Generic drug- review of ibuprofen
- VernacularTitle:Ерөнхий нэршлийн эм- ибупрофен эмийн тухай тойм
- Author:
Nomingerel B
1
;
Enkhzaya B
2
;
Ulambayr L
1
;
Baynmunkh A
3
Author Information
1. Mongolian University of Pharmaceutical Sciences
2. Monos Pharm
3. Drug Research Institute
- Publication Type:Journal Article
- From:
Mongolian Pharmacy and Pharmacology
2021;19(2):120-129
- CountryMongolia
- Language:Mongolian
-
Abstract:
In recent years, due to increased drug use global generic drugs in 2019, the industry generated 79 billion U.S. dollars in generic prescription drug revenue worldwide. Until 2026, the global prescribed generics market is expected to exceed 100 billion U.S. dollars.
The study of generic drugs will be based on the list of comparative products approved by the World Health Organization. The World Health Organization has approved the International List of Essential medicines of international comparator products based on the ANNEX-7 and ANNEX-8. That list includes a total of 572 international comparator products.
Generic drugs has an important role in the market of any country, and generic drugs are required to be similar to comparator products in terms of therapeutic activity, quality, and safety. In multi sources generic drug is equivalent to the treatment of the comparable product, allowing the product to be used as a substitute for analysis.
Some results of recent studies of Ibuprofen is mentioned above here.
In 2010 in Madrid, Spain, the study Investigation on the possibility of biowaivers for Ibuprofen was conducted by Covadonga Lvarez, Ignacio Nunenz, Juan J. Torrado and John Gordon. The aim of the study was to investigate the ability of in vitro dissolution to ensure bioequivalence of ibuprofen products. Ibuprofen is a Biopharmaceutics Classification System (BCS) class II drug with low solubility at pH 1.2 and 4.5 and high solubility at pH 6.8. In vivo studies were performed following the updated Declaration of Helsinki, with the approval of the Ethical Committee for Clinical Re- search of the Hospital and the Spanish Agency for Medicines and Health Care Products.
In-vitro evaluation of the pharmaceutical quality of some ibuprofen tablets dispensed in Nigeria, University of Benin, Department of Pharmaceutics and Pharmaceutical Technology, analyzed Florence E. Eichie*, Ikhuoria M. Arhewoh and Oliver C. Ezeobi. The Ibuprofen tablets were assessed according to British Pharmacopoeia (BP), and unofficial standards as recommended by the manufacturers. Of the 19 brands of tablets assessed, 12 brands passed the uniformity of content test while 15 brands passed the disintegration test and only four brands passed the dissolution test. Ibuprofen tablets dispensed in Nigeria varied considerably in their pharmaceutical quality.
In 2015 in Nigeria, Benin City, University of Benin, Department of Pharmaceutics and Pharmaceutical Technology, Studies of comparative UV−HPLC analysis of ten brands of ibuprofen tablets. Those studies investigated the pharmaceutical equivalence of ten brands of ibuprofen tablets (400 mg) purchased from pharmacies in Benin City, Nigeria. According to the results of the study, the weight of the total brand of drugs varies significantly, fluctuates between 6.14-15.93kp due to the action of pressure, and the melting point does not meet the requirements of brands B and G. Drug decomposition brands C, F, H, I meet the requirements, but the solubility indicators D, E, G, I, J inadequate requirements. Brands C and D inadequate requirements for determining the content of ibuprofen in ultraviolet light. However, all brands of drugs approved requirements for HPLC.
In 2020 in Mekelle, Ethiopia, Comparative In Vitro Quality Evaluation of Different Brands of Ibuprofen Tablets Marketed. Studies included seven brands of 400 mg lm coated ibuprofen tablets were randomly purchased from different pharmacies and drug stores in Mekelle. Weight uniformity, hardness, friability, disintegration, dissolution and assay of drug content were performed based on specications stipulated in the British Pharmacopeia (BP) and the United State Pharmacopeia (USP). All the evaluated products of ibuprofen tablets marketed in Mekelle were within the acceptable compendial limits based on the in vitro results of the study except product IBU-E which failed in the disintegration test.
The aim of the study to determine the in vitro quality of some domestic and imported ibuprofen drugs.
- Full text:MPPJ-2021-19(2)-120-129.pdf
