ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1
Wan Po AL, 2001. Too much, too little, or none at all: dealing with substandard and fake drugs. Lancet 357 :1904.
-
2
Bott RF, Oliveira WP, 2007. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev Ind Pharm 33 :393–401.
-
3
Kommanaboyina B, Rhodes CT, 1999. Trends in stability testing, with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 25 :857–868.
-
4
Ballereau F, Prazuck T, Schrive I, Lafleuriel MT, Rozec D, Fisch A, Lafaix C, 1997. Stability of essential drugs in the field: results of a study conducted over a two-year period in Burkina Faso. Am J Trop Med Hyg 57 :31–36.
-
5
Videau JY, Fundafunda B, 2000. Generic drugs: the hidden issues of quality and cost. WHO Drug Inform 14 :77–81.
-
6
Behrens RH, Awad AI, Taylor RB, 2002. Substandard and counterfeit drugs in developing countries. Trop Doct 32 :1–2.
-
7
Hogerzeil HV, de Goeje MJ, bu-Reid IO, 1991. Stability of essential drugs in Sudan. Lancet 338 :754–755.
-
8
Roy J, 1994. The menace of substandard drugs. World Health Forum 15 :406–407.
-
9
Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA, 2001. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 357 :1933–1936.
-
10
Kayumba PC, Risha PG, Shewiyo D, Msami A, Masuki G, Ameye D, Vergote G, Ntawukuliryayo JD, Remon JP, Vervaet C, 2004. The quality of essential antimicrobial and antimalarial drugs marketed in Rwanda and Tanzania: influence of tropical storage conditions on in vitro dissolution. J Clin Pharm Ther 29 :331–338.
-
11
Petralanda I, 1995. Quality of antimalarial drugs and resistance to Plasmodium vivax in Amazonian region. Lancet 345 :1433.
-
12
Reidenberg MM, Conner BA, 2001. Counterfeit and substandard drugs. Clin Pharmacol Ther 69 :189–193.
-
13
Risha PG, Shewiyo D, Msami A, Masuki G, Vergote G, Vervaet C, Remon JP, 2002. In vitro evaluation of the quality of essential drugs on the Tanzanian market. Trop Med Int Health 7 :701–707.
-
14
Unwin N, 2001. Non-communicable disease and priorities for health policy in sub-Saharan Africa. Health Policy Plan 16 :351–352.
-
15
Opie LH, Seedat YK, 2005. Hypertension in sub-Saharan African populations. Circulation 112 :3562–3568.
-
16
Murray CJ, Lopez AD, 1997. Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study. Lancet 349 :1498–1504.
-
17
van der Sande MA, 2003. Cardiovascular disease in sub-Saharan Africa: a disaster waiting to happen. Neth J Med 61 :32–36.
-
18
Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J, 2005. Global burden of hypertension: analysis of worldwide data. Lancet 365 :217–223.
-
19
Caudron JM, Ford N, Henkens M, Mace C, Kiddle-Monroe R, Pinel J, 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13 :1062–1072.
-
20
Risha PG, Vervaet C, Vergote G, Van Bortel L, Remon JP, 2003. Drug formulations intended for the global market should be tested for stability under tropical climatic conditions. Eur J Clin Pharmacol 59 :135–141.
-
21
World Health Organization, 2006. Access to medicines: production and export of generic medicines under the TRIPS Agreement. WHO Drug Information 20 :22–25.
-
22
Amidon GL, Lennernas H, Shah VP, Crison JR, 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12 :413–420.
-
23
Uppoor VR, 2001. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Release 72 :127–132.
-
24
International Conference on Harmonization (ICH). ICH Q1A(R2): Stability testing of new drug substances and products [Current step 4 version; dated 6 February 2003]. ICH Harmonised Tripartite Guideline. Available at: http://www.ich.org/LOB/media/MEDIA419.pdf. Accessed December 2008.
-
25
Matthews BR, 1999. Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm 25 :831–856.
-
26
Unites States Pharmacopeial Convention, 2006. National Formulary (USP 29-NF 24). Rockville, MD: United States Pharmacopeia.
-
27
Moore JW, Flanner HH, 1996. Mathematical comparison of dissolution profiles. Pharm Technol 20 :64–74.
