Assessment of the possibility of using comparative in vitro dissolution kinetics (biowaiver) instead of in vivo bioequivalence evaluation for establishing the interchanbeability of generic drugs

Шохин, И. Е.; Ramenskaya, G. V.; Василенко, Г. Ф.; Malalshenko, E. A.

doi:10.1007/s11094-011-0570-6

Cited by 9 publications

(4 citation statements)

References 2 publications

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“…The best way to ensure an adequate in vivo performance of a generic formulation is to conduct a bioequivalence study in humans. However, in vitro dissolution studies can contribute to establishing the interchangeability of generic formulations [2]. Recently, some authors have been concerned about the safe interchangeability between reference products and their generic counterparts or even among generic formulations [3,4].…”

Section: Introductionmentioning

confidence: 99%

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Medina

Aguilar

Hurtado

2017

Int J Pharm Pharm Sci

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Objective: To characterize the dissolution behaviour of carbamazepine generic suspensions using the USP Dissolution Apparatus 2 and the flow-through cell method with simulated gastrointestinal fluids as dissolution media.Methods: Tegretol® suspension and two generic formulations were tested. Dissolution studies were performed using the USP Apparatus 2 (75 rpm and 900 ml of dissolution medium) and the flow-through cell method (laminar flow at 16 ml/min). Simulated gastric fluid (SGF) (with and without pepsin) and simulated intestinal fluid (SIF) (without pancreatin) at 37.0±0.5 °C, was used as dissolution media. The quantity of dissolved carbamazepine was determined at 5 min intervals until reaching 60 min, at 285 nm. Percentage dissolved at 60 min, mean dissolution time, dissolution efficiency values (model-independent parameters), as well as t50% and t63.2% were calculated (model-dependent parameters). Values for all parameters were compared between the reference and generic formulations using one-way analysis of variance (ANOVA) following a Dunnett’s multiple comparison test. Dissolution data were also fitted to different fit models.Results: Since the first sampling time, the reference product had reached 100% of drug dissolved, which was determined using USP Apparatus 2. Nevertheless, significant differences in the three model-independent parameters of generic products were found (*P<0.05). Dissolution data obtained with the paddle apparatus were fitted to different kinetic equations; however, using the flow-through cell method and SIF without pancreatin, the three drug products were fitted to the same kinetic model (Gompertz). With ANOVA-based comparisons and the flow-through cell method, significant differences were found in dissolution data of generic product A versus reference at all sampling times (*P<0.05). The flow-through cell method and SGF with pepsin were the best options to discriminate among dissolution profiles.Conclusion: The flow-through cell method seems to be an adequate dissolution apparatus to characterize in vitrodissolution performance of Class II drugs manufactured as suspensions. For carbamazepine suspensions, SGF and laminar flow at 16 ml/min were the most appropriate conditions to discriminate among generic formulations. Given the physicochemical characteristics of carbamazepine and the environment in which the drug products were tested, these differences could be of clinical relevance.

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Section: Introductionmentioning

confidence: 99%

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Medina

Aguilar

Hurtado

2017

Int J Pharm Pharm Sci

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“…The dissolution of the drug from oral solid dosage forms is necessary for drug bioavailability, especially for sparingly water soluble drugs such as paracetamol. For this reason, dissolution studies can give an idea of the amount of drug available for absorption after oral administration [14][15][16]. Drugs with poor dissolution profiles will not be sufficiently available in the body system to produce the desired therapeutic response [17,18].…”

Section: Discussionmentioning

confidence: 99%

Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?

Zaid¹,

Rinno²,

Jaradat³

et al. 2013

East Mediterr Health J

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The objective of this study was to evaluate the quality of 10 commercial paracetamol products available on the Palestinian market. We carried out a survey on the price of all paracetamol tablet products and assessed their quality. To assess quality, all products were examined visually for their organoleptic properties, tested for weight uniformity, friability, disintegration, and dissolution profile, and assayed for paracetamol content. All imported products were 2 to 3 times more expensive than the locally produced generic products. Based on our testing procedure, all paracetamol products were equivalent to the innovator product except for 1 imported product which fell below the approved specifications developed for the innovator product. Although the majority of generic products met the dissolution specification requirement that 80% of the drug must dissolve in 30 minutes, 1 generic product failed. These results demonstrate that generic paracetamol tablets produced by local manufacturers are often comparable in vitro to the innovator product and have lower costs.

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“…Therefore, it is essential to test the interchangeability of the marketed generic products using a suitable approach. The interchangeability of generics is understood to mean the possibility for their mutual replacement or replacement of the original drug in clinical practice 5 . Bioequivalence studies is considered to be costly , time consuming and involve subjecting healthy volunteers to risks of side effects 6 .…”

mentioning

confidence: 99%

A comparative study on vildagliptin brand and its generic equivalents using dissolution test as quality control measure tool

Altoum,

AL-Enazi,

Abudahash

et al. 2024

Sci Rep

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Market drugs including brand or generic with poor quality, don’t meet the acceptable standard guidelines. Vildagliptin is an important antidiabetic drugs used in monotherapy or in combinations protocols for treatment of diabetes mellites. The main goal of the current study is to assess the pharmaceutical equivalence of two marketed generics of vildagliptin 50 mg tablets compared to the branded product (Galvus 50 mg). The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drug. The results revealed that all tested samples showed dissolution behavior like standard drug. Whole samples dissolution reached after 15 min in accordance with the standard. According to the similarity factors records, tested vildagliptin samples showed a comparable dissolution to the reference drug. The current work presents an in vitro protocol for quality evaluation of recently released generic drugs.

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Assessment of the possibility of using comparative in vitro dissolution kinetics (biowaiver) instead of in vivo bioequivalence evaluation for establishing the interchanbeability of generic drugs

Cited by 9 publications

References 2 publications

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?

A comparative study on vildagliptin brand and its generic equivalents using dissolution test as quality control measure tool

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