Active Ingredients: Amoxicillin
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The originator brand of paracetamol in South Africa is Panado R.
For amoxicillin, this is Amoxil R. Both amoxicillin and hydrochlorothiazide, classified as prescription medicines, require a medical prescription when being purchased in South Africa.
Paracetamol can be bought over the counter without a prescription. For this study we obtained our sample of products from sources commonly used by the consumers.
Consumers identified three main sources for medicines: the public sector clinic or hospital, dispensing doctors, and community pharmacies.
For the public sector medicines from eleven clinics and hospitals in Durban, KwaZulu-Natal were procured after permission was granted by the provincial Department of Health. Dispensing doctors in Durban and Johannesburg were approached, told about the study, and asked to provide medicines.
Medicines were supplied by seven doctors, four in Durban and three in Johannesburg.
Medicines were purchased for cash, using prescriptions written by a South African medical colleague, from thirty community pharmacies: eleven in Durban, ten in Johannesburg and nine in Cape Town.
Here the data collector started at a central point in the respective city and went to pharmacies within a 20 kilometer radius until approximately ten sites were visited in a single day to purchase the medicines.
Medicines were supplied in patient-ready packs with the brand decided by the supplier. Twenty-nine generic medicines were sourced from the public sector.
The remaining 106 samples were sourced from the private sector dispensing doctors and community pharmacists. Of these, six were samples of PanadoR and four were samples of AmoxilR, representing innovator brands.
Therefore, out of the total of 135 samples, ten were innovator brands supplied solely by the private sector and the remaining 125 samples were branded and unbranded generics from both the public and private sectors.
Table 3 provides a description of the medicines assessed in this study. Table 3 Description of medicines tested Full size table Several tests can be performed on a medicine to determine its quality; tests for identity, content, disintegration, dissolution, stability, sterility, impurity, bioavailability and bioequivalence as per the monographs in the relevant pharmacopeias.
This study focused on assessing the identity, dissolution and uniformity of weight. Identity testing is crucial because this verifies the active pharmaceutical ingredient.
Fourier transformed infrared spectroscopy FTIR was used to assess the identity of the products according to the monographs of the British Pharmacopeia BP for amoxicillin rehydrate 250 mg and 500 mg capsules, hydrochlorothiazide 25 mg tablets, and paracetamol 500 mg tablets.