-
28
Shah VP, Tsong Y, Sathe P, Liu JP, 1998. In vitro dissolution profile comparison: Statistics and analysis of the similarity factor, f2. Pharm Res 15 :889–896.
-
29
Food and Drug Administration (FDA) and Centre for Drug Evaluation and Research, 1997. FDA Guidance for Industry: Dissolution Testing for Immediate Release Solid Oral Dosage Form. Rockville, MD: US Department of Health and Human Services.
-
30
Kibwage IO, Ogeto JO, Maitai CK, Rutere G, Thuranira J, Ochieng’ A, 1992. Drug quality control work in Daru: observations during 1983–1986. East Afr Med J 69 :577–580.
-
31
Raufu A, 2002. Influx of fake drugs to Nigeria worries health experts. BMJ 324 :698.
-
32
Raufu A, 2003. India agrees to help Nigeria tackle the import of fake drugs. BMJ 326 :1234.
-
33
Zahn M, Kallberg PW, Slappendel GM, Smeenge HM, 2006. A risk-based approach to establish stability testing conditions for tropical countries. J Pharm Sci 95 :946–965.
-
34
Newton PN, Green MD, Fernandez FM, Day NP, White NJ, 2006. Counterfeit anti-infective drugs. Lancet Infect Dis 6 :602–613.
-
35
Risha P, Msuya Z, Ndomondo-Sigonda M, Layloff T, 2006. Proficiency testing as a tool to assess the performance of visual TLC quantitation estimates. J AOAC Int 89 :1300–1304.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 441 | 361 | 56 |
| Full Text Views | 520 | 5 | 0 |
| PDF Downloads | 218 | 6 | 0 |
Influence of Tropical Climate Conditions on the Quality of Antihypertensive Drugs from Rwandan Pharmacies
Marc Twagirumukiza
Marc Twagirumukiza
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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An Cosijns
An Cosijns
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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Eveline Pringels
Eveline Pringels
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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Jean Paul Remon
Jean Paul Remon
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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Chris Vervaet
Chris Vervaet
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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Luc Van Bortel
Luc Van Bortel
Department of Internal Medicine, University Hospital, Kigali, Rwanda; Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium; Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
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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.
Author Notes
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
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-
1
Wan Po AL, 2001. Too much, too little, or none at all: dealing with substandard and fake drugs. Lancet 357 :1904.
-
2
Bott RF, Oliveira WP, 2007. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev Ind Pharm 33 :393–401.
-
3
Kommanaboyina B, Rhodes CT, 1999. Trends in stability testing, with emphasis on stability during distribution and storage. Drug Dev Ind Pharm 25 :857–868.
-
4
Ballereau F, Prazuck T, Schrive I, Lafleuriel MT, Rozec D, Fisch A, Lafaix C, 1997. Stability of essential drugs in the field: results of a study conducted over a two-year period in Burkina Faso. Am J Trop Med Hyg 57 :31–36.
-
5
Videau JY, Fundafunda B, 2000. Generic drugs: the hidden issues of quality and cost. WHO Drug Inform 14 :77–81.
-
6
Behrens RH, Awad AI, Taylor RB, 2002. Substandard and counterfeit drugs in developing countries. Trop Doct 32 :1–2.
-
7
Hogerzeil HV, de Goeje MJ, bu-Reid IO, 1991. Stability of essential drugs in Sudan. Lancet 338 :754–755.
-
8
Roy J, 1994. The menace of substandard drugs. World Health Forum 15 :406–407.
-
9
Taylor RB, Shakoor O, Behrens RH, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA, 2001. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 357 :1933–1936.
-
10
Kayumba PC, Risha PG, Shewiyo D, Msami A, Masuki G, Ameye D, Vergote G, Ntawukuliryayo JD, Remon JP, Vervaet C, 2004. The quality of essential antimicrobial and antimalarial drugs marketed in Rwanda and Tanzania: influence of tropical storage conditions on in vitro dissolution. J Clin Pharm Ther 29 :331–338.
-
11
Petralanda I, 1995. Quality of antimalarial drugs and resistance to Plasmodium vivax in Amazonian region. Lancet 345 :1433.
