of mean percentage drug dissolved between R and T to 10% of percentage of drug dissolved from the reference formulation at each timepoint.…”

Section: Approachmentioning

confidence: 99%