A Risk-Based Approach to Establish Stability Testing Conditions for Tropical Countries

Zahn, Manuel; Kållberg, Per; Slappendel, Gijsbert M.; Smeenge, Harold M.

doi:10.1002/jps.20584

Cited by 15 publications

(9 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This was a risk-based assessment where we identified pharmaceutical quality issues with a higher risk profile [17, 22]. Unlike comprehensive quality assessments that include dissolution and impurity testing, we focused specifically on the identity and content of the medicines circulating in the retail pharmaceutical market in Tanzania to inform regulators and public health stakeholders of areas that need attention.…”

Section: Resultsmentioning

confidence: 99%

The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania

et al. 2016

View full text Add to dashboard Cite

IntroductionThe purpose of this study was to investigate the quality of a select group of medicines sold in accredited drug dispensing outlets (ADDOs) and pharmacies in different regions of Tanzania as part of an in-depth cross-sectional assessment of community access to medicines and community use of medicines.MethodsWe collected 242 samples of amoxicillin trihydrate, artemether-lumefantrine (ALu), co-trimoxazole, ergometrine maleate, paracetamol, and quinine from selected ADDOs and pharmacies in Mbeya, Morogoro, Singida, and Tanga regions. The analysis included physical examination and testing with validated analytical techniques. Assays for eight of nine products were conducted using high-performance thin-layer chromatography (HPTLC). For ALu tablets, we used a two-tiered approach, where tier 1 was a semi-quantitative Global Pharma Health Fund-Minilab® method and tier 2 was high-performance liquid chromatography (HPLC) as described in The International Pharmacopoeia’s monograph for artemether-lumefantrine.Results and DiscussionThe physical examination of samples revealed no defects in the solid and oral liquid dosage forms, but unusual discoloration in an injectable solution, ergometrine maleate. For ALu, the results showed that of 38 samples, 31 (81.6%) passed tier 1 testing and 7 (18.4%) gave inconclusive drug content results. The inconclusive ALu samples were submitted for tier 2 testing and all met the quality standards. The pass rate using the HPTLC and TLC/HPLC assays was 93.8%; the failures were the ergometrine maleate samples purchased from both ADDOs and pharmacies. The disintegration testing of the solid dosage forms was conducted in accordance with US Pharmacopeia monographs. Only two samples of paracetamol, 1.2% of the solid dosage forms, failed to comply to standards. The study revealed a high overall rate of 92.6% of samples that met the quality standards. Although the overall failure rate was 7.4%, it is important to note that this was largely limited to one product and likely due to poor distribution and storage rather than poor manufacturing practices.ConclusionsOver 90% of the medicines sold in ADDOs and pharmacies met quality standards. Policy makers need to reconsider ergometrine maleate’s place on the list of medicines that ADDOs are allowed to dispense, by either substituting a more temperature-stable therapeutically equivalent product or requiring those sites to have refrigerators, which is not a feasible option for rural Tanzania.

show abstract

Section: Resultsmentioning

confidence: 99%

The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania

et al. 2016

View full text Add to dashboard Cite

show abstract

“…By using 14 C-OVA as a tracer, we measured that 248±29 ng influenza vaccine was delivered to each mouse. The storage temperature was following WHO guidelines [33]. Then, at months 0, 1, 2, 3 and 6, ten of the coated patches were used to immunize groups of five C57BL/6 mice.…”

Section: Vaccination Of Micementioning

confidence: 99%

“…First, as one test case, influenza vaccine dry-coated NPs are stable for at least 6 months at 23 ºC, so there is a potential to remove the huge burden of cold chain in vaccination campaign in temperate and subtropical regions [33]. Second, associated with targeted delivery of influenza vaccines to thousands of skin's APCs, the NP achieves unprecedented dose sparing (30 fold).…”

Section: Potential Utility Of Np In Low-resource Regionsmentioning

confidence: 99%

Improving the reach of vaccines to low-resource regions, with a needle-free vaccine delivery device and long-term thermostabilization

Chen

Fernando

Crichton

et al. 2011

Journal of Controlled Release

171

140

View full text Add to dashboard Cite

“…lation development. 2,4,7,33 This study shows that probably not all manufacturers comply with this requirement. This is in line with the idea that substandard drug cases are under-reported and are often confused with counterfeit drugs, causing limited understanding of the extent of the problem.…”

Section: Discussionmentioning

confidence: 87%

Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies

Twagirumukiza¹,

Cosijns²,

Pringels³

et al. 2009

The American Journal of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

Abstract. The objective of this study was to assess the quality of antihypertensive drugs and to investigate the influence of tropical storage conditions. Drug content and in vitro dissolution tests were performed on 10 test formulations (from Rwanda) and 6 reference formulations (from Belgium or France) after purchase and after 6-month storage under long-term (25 ± 2°C and 60 ± 5% relative humidity [RH]) and accelerated (40 ± 2°C and 75 ± 5% RH) testing conditions. Twenty percent of test formulations were of substandard content at the time of purchase. After 6 months at accelerated testing conditions, 7 of 10 test formulations were substandard in content and 8 were substandard for the combined criteria of drug content and dissolution, whereas no reference drug became substandard. This study shows that, apart from some drugs being already substandard from purchase, accelerated testing conditions (simulating tropical climate) have deleterious effects on the majority of antihypertensive drug formulations found in the Rwandan market.

show abstract

A Risk-Based Approach to Establish Stability Testing Conditions for Tropical Countries

Cited by 15 publications

References 3 publications

The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania

The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania

Improving the reach of vaccines to low-resource regions, with a needle-free vaccine delivery device and long-term thermostabilization

Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies

Contact Info

Product

Resources

About