Substandard & Counterfeit Medicines. Anita Nair AK. Prof. Jennifer Dressman In collaboration with Prof. Jackson Lauwo University of Papua New Guinea

Transcription

1 Substandard & Counterfeit Medicines Anita Nair AK. Prof. Jennifer Dressman In collaboration with Prof. Jackson Lauwo University of Papua New Guinea WPF WS/2010

2 What are Counterfeit Medicines? A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging. Reference: 2 WHO; Department of Essential Drugs and Other Medicines; Counterfeit Medicines - Guidelines for the development of measures to combat counterfeit drugs

3 Probability of Different Types of Counterfeiting Incorrect quantities of API(s) Correct amount(s) of API(s) Incorrect API(s) No API(s) 3 Reference: WHO; 2003 report;

4 Extent of Substandard/Counterfeit Medicines in Papua New Guinea 4

5 Detection and Evaluation of Counterfeit Medicines in Papua New Guinea Amoxicillin (Antibiotic) Amodiaquine (Antimalarial) Artemether (Antimalarial) 5

6 Evaluation Methodology Dosage Form Physical & Visual Inspection Identification & Quantitative Analysis Uniformity of Content Dissolution Testing 6

7 Uniformity of Content The uniformity of content was performed by extracting the API (Amoxicillin) in water by sonication for 15 min Analysis was carried out by HPLC USP limits: % of the labeled amount of the API and a standard deviation of ±6% (n=6) 7

8 Dissolution Methodologies USP Method Alternative Method Apparatus I (250mg) II (500mg) Medium water SIFsp, ph 6.8 Volume [ml] Temperature [ C] Agitation [rpm] 100 (Basket) 50 (Paddle) Analysis UV (272nm) UV (230nm) II 75 Q limit 80% dissolution of the labeled amount of the API in 60 min 80% dissolution of the labeled amount of the API in 60 min 8

9 Amoxicillin Amoxicillin is one of the top five drugs being sold in PNG 6 products have been investigated (in some cases two batches of the same product) Total number of samples: 9 Randomly collected in Port Moresby, Papua New Guinea by Dr. Lauwo 9

10 10 Q1A/Q1B: Amoxicillin Capsules 500mg, NCPC

11 Q1A/Q1B: Organoleptic Properties Presence of drug in the samples were confirmed by TLC Hard gelatine capsule Description: red cap and yellow body with #500 and AMOXI imprinted; free flowing white powder Capsules shells were not tightly locked 11

12 Q1A/Q1B: Uniformity of Content Q1A Q1B % API Mean SD % API Mean SD Capsule Capsule Capsule Capsule Capsule Capsule Q1A: Passes; Q1B: Need to test more capsules 12

13 % Drug dissolved % Drug dissolved Q1A/Q1B: Dissolution Q1A Q1B USP, water SIFsp, ph USP, water SIFsp, ph Time (min) Time (min) Q1A and Q1B both fulfill the Q limit 13

14 Q3: Amoxicillin Tablets 250mg, Alkem 14

15 Q3: Amoxicillin Tablets 250mg, Alkem 15

16 Q3: Organoleptic Properties Presence of drug in the sample was confirmed by TLC Chewable tablet questionable dosage form for an antibiotic Description: red tablets without any imprint, strong strawberry smell Product not mentioned in the list of products manufactured by Alkem Laboratories Ltd. in its official website! Counterfeit 16

17 Q3: Uniformity of Content Tablet Tablet % API Mean SD Tablet Tablet Tablet Tablet Failed 17

18 Q3: Dissolution Q3 is a chewable tablet No dissolution tests were performed 18

19 Q4: Amoxycare 500mg, Selfcare 19

20 Q4: Amoxycare 500mg, Selfcare 20

21 Q4: Organoleptic Properties Presence of drug in the sample was confirmed by TLC Hard gelatine capsule Description: red cap and yellow body with randomly #500 and AMOXI imprinted on the capsule halfes; free flowing yellowish/white powder The labeled distributor (Bodiam International Pty Ltd) was found to be non-existent (Internet survey). This was confirmed by the Australian Authorities Counterfeit 21

22 Q4: Uniformity of Content Tablet Tablet % API Mean SD Tablet Tablet Tablet Tablet Failed 22

23 % Drug dissolved Q4: Dissolution USP, water SIFsp, ph Time (min) Q4 fulfills the Q limit of 80% dissolution in 60 min 23

24 Q5: Amoxicillin 500mg, Chemcare 24

25 Q5: Amoxicillin 500mg, Chemcare 25

26 Q5: Organoleptic Properties Presence of drug in the sample was confirmed by TLC Hard gelatine capsule Description: red cap and grey body with a symbol and PHARMAWEALTH imprinted; free flowing yellowish/white powder During preparation for dissolution testing it was observed that one of the blistered capsules was empty Substandard or counterfeit 26

27 Q5: Uniformity of Content Tablet Tablet % API Mean SD Tablet Tablet Tablet Tablet Failed 27

28 % Drug dissolved Q5: Dissolution USP, water SIFsp, ph Time (min) Q5 contains wrong/inconsistent amounts of the API (but complies with the other quality tests) 28

29 Q6: Amoxicillin 250mg, Chemcare 29

30 Q6: Organoleptic Properties Presence of drug in the sample was confirmed by TLC Hard gelatine capsule Description: red cap and yellow body with no imprints; sticky yellowish/white powder; brittle capsule shells 30

31 Q6: Uniformity of Content Tablet Tablet % API Mean SD Tablet Tablet Tablet Tablet Failed 31

32 % Drug dissolved Q6: Dissolution USP, water SIFsp, ph Time (min) Q6 contains inconsistent amounts of the API and has inappropriate visual properties Q6 fulfills the Q limit of 80 % in 60 min 32

33 Conclusion Evaluation of amoxicillin samples showed that the problem of counterfeiting and substandard products in PNG is alarming A stringent regulatory system has to be implemented if this problem is to be controlled and kept in check The above can be achieved by implementing drug registration by the government 33