scholarly journals Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

Antibiotics ◽  
2021 ◽  
Vol 10 (9) ◽  
pp. 1096
Author(s):  
Ping Yang ◽  
Shigeru Fujimura ◽  
Yawei Du ◽  
Bei Zhang ◽  
Li Yang ◽  
...  

This study aimed to provide comparative information of pharmaceutical properties, including particle morphology and distribution uniformity, solubility, presence of residual solvent and insoluble particles, and antimicrobial activities, between brand-name meropenem (Mepem®, BNM) and its six generic products (GPs A-F) marketed in China. Particles of GP-A and -C in dry powder had similar diameters of BNM, while other GPs were larger. Only BNM and GP-A were completely dissolved within 100 s in the lab condition. No insoluble particles >25 μm in diameter were detected in BNM and GP-E. Regarding stability of GPs solutions evaluated by concentration of open-ring metabolites at 6 h and 8 h, BNM showed the lowest open-ringed metabolite concentrates. Residual solvent of acetone detected in one GP showed the maximum value, while ethanol and ethyl acetate were detected both in product E and product F. The concordance rates (%) of minimum inhibitory concentration (MIC) of each generic compared to BNM were 89.5, 85, 87.5, 88, 88.5, and 86.5, respectively, although no significant difference was reached in MIC. Pharmaceutical characteristic differences between the BNM and GPs identified in this study could provide insights into understanding the deviations in the drug manufacturing processes of generic drugs.

2020 ◽  
Vol 16 ◽  
Author(s):  
Su-hua Zhang ◽  
Shan-shan Wei ◽  
Zhen-yu Zhu ◽  
Ying Chen ◽  
Hua-lin Cai ◽  
...  

Background: Up to date, generic linezolid injections produced by Chinese manufacturers were not widely used in clinic in China. Quality evaluation of linezolid injections produced in China is prerequisite, which has rarely been performed. Objective: This study aimed to evaluate the quality of branded and generic injections from different manufacturers and to provide a basis for the quality control. Methods: In this study, the content of linezolid, related impurities and enantiomer of linezolid were determined by high performance liquid chromatography. The content of glucose was determined by iodine method. The insoluble particles and visible and sub-visible particles were determined by light blockage and lamp test respectively. Osmotic pressure was determined by freezing point depression method. Standard solution control method was used to check the color of the injection. Linezolid injections from different manufacturers were evaluated uniformly. Results: No significant difference was found in the content of linezolid, glucose, related impurities, visible particles, insoluble particles, pH value, and solution color between branded and generic drugs from different manufacturers in China. Conclusion: The quality of samples from different manufacturers is consistent. Although the physicochemical similarity does not guarantee the bioequivalence of studied branded and generic linezolid injections, the results provide references for further bioequivalence study. Generic injections offer more affordable treatment options for patients with infections than expensive branded drugs.


2016 ◽  
Vol 25 (4) ◽  
pp. 417-429
Author(s):  
Kaoru Ito ◽  
Shunya Ikeda ◽  
Masaki Muto

1970 ◽  
Vol 12 (4) ◽  
pp. 192-196
Author(s):  
Devindra Sood ◽  
Alka Pandey ◽  
Rajeev Sood ◽  
Nagesh Gupta ◽  
Ravinder Kumar Bajaj ◽  
...  

Aim: To study the medication costs of various topical glaucoma medications using data collected from real world use by patients.Methods: Patients with primary open angle glaucoma treated at glaucoma clinics in 5 hospitals (1 rural and 4 urban) in northern India from 1 January to 30 June 2008 were enrolled. The number of days each bottle of medication lasted was recorded, and the mean cost per day was computed from the maximum retail price and mean number of days each medication lasted.Results: 790 of 801 eligible patients completed the study. The mean number of days that a bottle of medication lasted was found to be highest for Xalatan® and Xalacom® at 35.23 days and 35.00 days, respectively. The brand name prostaglandin analogues all lasted for a mean of more than 30 days: Xalatan, 35.23 days (SD, 4.14 days); Lumigan®, 31.37 days (SD, 5.31 days); and Travatan®, 34.84 days (SD, 6.51 days), while the generic eye drops lasted for about 21 days: latanoprost, 20.69 days (SD, 3.69 days) and bimatoprost, 21.39 days (SD, 4.34 days). The cost of the generic medication was less than the brand name medication in all groups (for example, bimatoprost, Indian rupees 9.76 versus Indian rupees 12.33) except for brimonidine/timolol (Indian rupees 8.73 versus Indian rupees 8.66). Further analysis in 2009 showed that, for latanoprost, brimonidine and brimonidine/timolol, the difference between the brand name and generic medications decreased in 2009 over 2008 (in the latanoprost group, the cost difference over the year reduced from Indian rupees 592 in 2008 to Indian rupees 523 in 2009); the cost difference for bimatoprost increased from 2008 to 2009.Conclusion: When both cost and number of days a bottle lasts were considered over the long term, use of generic medications might not minimise the cost of glaucoma medical management by much when compared with the brand name medication.


