Purpose:To evaluate and characterize the wound healing process profile induced by allantoin incorporated in soft lotion oil/water emulsion using the planimetric and histological methods. Methods: Female Wistar rats (n=60) were randomly assigned to 3 experimental groups: (C) control group-without treatment; (E) group treated with soft lotion O/W emulsion excipients; (EA) group treated with soft lotion O/W emulsion containing allantoin 5%. The emulsions either containing or not allantoin were topically administered for 14 days and the wound area was evaluated by planimetry and by qualitative and quantitative histological analysis of open wound model. Results:The data which were obtained and analyzed innovate by demonstrating, qualitatively and quantitatively, by histological analysis, the profile of healing process induced by allantoin. The results suggest that the wound healing mechanism induced by allantoin occurs via the regulation of inflammatory response and stimulus to fibroblastic proliferation and extracellular matrix synthesis. Conclusion: This work show, for the first time, the histological wound healing profile induced by allantoin in rats and demonstrated that it is able to ameliorate and fasten the reestablishment of the normal skin. Key words: Wound Healing. Allantoin. Histology. Animal Experimentation. Rats. RESUMOObjetivo: Avaliar e caracterizar o perfil cicatricial induzido pela alantoína incorporada em uma emulsão óleo/água, sob os aspectos planimétrico e histológico. Métodos: Ratos Wistar fêmeas (n=60) foram agrupados aleatoriamente em três grupos experimentais grupo controle -sem tratamento (C); grupo tratado com emulsão pura (E); grupo tratado com emulsão contendo 5% de alantoína (EA). As emulsões contendo ou não alantoína foram administradas topicamente durante 14 dias e a área da ferida foi avaliada por planimetria e por análise histológica qualitativa e quantitativa em modelo de ferida aberta. Resultados: Na análise planimétrica não foi observado diferenças significativas entre os grupos experimentais. Os resultados da análise histológica sugerem que o mecanismo de cicatrização induzido pela alantoína ocorre via controle da resposta inflamatória e estímulos à proliferação fibroblástica e síntese de matrix extracelular de maneira mais intensa e rapidamente em relação aos grupos controles. Conclusão: Este trabalho mostra pela primeira vez o perfil histológico de cicatrização induzido pela alantoína em ratos, demonstrando ser capaz de melhorar e acelerar o processo de reconstituição da pele. Descritores: Cicatrização de Feridas. Alantoína. Histologia. Experimentação Animal. Ratos.

The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

Objective:to characterize and determine the polypharmacy prevalence in patients with chronic diseases and to identify the factors associated, in order to improvement of pharmaceutical care focused on patient safety.Methods:cross-sectional study included 558 patients, covered by primary health care, using a household and structured questionnaire. We analyzed the data on polypharmacy and its clinical and socioeconomic factors. Poisson regression analysis with robust variance was applied, with results expressed in prevalence ratio.Results:the results showed that polypharmacy (consumption of four or more drugs) was of 37.6%. The prevalence ratio analyses identified independent variables associated with polypharmacy: age (3.05), economic strata (0.33), way of medication acquisition through a combination of out-of-pocket and Brazilian public health system (1.44), diabetes and hypertension (2.11), comorbidities (coronary artery disease 2.26) and hospital admission (1.73). In the analyses, inappropriate medication use of the 278 patients (≥ 65 years) was associated with polypharmacy (prevalence ratio 4.04).Conclusion:polypharmacy study becomes an opportunity to guide the strategies for the patient safety to promote the medication without harm in chronic diseases.

Objective:This study describes the development of the medication history of the medical records to measure factors associated with medication errors among chronic diseases patients in Diamantina, Minas Gerais. Methods:retrospective, descriptive observational study of secondary data, through the review of medical records of hypertensive and diabetic patients, from March to October 2016. Results:The patients the mean age of patient was 62.1 ± 14.3 years. The number of basic nursing care (95.5%) prevailed and physician consultations were 82.6%. Polypharmacy was recorded in 54% of sample, and review of the medication lists by a pharmacist revealed that 67.0% drug included at least one risk. The most common risks were: drug-drug interaction (57.8%), renal risk (29.8%), risk of falling (12.9%) and duplicate therapies (11.9%). Factors associated with medications errors history were chronic diseases and polypharmacy, that persisted in multivariate analysis, with adjusted RP chronic diseases, diabetes RP 1.55 (95%IC 1.04-1.94), diabetes/hypertension RP 1.6 (95%CI 1.09-1.23) and polypharmacy RP 1.61 (95%IC 1.41-1.85), respectively. Conclusion:Medication errors are known to compromise patient safety. This has led to the suggestion that medication reconciliation an entry point into the systems health, ongoing care coordination and a person focused approach for people and their families.

The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic profile and few side effects. Thus, it is also considered by WHO and the International Pharmaceutical Federation (FIP) as a drug candidate to biowaiver, which is the evaluation of how favorable the biopharmaceutics characteristics are in order to obtain waiver from the relative bioavailability/bioequivalence (RB/BE) studies to register new medicines. This paper presents a review about the solubility, permeability and dissolution of gliclazide. A critical analysis of the information allowed to identify gliclazide as a Biopharmaceutics Classification System (BCS) Class II drug. Therefore, new drugs in immediate release dosage forms will not be eligible for biowaiver. Regarding the extended release dosage forms, besides the limited solubility, no information on the comparative dissolution profile was found, which would be necessary to analyze a possible biowaiver for a smaller dosage. It can be concluded that the registration of new medicines containing gliclazide must undergo RB/BE studies, since there is not enough evidence to recommend the replacement and waiver of such studies for immediate and extended release formulations.