Bioequivalence Study of Azelnidipine 16 Mg Tablet to Evaluate Pharmacokinetic Profile of Single Dose in Healthy, Adult, Human Volunteers Under Fasting Condition

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Objective: Liposomes are the controlled-release dosage form that improves the therapeutic efficacy of the drugs, prolongs the duration of action, reduces dosage frequency, and improves patient compliance. Methods: The thin-film hydration method was used to prepare Paclitaxel liposomes. In this process, cholesterol and sodium deoxycholate were used for the formulation, while chloroform and methanol were used as diluents. Percentage (%) drug release study was carried out in phosphate buffer at pH 7.4 in USP apparatus II (Paddle type)Model no VDA-8D, Veego, Mumbai, India. Results: Paclitaxel liposomes of various batches showed a percentage yield ranging from 38 to 84%. It was observed that (Encapsulation efficiency)EE% of Batches B1 to B10 were 0,62.33,59.51,50.21,44.30,82.25,88.95,72.34,77.37 and 70.63 percentage, respectively. Data fitting to the Peppas, Higuchi, 1st-order, and zero-order models was used to examine the optimized liposome (B7) release kinetic mechanism. Data comparison was done using the correlation coefficient (R2). Zero-order had an observed correlation coefficient (R2) of 0.9988, which was greater than that for other models. Therefore, it was clear that the medication was released from the formulation after the zero-order release. Conclusion: The prepared liposomes were subjected to various evaluation parameters like SEM, zeta potential, particle size analysis, drug release study, etc. Data showed that an increased concentration of cholesterol increases the drug release from liposomes. Microscopic images of the B7 batch revealed that liposomes are spherical and have regular surfaces. Formulation B7 shows good results and can be considered an optimized batch that has been selected for further cell line studies. The statistical analysis was used to support the improved formulation.

Section: Discussionmentioning

confidence: 99%

A Strategic Process Development and in Vitro Cytotoxicity Analysis of Paclitaxel-Loaded Liposomes

Bose¹,

De²,

Samajdar³

et al. 2023

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“…Metformin and sitagliptin method validation in human plasma was carried out in accordance with USFDA and EMA criteria. Selectivity, sensitivity, matrix effect, linearity, precision and accuracy, recovery, and stability were tested [23][24][25][26].…”

Section: Methods Validationmentioning

confidence: 99%

“…The dried extract was then reconstituted in 500 µl of diluents acetonitrile (ACN): Milli-Q Water (50:50), transported to an autosampler vial for LC-MS/MS analysis, and 10 µl of volume was injected. [25][26][27]…”

Section: Plasma Extraction Was Performed By Liquid-liquid Extraction ...mentioning

confidence: 99%

Determination of Metformin and Sitagliptin in Healthy Human Volunteers' Blood Plasma and Its Bioequivalence Study Under Fasting Condition

Das¹,

Halder

Bose³

et al. 2022

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Objective: Metformin hydrochloride and sitagliptin are the oral anti-hyperglycemic medications used to treat type 2 diabetes and are used in combination to treat patients. In this work, we have developed a bioanalytical method for simultaneous estimation of both the drugs form some formulation and subsequently the validation of the developed method metformin and sitagliptin in human plasma. Methods: The stability studies were done as per USFDA and EMA guidelines. The sample extraction approach presented here was a straightforward liquid extraction. The linearity range of metformin was 11.72 ng/ml to 3000 ng/ml, and sitagliptin was 4.68 ng/ml. to 1200 ng/ml. For metformin, the LOD was 1.0 ng/ml, and LLOQ was 11.72 ng/ml. and for sitagliptin, the LOD was 0.75 ng/ml, and LLOQ was 4.68 ng/ml. LC-ESI-MS/MS was used to develop and validate this method using the Phenomenex Kinetex C18 column. Milli-Q water containing 10 mmol Ammonium Acetate (pH =3.6) and Acetonitrile containing 0.1% Formic Acid (pH =2.4) as solvent systems for the estimation of Sitagliptin in a single dose. Metoprolol is used as an Internal Standard. Results: The total chromatographic run time was only 7.0 min, and the elute time of metformin and sitagliptin was 3.94 min and 3.97 min, respectively. Relative Bioavailability was found at 101.14% for Metformin and 96.96% for Sitagliptin. The overall results show that the Cmax, AUC0-t, and AUC0-∞ for metformin and sitagliptin were within the acceptable limit of 80%-125%. Conclusion: This bioanalytical method was successfully applied in the bioequivalence study. The study design was a randomized, open-label, two treatment, two-period, two sequences, single-dose, crossover bioequivalence study under fasting conditions.

“…The accurate forecast was likewise determined by a fold error of less than two. In other research, a stricter technique known as the average bioequivalence criterion (90% confidence interval within 80-125%) was also used [79,80]. It is important to note that the intended usage and regulatory implications should strongly influence the scope of model validation and verification.…”

Section: Verification Of Modelmentioning

confidence: 99%

Virtual Bioequivalence in Pharmaceuticals: Current Status and Future Prospects

C.,

H.,

K. K.

2023

Virtual bioequivalence studies (VBE) can assess the similarity and potential differences in pharmacokinetic and clinical performance between test and reference formulations based on the translational relationship between in vitro, in silico, and in vivo. The crucial data from clinical trials can be delivered with the help of virtual bioequivalence research, which will speed up the creation of novel and generic medications. Virtual bioequivalence study regulation, however, has not yet reached its complete development. The current status of VBE studies in the market is booming and many pharmaceutical industries have started adapting to its benefits in submitting bioequivalence results for approval from regulatory bodies. FDA had regulated the guidelines for virtual bioequivalence, which the various regulatory agencies accept for the approval of filing ANDA. The importance of implementing VBE has benefited at present in saving cost and time; low workforce and failures can be neglected. Determining the framework for virtual bioequivalence studies for all medications and discussing the potential uses of virtual bioequivalence in the future to support the waiver and optimization of in vivo clinical trials are the main objectives of this review article.