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Microchemical Journal.15:83-87. \u2022 Cooperativa Farmaceutica. (1996), Medicamenta \u2013 VII edizione.Milano. \u2022 EDQM, European Directorate for the Quality of Medicines and HealthCare (2017),European Pharmacopoeia, 9th edition.Geneva: Council of Europe. \u2022 EMA web site. EMA scientific guideline on stability for human medicines. \u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587/\u2587\u2587\u2587/\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587?curl=pages/regulation/general/general_content_000361 .jsp&mid=WC0b01ac0580028eb1 (accessed 01/03/2017). \u2022 Encyclopaedia Britannica website. \u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587 (accessed01/03/2017). \u2022 \u2587\u2587\u2587\u2587\u2587\u2587 \u2587.\u2587., \u2587\u2587\u2587\u2587\u2587\u2587\u2587 M.R., \u2587\u2587\u2587\u2587\u2587\u2587 \u2587.\u2587., \u2587\u2587\u2587\u2587\u2587\u2587\u2587 C.A., \u2587\u2587\u2587\u2587 R.E. (2004),Chemical and Functional Analysis of Hydroxyurea Oral Solutions. J PediatrHematolOncol; 26:179- 184. \u2022 \u2587\u2587\u2587\u2587 S., \u2587\u2587\u2587\u2587 \u2587., \u2587\u2587\u2587\u2587'\u2587\u2587\u2587\u2587\u2587 R., De Zen L., \u2587\u2587\u2587\u2587\u2587\u2587\u2587 F., \u2587\u2587\u2587\u2587\u2587 P.(2013). Prevalence of sickle cell disease, hemoglobin S, and hemoglobin C among Haitian newborns, American Journal of HematologySep;88(9):827-8. \u2022 \u2587\u2587\u2587\u2587\u2587 et al. 2011. Associazione Italiana Ematologia Oncologia Pediatrica: raccomandazioni per la gestione \u2587\u2587\u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 drepanocitica in et\u00e0 pediatrica in Italia. \u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587/files/files_htmlarea/pubblicazioni_tiziana/GL/globulo_rosso/docume nti/14.02.2011%20raccomandazioni%20drepanocitosi%20Russo%20rev.%201.pdf (accessed 01/03/2017). \u2022 WHO 2017. Model Lists of Essential Medicines, 20th edition. \u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587/medicines/publications/essentialmedicines/en/ (accessed 01/03/2017). 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"clause", "offset": [6662, 6679]}, {"key": "counterfeit-products", "type": "clause", "offset": [6787, 6807]}, {"key": "in-the-case", "type": "clause", "offset": [6820, 6831]}, {"key": "figure-4", "type": "definition", "offset": [6855, 6863]}, {"key": "distribution-of", "type": "clause", "offset": [6878, 6893]}, {"key": "origin-of", "type": "definition", "offset": [6991, 7000]}, {"key": "drug-samples", "type": "definition", "offset": [7014, 7026]}], "snippet": "A.\u00ae Project is usually performed in different phas- es, detailed on the Web site \u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587. A pre- liminary need of the Project is to determine (through on- site sampling) the average quality of available medicines in the area, to ascertain the percentage of substandard or counterfeit drugs, and to set up a priority list with the most problematic realities on the top. Therefore, a preliminary stability study on the most common and used pharmaceu- tical forms was performed. When the galenic laboratory is set up, the galenics produced in the laboratory are sent to A.P.P.A.\u00ae staff in Turin for a quality check to ensure that a suf- ficient quality level is continuously maintained. The quali- quantitative composition of the analyzed galenics was re- ported in Table 4 (18,20,21). For each galenic dosage form, the complete dosage form and its API was tested. Two different batches of samples were prepared: the first one was prepared 18 months prior to the beginning of the TABLE 4. Quali-quantitative composition of tested galenics prepared in A.P.P.A.\u00ae laboratories into account that Pharmacopoeia (17) does not prescribe a specific analytical method for performing the content uniformity assay (simply stating that a \u201csuitable analytical method\u201d should be applied), we decided to use an UV-VIS spectrophotometric method. This choice was also deter- mined by an opportunity to apply this technique in African countries, where the instruments necessary for HPLC are too expensive. In any case, in order to evaluate the equiva- lence between the two methods, every sample containing amoxicillin, ibuprofen, and paracetamol was analyzed us- ing both HPLC and UV-VIS methods and the results were compared. Stability study Eight galenics were formulated in seven different dosages at the laboratory of A.P.P.A.