Comparative In Vitro Study of Six Carbamazepine Products

Mittapalli, Pavan Kumar; Bandari, Suresh; Hussaini, Shokrullah; Rao, Yi; Apte, S. S.

doi:10.1208/s12249-008-9035-y

Cited by 15 publications

(6 citation statements)

References 16 publications

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“…There are many researches that emphasize the need to evaluate different brands of the same generic drug in order to screen the quality product available in local market 7,[31][32][33] .…”

Section: Discussionmentioning

confidence: 99%

Pharmaceutical Evaluation of Commercial Brands of Cefixime 400MG Capsules Marketed in Karachi (Pakistan)

Shahnaz¹,

Arshad²,

Shyum³

et al. 2009

Journal of Pharmaceutical Research

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The sale and use of substandard drugs is a major health problem in many developing countries where strict drug control legislation does not exist. The study investigates pharmaceutical quality of different brands of cefixime 400mg capsules marketed in Karachi (Pakistan). Compendial standards and government regulations require that all drug products, whether prescription or OTC products, meet strict standards of identity, potency, and purity. Each type of dosage form requires careful study of the physical and chemical properties of drug substances to achieve a stable and effective product. The different brands were subjected to various tests like uniformity of weight, diameter, length, disintegration, dissolution and chemical assays. The susceptibility test of drug was also carried out using agar dilution method along different isolates obtained from health care set ups. All the 6 brands had satisfactory drug content, antimicrobial activity and all passed the USP drug release test. The six brands are physically and chemically equivalent and could be interchanged. The study reinforces the need for constant monitoring of proprietary products of the same generic drugs to ensure quality and consequent efficacy with pharmacoeconomy, which would help in the selection of the most appropriate brand in terms of Pharmacoeconomy and quality.

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“…There are many researches that emphasize the need to evaluate different brands of the same generic drug in order to screen the quality product available in local market 7,[31][32][33] .…”

Section: Discussionmentioning

confidence: 99%

Pharmaceutical Evaluation of Commercial Brands of Cefixime 400MG Capsules Marketed in Karachi (Pakistan)

Shahnaz¹,

Arshad²,

Shyum³

et al. 2009

Journal of Pharmaceutical Research

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“…The dissolution media and method used in this study were selected based on previous reports, indicating its biopredictive ability and previously developed IVIVC. Taking into account the reported values for CBZ solubility (2.96 mg/mL in deionized water containing 1% of SLS [29] and 3.412 ± 0.13 mg/mL in the same media [30]) 900 mL of media does not provide sink conditions for a 400 mg tablet. The maintenance of sink conditions is, in general, required in quality control media, but for IVIVC, non-sink conditions can be of application.…”

Section: Modeling Dissolution Datamentioning

confidence: 99%

In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium

et al. 2020

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The aim of the present study was to bring additional evidence regarding a biopredictive dissolution medium containing 1% sodium lauryl sulphate (SLS) to predict the in vivo behavior of carbamazepine (CBZ) products. Twelve healthy volunteers took one immediate release (IR) dose of either test and reference formulations in a bioequivalence study (BE). Dissolution profiles were carried-out using the medium. Level A in vitro–in vivo correlations (IVIVC) were established using both one-step and two-step approaches as well as exploring the time-scaling approach to account for the differences in dissolution rate in vitro versus in vivo. A detailed step by step calculation was provided to clearly illustrate all the procedures. The results show additional evidence that the medium containing 1% SLS can be classified as a universal biopredictive dissolution tool, and that both of the approaches used to develop the IVIVC (one and two-steps) provide good in vivo predictability. Therefore, this biopredictive medium could be a highly relevant tool in Latin-American countries to ensure and check the quality of their CBZ marketed products for which BE studies were not requested by their regulatory health authorities.

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“…According to the screening matrix, nine formulations were prepared with combination of each disintegrant with volatile materials containing 40% carbamazepine in each 250 mg tablet. To study the extent of influence of each volatile material and disintegrant on disintegration time and tablet friability, plots of main effects were generated using a commercially available statistical software (Minitab V R statistical software; version 17, Minitab Inc., State College, PA) 28 .…”

Section: Screening and Establishment Of Cmasmentioning

confidence: 99%

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine

Mishra

Rohera

2016

Pharmaceutical Development and Technology

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The objective of the present study was to design and develop a formulation for orally disintegrating tablets (ODTs) of carbamazepine using quality by design principles. The target product profile (TPP) and quality target product profile (QTPP) of ODTs were identified. Risk assessment was carried out by leveraging prior knowledge and experience to define the criticality of factors based on their impact by Ishikawa fishbone diagram and preliminary hazard analysis tool. Box-Behnken response surface methodology was used to study the effect of critical factors on various attributes of ODTs. The independent factors selected were compression pressure (X), concentration of sublimating agent (volatile material) (X), disintegrant concentration (X) and the responses were tablet crushing strength, tablet porosity, disintegration time, water absorption time, tablet friability and drug dissolution. ANOVA and lack of fit test illustrated that selected independent variables had significant effect on the response variables, and excellent correlation was observed between actual and predicted values. Optimization by desirability function indicated that compression pressure, X (1534 lbs), ammonium bicarbonate concentration, X (7.68%) and Kollidon CL-SF concentration, X (6%) were optimum to prepare ODT formulation of carbamazepine of desired attributes complying with QTPP. Thus, in the present study, a high level of assurance was established for ODT product quality and performance.

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Comparative In Vitro Study of Six Carbamazepine Products

Cited by 15 publications

References 16 publications

Pharmaceutical Evaluation of Commercial Brands of Cefixime 400MG Capsules Marketed in Karachi (Pakistan)

Pharmaceutical Evaluation of Commercial Brands of Cefixime 400MG Capsules Marketed in Karachi (Pakistan)

In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive Dissolution Medium

An integrated, quality by design (QbD) approach for design, development and optimization of orally disintegrating tablet formulation of carbamazepine

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