-
12
Reidenberg MM, Conner BA, 2001. Counterfeit and substandard drugs. Clin Pharmacol Ther 69 :189–193.
-
13
Risha PG, Shewiyo D, Msami A, Masuki G, Vergote G, Vervaet C, Remon JP, 2002. In vitro evaluation of the quality of essential drugs on the Tanzanian market. Trop Med Int Health 7 :701–707.
-
14
Unwin N, 2001. Non-communicable disease and priorities for health policy in sub-Saharan Africa. Health Policy Plan 16 :351–352.
-
15
Opie LH, Seedat YK, 2005. Hypertension in sub-Saharan African populations. Circulation 112 :3562–3568.
-
16
Murray CJ, Lopez AD, 1997. Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study. Lancet 349 :1498–1504.
-
17
van der Sande MA, 2003. Cardiovascular disease in sub-Saharan Africa: a disaster waiting to happen. Neth J Med 61 :32–36.
-
18
Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J, 2005. Global burden of hypertension: analysis of worldwide data. Lancet 365 :217–223.
-
19
Caudron JM, Ford N, Henkens M, Mace C, Kiddle-Monroe R, Pinel J, 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13 :1062–1072.
-
20
Risha PG, Vervaet C, Vergote G, Van Bortel L, Remon JP, 2003. Drug formulations intended for the global market should be tested for stability under tropical climatic conditions. Eur J Clin Pharmacol 59 :135–141.
-
21
World Health Organization, 2006. Access to medicines: production and export of generic medicines under the TRIPS Agreement. WHO Drug Information 20 :22–25.
-
22
Amidon GL, Lennernas H, Shah VP, Crison JR, 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 12 :413–420.
-
23
Uppoor VR, 2001. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Release 72 :127–132.
-
24
International Conference on Harmonization (ICH). ICH Q1A(R2): Stability testing of new drug substances and products [Current step 4 version; dated 6 February 2003]. ICH Harmonised Tripartite Guideline. Available at: http://www.ich.org/LOB/media/MEDIA419.pdf. Accessed December 2008.
-
25
Matthews BR, 1999. Regulatory aspects of stability testing in Europe. Drug Dev Ind Pharm 25 :831–856.
-
26
Unites States Pharmacopeial Convention, 2006. National Formulary (USP 29-NF 24). Rockville, MD: United States Pharmacopeia.
-
27
Moore JW, Flanner HH, 1996. Mathematical comparison of dissolution profiles. Pharm Technol 20 :64–74.
-
28
Shah VP, Tsong Y, Sathe P, Liu JP, 1998. In vitro dissolution profile comparison: Statistics and analysis of the similarity factor, f2. Pharm Res 15 :889–896.
-
29
Food and Drug Administration (FDA) and Centre for Drug Evaluation and Research, 1997. FDA Guidance for Industry: Dissolution Testing for Immediate Release Solid Oral Dosage Form. Rockville, MD: US Department of Health and Human Services.
-
30
Kibwage IO, Ogeto JO, Maitai CK, Rutere G, Thuranira J, Ochieng’ A, 1992. Drug quality control work in Daru: observations during 1983–1986. East Afr Med J 69 :577–580.
-
31
Raufu A, 2002. Influx of fake drugs to Nigeria worries health experts. BMJ 324 :698.
-
32
Raufu A, 2003. India agrees to help Nigeria tackle the import of fake drugs. BMJ 326 :1234.
-
33
Zahn M, Kallberg PW, Slappendel GM, Smeenge HM, 2006. A risk-based approach to establish stability testing conditions for tropical countries. J Pharm Sci 95 :946–965.
-
34
Newton PN, Green MD, Fernandez FM, Day NP, White NJ, 2006. Counterfeit anti-infective drugs. Lancet Infect Dis 6 :602–613.
-
35
Risha P, Msuya Z, Ndomondo-Sigonda M, Layloff T, 2006. Proficiency testing as a tool to assess the performance of visual TLC quantitation estimates. J AOAC Int 89 :1300–1304.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 441 | 361 | 56 |
| Full Text Views | 520 | 5 | 0 |
| PDF Downloads | 218 | 6 | 0 |