Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

Arnet, Isabelle; Altermatt, Matthias; Roggo, Yves; Schnetzler, Gabriel

doi:10.1179/1973947814y.0000000208

Cited by 15 publications

(7 citation statements)

References 21 publications

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“…Contaminating amounts of the thiotriazinone impurity in a 1 g ceftriaxone vial were determined by HPLC as 1.35 0.07 mg, 2.92 0.19 mg, and 1.15 0.13 mg n 3 for the original, generic A , and generic B ceftriaxone products, respectively, giving an impurity scale of generic B original generic A. The contaminating amount of thiotriazinone in the original ceftriaxone product i.e., 0.135 w/w of ceftriaxone in a 1 g vial is comparable to a previous report 7 . …”

Section: Resultssupporting

confidence: 82%

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products

Shinako

Sugiyama

Saito

et al. 2016

Showa Univ J Med Sci

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: This study examined the effect of thiotriazinone impurity on the generation of insoluble microparticles IMPs associated with ceftriaxone-calcium salt precipitation in original Rocephin and Japanese generic ceftriaxone A ; Sawai, B ; Nichi-Iko products when mixed with Ca 2 4.3 mEq/l. We found that the generation rate of IMPs associated with ceftriaxone-calcium salt precipitation among the three ceftriaxone products tested was in the order of generic A original generic B , as assessed by light obscuration particle counting. Typically, after 60 min, one of the generic ceftriaxone B -calcium mixtures was highly opaque with numerous aggregates of milky-white precipitates, the original ceftriaxone-calcium mixture exhibited noticeable IMPs, and the second generic ceftriaxone A -calcium mixture was transparent. The levels of thiotriazinone contaminants, known to be a major impurity in ceftriaxone products, were determined by HPLC and found to be in the order of generic A original generic B. Moreover, the addition of a small amount of thiotriazinone into the generic ceftriaxone B -calcium mixture significantly decreased the amount of IMPs, suggesting that the impurity retards ceftriaxone-calcium crystal growth. We thus concluded that the thiotriazinone impurity acts as a suppressive factor of ceftriaxone-calcium salt precipitation, and that the high level of thiotriazinone impurity in the ceftriaxone B product could underlie its lowest rate of IMP generation when mixed with calcium. We thus recommend caution regarding the clinical risk of ceftriaxone-calcium compatibility due to impurity contamination in ceftriaxone products.

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Section: Resultssupporting

confidence: 82%

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products

Shinako

Sugiyama

Saito

et al. 2016

Showa Univ J Med Sci

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“…INN prescribing can help to address this coupled with only the INN name appearing on the packages of multiple sourced medicines. Having said this, there are concerns with the quality of generics in many LMICs, which challenges routine INN prescribing [201][202][203][204]. The launch of the Lomé initiative in Africa in January 2020 to address substandard as well as falsified medicines is a key step forward to enhance physician and patient trust in generic medicines across countries building on earlier WHO initiatives [205][206][207].…”

Section: Health Authority and Other Initiatives To Enhance The Prescr...mentioning

confidence: 99%

Evidence-based public policy making for medicines across countries: findings and implications for the future

et al. 2021

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Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

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“…On the other hand, the two cases of toxicity were related to CNS symptoms, although patients had previously tolerated the use of the ABC + LMV + DTG co-formulated tablet. It could be that both clinicians and patients were especially vigilant in the identification and interpretation of new symptoms after the change of formulations, but it could also be the case that generic pharmaceutical specialties include different percentages of impurities, as has already been possible evidenced in other fields of Medicine [ 15 – 17 ]. Nowadays, the most efficient antiretroviral treatment for HIV infection in Spain is, precisely, the ABC + 3TC + DTG (Triumeq®) tablet [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of the switch of Triumeq® to generic (abacavir + lamivudine) + Tivicay®: data at 24 weeks

Olalla

Pérez-Stachowski

Tortajada

et al. 2018

BMC Pharmacol Toxicol

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BackgroundGeneric drugs may help to support antiretroviral treatment. We want to assess the efficacy and safety at 24 weeks of the change of coformulated (abacavir + lamivudine + dolutegravir) to (abacavir + lamivudine) coformulated as a generic pharmaceutical specialty + dolutegravir.MethodsBetween February and June 2017, switch from Triumeq® to a generic pharmaceutical specialty co-formulated tablet (abacavir + lamivudine) plus Tivicay® was made. Demographic, viroimmunological characteristics and the Charlson index were collected. Six months after switching, efficacy and safety were evaluated.ResultsSwitch was made in 93 patients, with a mean age of 47 years, after six months there were five patients (5.4%) with viral loads between 50 and 400 copies, no patient had viral loads of greater amount. There were 2 interruptions due to toxicity (2.15%), in relation to symptoms of the central nervous system. There were no differences in the amount of years with HAART, nor in the previous months with the STR regimen based on abacavir + lamivudine + dolutegravir, nor in the Charlson index. The effective saving in 2017 derived from the change in these 93 patients was € 125.512.ConclusionsThe change from a regimen of abacavir + lamivudine + dolutegravir seems to be safe and effective at 24 weeks.

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Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

Cited by 15 publications

References 21 publications

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products

Evidence-based public policy making for medicines across countries: findings and implications for the future

Efficacy and safety of the switch of Triumeq® to generic (abacavir + lamivudine) + Tivicay®: data at 24 weeks

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Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

Cited by 15 publications

References 21 publications

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>&reg;</sup>) and Japanese Generic Ceftriaxone Products

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>&reg;</sup>) and Japanese Generic Ceftriaxone Products

Evidence-based public policy making for medicines across countries: findings and implications for the future

Efficacy and safety of the switch of Triumeq® to generic (abacavir + lamivudine) + Tivicay®: data at 24 weeks

Contact Info

Product

Resources

About

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products

Effect of Thiotriazinone Impurity on Insoluble Microparticle Generation Associated with Ceftriaxone-calcium Salt Precipitation in Original (Rocephin<sup>®</sup>) and Japanese Generic Ceftriaxone Products