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PURPOSE: Few studies have been investigated the in vivo efficacy of generic vancomycin products available outside of the United States. In this study, we aimed to compare the in vivo pharmacokinetics (PK) and pharmacodynamics (PD) of five generic vancomycin products available in Korea with those of the innovator.MATERIALS AND METHODS: The in vitro vancomycin purity of each product was examined using high-pressure liquid chromatography. Single-dose PK analyses were performed using neutropenic mice. The in vivo efficacy of vancomycin products was compared with that of the innovator in dose-effect experiments (25 to 400 mg/kg per day) using a thigh-infection model with neutropenic mice.RESULTS: Generic products had a lower proportion of vancomycin B (range: 90.3–93.8%) and a higher proportion of impurities (range: 6.2–9.7%) than the innovator (94.5% and 5.5%, respectively). In an in vivo single-dose PK study, the maximum concentration (C(max)) values of each generic were lower than that of the innovator, and the geographic mean area under the curve ratios of four generics were significantly lower than that of the innovator (all p<0.1). In the thigh-infection model, the maximum efficacies of generic products reflected in maximal effect (E(max)) values were not significantly different from the innovator. However, the PD profile curves of some generic products differed significantly from that of the innovator in mice injected with a high level of Mu3 (all p≤0.05).CONCLUSION: Some generic vancomycin products available in Korea showed inferior PK and PD profiles, especially in hetero-vancomycin-resistant mice infected with Staphylococcus aureus.
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Objective To analyze the impact of “4+7” City Drug Centralized Procurement Program on the utilization of cardiovascular medicines, and to provide a reference for optimizing the policy of generic medicines as substitutes for original medicines. Methods Eleven drugs, both generic and original were selected for treatment of cardiovascular diseases in an outpatient clinic of a tertiary hospital in Shanghai. The proportion of use of generic drugs and original drug, ratio of used amount, daily cost ratio, and potential cost savings rate of replacement of original drug by generic drug were analyzed before the “4+7” (2018.04.01-2018.09.30) and after the “4+7” (2019.04.01-2019.09.30). Results After the “4+7”, the proportion of the original research drug used decreased from 84.32% to 58.12%, and the ratio of amount of used money decreased from 86.02% to 78.16%; the proportion of generic medicines used increased from 15.68% to 41.88%, and the ratio of amount used increased from 13.98% to 21.84%; the daily cost ratio of generic medicine to original medicine decreased from 0.87 to 0.39. Under the same condition, the potential cost savings of replacing the original drug with generic drugs before and after the “4+7” were RMB 3.703 million and RMB 3.399 million, respectively, and the cost saving rate was 35% and 61%, respectively. Conclusion The “4+7” City Drug Centralized Procurement Program significantly increase the use of cardiovascular generic drugs and significantly reduce the cost of drugs; however, it has a small impact on the quantity and amount of generic drugs used. There is still a significant potential for cost saving. It is recommended to further increase the publicity of the policy on the substitution of original drug by generic, expedite the consistency evaluation process of generic drugs and take measures to avoid the widening of the price gap between original drugs and generics.
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Background: Hypertension, a chronic condition requiring lifelong care, affects approximately 25.3% Indian population. Average annual hypertension management cost which also includes medication cost varies from Rs. 4042 to 7621, amounting up to 40% of total household income of few families. Selection of a different brand or generic formulation may have an immense impact on total expenditure for treatment of hypertension. Present study aims at determining cost variability and cost analysis of various single drug antihypertensive formulations available in Indian market.Methods: One most prescribed drug, each from Joint National Committee recommended antihypertensive- thiazide diuretics, calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin-receptor blockers and ? blockers were selected for cost analysis. Cheapest, costliest and median priced formulations were searched for individual drugs and were compared to the price of their generic counterparts.Results: Generic formulations of hydrochlorothiazide, amlodipine, enalapril, losartan and atenolol were cheaper even than their respective cheapest innovator formulations. Costliest innovator formulation of amlodipine was 1750% expensive than generic one. Costliest counterparts of generic formulations were many folds overpriced. Similarly, innovator formulation of losartan was up to 953.89% costly than generic one. Innovator formulations of hydrochlorothiazide were the least costly than its generic counterpart, yet being at least 150% more expensive. Also, there exists considerable broad range of price among similar innovator formulations.Conclusions: By prescribing generic antihypertensive drug, we can reduce treatment expenditure by many folds. Same feat can be marginally achieved by using lower cost innovator formulations.
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In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.
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Background: The emergent of many pharmaceutical companies producing their own generic type of drugs after the patent of innovator drugs expired can improve the general healthcare delivery systems as well as decreasing the healthcare costs. But it also raises a few issues with one of it is the widespread of substandard and counterfeit product. Postsurveillance study to assess product parameter of various generics drug marketed is crucial. This kind of monitoring reduces a country’s economical burden on health issues from diseases due to fraudulent and substandard drugs usage. Purpose: The main objective of this study is to perform a comparative evaluation of the physicochemical properties of five commercially available leading brands of Atenolol tablets marketed in Kuala Lumpur. Method: The quality control parameters of five different brands of atenolol tablets were atenolol tablet assessed included uniformity of content, uniformity of weight, friability, crushing strength, disintegration and dissolution tests as well as content uniformity of the tablets. All the tablets were assessed for conformity with British Pharmacopoeia (BP) standards. Results: All the five brands of the tablets passed the British Pharmacopoeia (BP) standards for weight uniformity, disintegration, friability, content uniformity and hardness tests. Conclusion: The quality control parameters of all five top selling brands of atenolol tablets marketed in Kuala Lumpur analyzed passed all the BP and USP quality specifications and were physically and chemically equivalent.
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Methotrexate is a Folic Acid Antagonist and used as an Antineoplastic agent. In this study Methotrexate immediate release tablet is developed, which was stable and bioequivalent generic tablet formulation equivalent to innovator’s product. The developed tablet formulation shows similar dissolution and disintegration profile as that of innovator tablet. The immediate release tablet was prepared by Wet Granulation method. The in vitro release was carried out in 0.1N Hydrochloric Acid. The in-vitro release at 50 rpm showed similar dissolution profile when compared with the innovator tablet. The stability studies were carried out and there was no significant change in the drug content, assay, and DT and dissolution rate.