Probiotics are increasingly more present both as functional foods, and in pharmaceutical preparations with multiple levels of action that contribute to human health. Probiotics realize their positive effects with a proper dose, and by maintaining a declared number of probiotics cells by the expiration date. Important precondition for developing a probiotic product is the right choice of clinically proven probiotic strain, the choice of other active components, as well as, the optimization of the quantity of active component of probiotic per product dose. Optimal quantity of active component L. plantarum of 50 mg, was selected. The purpose of this scientific paper is to select the optimal formulation of probiotic culture in a dietary supplement that contains iron and vitamin C, and to also determine its expiration date by the analysis of the number of viable probiotic cells.

Insomnia means difficulty in falling asleep and/or stays asleep. Insomnia commonly leads to daytime sleepiness, lethargy, and a general feeling of being unwell. The most common treatment of insomnia includes GABAA receptor positive allosteric modulators or Melatonin agonists. Our study aimed to evaluate the efficacy of Magnesium- melatonin-vitamin B complex supplement in the treatment of insomnia. The study included 60 patients diagnosed with insomnia. The patients were randomly divided into study group (N = 30), and control group (N = 30), and study group was treated with Magnesium-melatonin-vitamin B complex (one dose contains 175 mg liposomal magnesium oxide, 10 mg Vit B6, 16 μg vit B12, melatonin 1 mg, Extrafolate-S 600 μg) once a day 1 hour before sleep, during the 3 months. The severity of insomnia symptoms was measured by self-reported Athens insomnia scale (AIS), with a cut-off score by Soldatos (AIS score ≥ 6). Mean AIS score at zero points was 14.93 ± 3.778 in the study group and 14.37 ± 4.081 in the control group (p = 0.476), indicating the compatibility of the groups, and both scores correspond to mild to moderate insomnia. Mean AIS score after 3 months of the Magnesium- melatonin- vitamin B complex supplementation was 10.50 ± 4.21 corresponding to mild insomnia, while median AIS score in the control group was 15.13 ± 3.76 which is referred to moderate insomnia, and difference among groups was significant (p = 0.000). Our founding’s indicating that 3 months of the Magnesium- melatonin-vitamin B complex supplementation has a beneficial effect in the treatment of insomnia regardless of cause.

Probiotic pharmaceutical preparations are more and more popular because of the increasing level of evidence of their beneficial effect on human health. The goal of this study was to determine and develop the encapsulated probiotic formulation with the optimal filling amount of active ingredient-Lactobacillus plantarum that would, in combination with other active ingredients: iron, vitamin C and excipient starch, fulfil requirements for therapeutic action while maintaining process parameters' requirements of manufacturing as well. The optimal formulation of a multicomponent probiotic-based formulation that fulfils requirements for sustaining all active ingredients while respecting technological process requirements, will enable a routine pharmaceutical manufacturing that could yield both efficient and safe dietary products.

Quality management is very important segment of business in pharmaceutical industry which primary objective is to provide a quality product to customer for the purpose of preserving human health. The increasing number of companies apply numerous quality systems, hence the need for a comparative review of quality management systems and its optimization in order to find suitable model for the integration of these systems. The improvement of integrated management and quality systems has become an imperative of company's business development and survival. It is economically acceptable to use synergy potential in the field of quality management for the purpose of significantly improving company's business competitive position with a relatively small investment. In addition to this, with the integration of different management systems companies become more agile, profitable and more competitive, which is a condition for its survival on the global marketplace. Integrated management systems combine all the components of management systems into a coherent system thus enabling the achievement of company's policy and goals. Basically, there are three approaches for establishment of integrated quality management systems: the Sequential approach, Parallel approach and Combined approach.

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