Pharmaceutical evaluation of glibenclamide products available in the Jordanian market

El-Sabawi, Dina

doi:10.5897/ajpp2012.0014

Cited by 5 publications

(5 citation statements)

References 15 publications

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“…As a result, significant 286 difference in the physical characteristics among different brands of a given drug 287 results in great variation in the efficacy of the drug which leads to either treatment brands comply for physical characteristics, packaging and labelling information requirements. Similar results have been reported for compliance in packaging and 291 labeling in different countries [7]…”

supporting

confidence: 80%

Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

Olbemo

Abuye

Leficho

et al. 2019

Preprint

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22 The safety of medicines is an essential part of patient safety. Global drug safety 23 depends on strong national systems that monitor the development and quality of 24 medicines. Poor quality medicines do not meet official standards for strength, quality, 25 purity, packaging and labelling. Hence, this study determines in-vitro quality 26 attributes of glibenclamide 5mg tablet marketed in Addis Ababa according to 27 drug monograph specifications. All tested brands meet the requirements for physical 28 inspection & complied specification for friability and hardness. Besides, the tested 29 brands met USP 38 specification for assay (99.96% to 108.85%) and for content 30 uniformity (AV values ranges from 3.35 to 10.04). In-vitro release tests were carried 31 out in phosphate buffer of 7.5 and 8.5 pH and showed drug release of ≥ 75%, met 32 USP 38 requirements. However, significant difference with respect to dissolution 33 profile among tested brands GL4 and GL6 were confirmed with comparator product 34 through model independent approach. Moreover, DE values were studied and 35 confirmed that GL4 and GL6 were not therapeutically interchangeable with innovator 36 product. 37 3 38 Introduction 39 Glibenclamide, which is also Glyburide in USA, is a second-generation sulfonylurea 40 oral hypoglycemic agent used in the treatment of noninsulin-dependent diabetes. It is 41 a Biopharmaceutical classification system (BCS) class II drug that has high 42 permeability and poor water solubility (Figure 1).[1] It is one of the most prescribed 43 long-acting anti-hyperglycemic agents that lower the blood glucose acutely by 44 stimulating the release of insulin from the pancreas, an effect dependent upon 45 functioning beta cells in the pancreatic islets. [2] 46 47 Figure 1. Chemical structure of Glibenclamide 48 49The food and Drug Administration (FDA) has dictated that in order for the generic 50 drugs to be approved, they have to pass many guided tests and examination for their 51 physicochemical characteristics, contain the same active constituents and strength, in 52 addition, to be bioequivalent to their innovator product. [3] 53 54 The quality concern of drugs is as old as drugs themselves. Despite all the advances 55 made over the years, this concern has not disappeared. In the recent past, the 56 unregulated proliferation of pharmaceutical industries and products has brought with 57 it many diverse problems of varying magnitude. [4] The use of ineffective, poor 58 quality, harmful medicines can result in therapeutic failure, exacerbation of disease, 59 resistance to medicines and sometimes death. It also undermines confidence in health 60 systems, health professionals, pharmaceutical manufacturers and distributors. Money 61 spent on ineffective, poor quality medicines is wasted -whether by consumers or 62 governments. [5] 63 64 The safety, efficacy, and quality of the medicines should be ascertained to provide a 65 desired pharmacological effect. Substandard drugs have been defined as those which 66 do not meet qualit...

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supporting

confidence: 80%

Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

Olbemo

Abuye

Leficho

et al. 2019

Preprint

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“…In Guatemala, Mansilla compared the dissolution profiles of generic glibenclamide in a dissolution medium at pH 7.5 and reported three formulations with an f2 greater than 50, but four others were not bioequivalent in vitro (39). In another investigation carried out by El-Sabawi et al in Jordan, five generic glibenclamide tablets were studied in a dissolution medium at pH 6.8 and reported f2 values below 50 (they did not publish dissolution percentages) (40).…”

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confidence: 99%

In Vitro Biopharmaceutical Equivalence of 5-mg Glibenclamide Tabletsin Simulated Intestinal Fluid Without Enzymes

Alvarado¹,

Muñoz²,

Bendezú³

et al. 2021

Dissolution Technol.

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This research evaluated the biopharmaceutical equivalence in vitro of three brands of glibenclamide 5-mg tablets (reference, brand name, and generic drugs) from Lima, Peru following the guidelines of the Biopharmaceutical Classification System (BCS). Glibenclamide is a BCS class 2 drug. Quality control parameters were evaluated including hardness, weight, friability, and drug content (hardness: 2.6-2.8 kg-f; weight [mean ± SD]: 103.3-109.8 mg ± 0.27-0.53; friability: 0.19-0.55%; content: 100.65-103.3%). To assess dissolution, apparatus 2 was used at 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) at pH 6.8; simulated intestinal fluid without enzymes was used as the dissolution medium.

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“…Tujuan dari uji waktu hancur adalah untuk memastikan bahwa tablet akan larut dalam cairan tubuh dan dapat diakses dalam keadaan molekulernya 26 . Disintegran adalah zat yang menyebabkan tablet pecah dan larut dalam air atau getah lambung, sehingga dapat mempengaruhi seberapa cepat suatu tablet hancur 23 .…”

Section: Evaluasi Mutu Fisik Odt Paracetamolunclassified

Pengaruh Variasi Konsentrasi Chitosan Sebagai Bahan Penghancur Terhadap Sifat Fisik Sediaan Orally Disintegrating Tablet (ODT) Paracetamol

Sulistriyani,

Nawangsari,

Kurniasih

2022

jsm

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An antipyretic analgesic drug called paracetamol is used in children to treat mild to moderate pain and fever. Orally Disintegrating Tablet (ODT), a medicine that dissolves in seconds, was created to help children who have difficulty swallowing tablets. The purpose of this study was to determine the effect of changes in the concentration of chitosan as a disintegrant in the formulation of ODT paracetamol. These ODT tablets are made using a wet granulation process. Paracetamol ODT tablets were produced in three formulations with 3.5% chitosan concentration; 7% and 14%. The findings showed that the optimal concentration of chitosan was 3.5%, which had an impact on the physical characteristics and dissolution of tablets. The results showed that paracetamol F1 ODT preparation with 3.5% chitosan concentration was the best formula. This was caused by chitosan with an average weight uniformity test value of 202.65±2.00 mg; uniformity of diameter and thickness 0.831±0.008 cm and 0.343±0.008 cm, hardness 5.4±0.34 kg; brittleness 0.23±0.02; disintegration time 24 seconds; da dissolution 99.56%. The findings for hardness (p= 0.011), friability (p= 0.046), and disintegration time (p= 0.000) all showed significant variation (p 0.05). It was concluded that the disintegration time of the tablets increased with the increase in the chitosan content. It is recommended that further research be conducted for analgesic and antipyretic tests to determine whether the tablets have an effective analgesic and antipyretic effect.

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Pharmaceutical evaluation of glibenclamide products available in the Jordanian market

Cited by 5 publications

References 15 publications

Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

Comparative In-Vitro Physicochemical Evaluation and Dissolution Profiling of Glibenclamide 5mg tablet Marketed in Addis Ababa, Ethiopia

In Vitro Biopharmaceutical Equivalence of 5-mg Glibenclamide Tabletsin Simulated Intestinal Fluid Without Enzymes

Pengaruh Variasi Konsentrasi Chitosan Sebagai Bahan Penghancur Terhadap Sifat Fisik Sediaan Orally Disintegrating Tablet (ODT) Paracetamol

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