\u00ae Project, the main project of Aid Progress Pharmacist Agreement, a no-profit organiza- tion proposing to assist the realization of galenic labo- ratories in developing countries around the globe. Active pharmaceutical ingredient Paroxetine Amoxicillin Hydrocortisone acetate Ketoprofen Dextromethorphan hydrobromide Nifedipine Fluoxetine Dosage form Quali-quantitative composition study and stored at \u201cstandard\u201d conditions (as hereinafter de- fined). A second batch of samples was prepared at the be- ginning of the stability study and used as a standard to check the stability of the first batch after 18 months\u2019 storage. All samples of dosage forms (in a sufficient amount to al- low sampling through the whole study) were stored in cali- brated thermostats. Samples of the relative powdered APIs were stored at the same conditions and analyzed in paral- lel with finished dosage forms. Three different conditions of temperature (T) and relative humidity (RH), ie, \u201c\u2587\u2587\u2587\u2587- dard,\u201d\u201caccelerated,\u201d and \u201cstress\u201d conditions, were applied to all samples (31,32). The \u201cstandard\u201d conditions (t = 25 \u00b1 2\u00b0C, RH = 50 \u00b1 5%) were applied to define the stability of \u2587\u2587\u2587- \u2587\u2587\u2587\u2587 under pharmacy storage conditions accepted by the European Pharmacopoeia. \u201cAccelerated\u201d (t = 40 \u00b1 2\u00b0C; RH = 50 \u00b1 5%) and \u201cstress\u201d (t = 40 \u00b1 2\u00b0C; RH = 80 \u00b1 5%) conditions were investigated with a double purpose: to support real-time stability data with the results coming from accelerated storage condi- tions and to obtain information on the expected stability of drugs in tropical climates. For samples stored in \u201cacceler- ated\u201d and \u201cstress\u201d conditions, both polypropylene (PP) and glass containers were used, while samples under\u201cstandard\u201d conditions were stored only in PP containers. Chemical stability both of dosage forms and APIs was eval- uated by a quantitative assay at different time points dur- ing the overall 6-month study period. For \u201cstandard\u201d condi- tions, two sampling time points were foreseen, T0 and T6. For \u201caccelerated\u201d and \u201cstress\u201d conditions, further sampling time points were foreseen on a monthly basis. Both for APIs and dosage forms, 10 samples were analyzed at each time point and the average API concentration was calculated as the arithmetic mean of all values. We took into account \u201cstress\u201d and \u201caccelerated\u201d conditions to gather information on the prospective stability of ga- lenics in extreme environmental conditions (eg, in tropical countries). Eventually, we compared the stability data of galenics stored in PP and glass containers. As foreseen by the pharmacopoeia, samples complied with specifications if the API content was within \u00b110% of the expected value. Analytical method The UV-VIS spectrophotometric assay used to determine the samples stability was the same as described before (17,24,33). In addition, a calibration curve was prepared at \u03bbmax for each API and the concentration in each sample at different time points was calculated using \u2587\u2587\u2587\u2587\u2587\u2587\u2587-Beer\u2019s law (A = \u03b5bc). For the analysis of APIs contained in the dosage forms, a second calibration curve was obtained by using standard solutions prepared mixing API and excipients in the same ratio used for the dosage forms. This was done in order to avoid underestimating the samples concentration due to an incomplete API extraction from the excipients matrix. Blank solutions were prepared by dissolving appropriate amounts of excipients contained in the pharmaceutical forms in suitable solvents. Analytical samples were extract- ed from dosage forms using an appropriate amount of sol- vent and favoring the dissolution with a vortex. After cen- trifugation for 5 minutes at 4000 rpm, supernatants were properly diluted using the same solvent for spectrophoto- metric analysis. Isolated APIs were dissolved in solvent at an appropriate concentration and analyzed directly. RESULTS Counterfeit drugs Central African Republic was excluded from the final evalu- ation due to an insufficient number of samples. Thus, the presented results correspond to 196 samples instead of 221 (Figure 1). The most represented manufacturing coun- try was India (31%), but it is noteworthy that in 56% of the cases it was not possible to determine the manufacturing country (Figure 2). The overall percentages of samples satisfying Pharmaco- poeia assays were the following: general aspect 96%, uni- formity of mass 95%, uniformity of content 75%, disinte- gration 90%, hardness 74%, and friability 85%. Based on these results, it was possible to determine that 50% of test items were substandard drugs and even 2% were counter- feits without the presence of the declared API, ie, criminal counterfeits (Figure 3). Our results also showed that Indian drugs were often substandard: 30 out of 61 Indian samples (ie, 41.7%) showed OOS values. Only for 109 samples out of 221, it was possible to determine whether they were pur- chased in pharmacies (83%) or from unofficial street-phar- macists (17%). The percentage of counterfeit products was greater in the case of street-pharmacists (Figure 4). The overall distribution of counterfeits and substan- dard medicines in different countries showed that FIGURE 1. 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