Some H2 Antihistaminics And Ppi-S Products Authorized In Albania And Their Availability For Pediatric Groups

The objective of this study was to evaluate the number of medicines and active ingredients for pediatric population that are authorized and marketed in Albania. For this purpose were selected two group’s medicines: H2 antihistaminics and Proton Pump Inhibitors. The availability of pediatric medicines and active ingredients was studied with the help of the database of the Albanian National Agency for Medicine and Medical Devices and SmPCs. Selected active ingredients were categorized based on their route of administration, type of pharmaceutical form, dosage, therapeutic indication, dose capability and suitability of the pharmaceutical form for use in children. From evaluation of SmPCs of selected products for the authorized age - group were found that 58 products are also authorized for use in children. Two of the active ingredients are authorized only for use in adults. The analyze of aspect if the recommended dose prescribed based on the classification of pediatric age stated give these data’s: 35 products are authorized for use children and adolescents from 3–18 years and 23 products are authorized for use in children more than 1 year old. This study shows a lack of availability of pediatric medicines for selected products and shows that pediatric medicines may not be age-appropriate; even they are authorized for such use. It was shown that few medicinal products are specifically studied in children. Therefore, are needed more efforts to increase the number of drugs authorized for the pediatric groups. Even more, it is required by pharmaceutical companies to supply data on the effects of new drugs in children

STATISTIC ESTIMATION OF BREAKING TABLETS OF ENALAPRIL 20 MG

Objective: The aim of this study was to evaluate the accuracy of breaking into half and quarter-tablets Enalapril 20 mg sold in the Albanian market, in dosages suitable for use in children.Methods: 100 whole tablets of Enalapril 20 mg were chosen at random from each of three different manufacturers based on scoring characteristic: scored on one side, scored on both sides and not scored. Whole tablets from each of the three product types were weighed and the mean weight calculated. The pills were then split in half and quarter by using a pill-splitter. The resulting half-tablets and quarter-tablets were weighed and the mean weights were calculated.Results: All the whole tablets were found to conform to the set criteria. Only halves from those tablets scored on both sides passed the weight uniformity test, with no individual half outside the 85-115 % range. Quarter-tablets failed the weight uniformity test. A higher relative standard deviation was observed for half and quarter-tablets of the not-scored tablet.Conclusion: The study shows that deviations in weight were observed in half tablets and quarter tablets of Enalapril 20 mg. These deviations were related to the presence or not of the score line. Such inadequate breaking of the tablets may result in dose variability and complicate therapeutic outcome.Keywords: Enalapril, Breaking tablets, Pediatric formulations, Score lin