Author(s):  
Rakhi Rashmi

India has changed its patent policy in 2005. It was compliance to WTO TRIPs provision and after this there was prohibition on process or generic manufacturing. India is the biggest supplier of affordable generic medicines and this patent protection is said to be beneficial to novel drug manufacturing countries. The generic drugs can be a differentiation factor between lives starting point and the ending point for millions of people in developing countries. This remains an obstacle to inexpensive generic medicines which results in devastating impact on the poorer people. These patent laws allow large MNC's to place ‘profits over people'. World Health Organisation report price of medicines are important for maintaining the affordability and access of the medicines. This research evaluates the strategies and practices of Glaxo Smith Kline in contribution towards the access to medicines and their contribution of corporate social responsibility in India.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Yuki Ito ◽  
Konan Hara ◽  
Byung-Kwang Yoo ◽  
Jun Tomio ◽  
Yasuki Kobayashi

Abstract Background Higher income population tend to prefer brand-name to generic drugs, which may cause disparity in access to brand-name drugs among income groups. A potential policy that can resolve such disparity is imposing a greater co-payment rate on high-income enrollees. However, the effects of such policy are unknown. We examined how patients’ choice between brand-name and generic drugs are affected by the unique income-based co-payment rates in Japan; 10% for general enrollees and 30% for those with high income among the elderly aged 75 and over. Methods We drew on cross-sectional price variation among commonly prescribed 311 drugs using health insurance claims data from a large prefecture in Japan between October 2013 and September 2014 to identify between-income-group differences in responses to differentiated payments. Results Running 311 multivariate logistic regression models controlling individual demographics, the median estimate indicated that high-income group was 3% (odds ratio = 0.97) less likely to choose a generic drug than the general-income group and the interquartile estimates ranged 0.92–1.02. The multivariate feasible generalized least squares model indicated high-income group’s higher likelihood to choose brand-name drugs than the general-income group without co-payment rate differentiation (p < 0.001). Such gap in the likelihood was attenuated by 0.4% (p = 0.027) with an US$1 increase in the difference in additional payment/month for brand-name drugs between income groups — no gap with US$10 additional payment/month. This attenuation was observed in drugs for chronic diseases only, not for acute diseases. Conclusions Income-based co-payment rates appeared to reduce disparity in access to brand-name drugs across income groups, in addition to reducing total medical expenditure among high-income group who shifted from brand-name drugs to generic ones due to larger drug price differences.


Author(s):  
Mohd Redhuan Dzulkipli ◽  
Siti Noorsuriani Maon ◽  
Mohamed Azmi Hassali

The objective of this study was to evaluate the population behavioural influence towards generic medicines use in a Klang Valley. A self-administered questionnaire in the Klang Valley, Malaysia, was distributed conveniently. A total of 222 respondents have participated in the study (response rate 57.8%). The majority of the respondents (87.7%) have reported considerable amount of knowledge on the generic medicine availability in the market. In comparison of sociodemographic influence, only household size was found to influence the respondent’s knowledge and curiosity. For the perception, there was a statistically significant difference in attitude scores for respondents who had good level of knowledge (M = 3.322, SD = 0.516) and poor level of knowledge (M = 3.011, SD = 0.591) towards generic medicines; t(220) = –4.180, p < 0.05. In terms of subjective norms, data findings indicate a statistically significant difference in scores for respondents who had good level of knowledge (M = 3.456, SD = 0.704) and poor level of knowledge (M = 3.057, SD = 0.616) towards generic medicines; t(220) = –4.393, p < 0.05. Similarly, this study found a statistically significant difference in perceived behavioural control scores for respondents who had good level of knowledge (M = 3.605, SD = 0.548) and poor level of knowledge (M = 3.121, SD = 0.577) towards generic medicines; t(220) = –6.350, p < 0.05. Therefore, these results reveal that good level of knowledge really influence the level of perceptions among consumers of generic medicines. It is imperative that more initiatives to be introduced by the government to promote the practice to prescribe generic drugs to the population. The need to educate both health professionals and patients on the availability of the cheaper and bioequivalence medicine should be put into formality, thus increasing the awareness of the patient of the generic medicine and next reduce the dependency of the costlier innovator brand medicine in the prescription at both public and private healthcare settings.


Medicina ◽  
2011 ◽  
Vol 47 (11) ◽  
pp. 89
Author(s):  
Yutaka Inoue ◽  
Miruto Matsumoto ◽  
Masayuki Kimura ◽  
Toru Tanaka ◽  
Ikuo Kanamoto

Background and Objective. In external preparations, types and ratios of additives are not necessarily the same for brand-name drugs and generic drugs. Thus, the physicochemical properties of preparations may differ despite the fact that they contain the same ingredients or additives. This study examined differences in brand-name and generic versions of nadifloxacin (NFX) creams. Material and Methods. Three types of NFX creams (NFX-A, NFX-B, and NFX-C) were used. The viscosity of each preparation was determined, its yield value was calculated, and each preparation was subjected to light microscopy, x-ray powder diffraction, and near-infrared absorption spectroscopy. Results. Comparison of viscosity of different preparations revealed that NFX-B had a lower viscosity than NFX-A and NFX-C (14.5 vs. 24.6 and 17.9 Pa·s). NFX-B also had a lower yield value than NFX-A and NFX-C. Microscopy revealed that NFX-A and NFX-B had satisfactory emulsification although crystallization was observed with NFX-C. Near-infrared absorption spectroscopy revealed changes in the absorption spectra of NFX-B in comparison with those of NFX-A and NFX-C that were due to differences in water content and differences in fat and oil content. Conclusions. These findings confirmed that there were differences in the viscosity and flattening of NFX-A, NFX-B, and NFX-C. In addition, microscopy revealed differences in emulsification and it revealed the precipitation of NFX crystals in NFX-C. Near-infrared absorption spectroscopy revealed that differences in the type and amount of additives and water content in the creams had contributed to differences in the preparations.


2016 ◽  
Vol 511 (2) ◽  
pp. 1136-1137
Author(s):  
Sebastiano A.G. Lava ◽  
Maristella Santi ◽  
Mario G. Bianchetti
Keyword(s):  

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