SUMMARY
Objective: To show the benefits of probiotic microorganisms on health and their acceptance by the consumer, as well as to make a compilation of all the probiotic products available in the pharmaceutical market.
Material and methods: A pharmaceutical market study was carried out in relation to the pharmaceutical forms with existing probiotic microorganisms and their evolution in recent years. The classification of all the probiotic products was carried out according to the pharmaceutical form in which they are presented, each product will be accompanied by the dose of probiotic microorganisms it contains, expressed as Colony Forming Units (CFU).
Results: The number of isolated probiotic strains and the benefits shown on the health of man is increasing. We found a great diversity of probiotic products available in pharmacies as a consequence of a growing demand from the consumer; however, it is worth highlighting the fact that many of them lack the necessary information in the container, for example, the dose contained.
Conclusions: The interest on the part of the pharmaceutical industry in lazar new pharmaceutical forms contained in probiotic microorganisms will be increasing and will be linked to the need for a specific regulation for these products. Many of them do not contain the minimum dose required to obtain a beneficial effect on health which is a misleading advertising for the consumer, therefore, should be withdrawn from the market, only advertising those containing a therapeutic dose and whose effects are endorsed by different clinical trials.
Shaklee Optiflora® DI probiotic for Digestive and Immune Health 30 Capsules
Key words: Health benefits, Pharmaceutical presentations, Probiotics.
ABSTRACT
Aims: Show the benefits of the probiotic microorganisms on health and its acceptance by the consumer. As well as collect those probiotic products available in pharmaceutical market.
Materials and methods: A study of the pharmaceutical market in relation to the existing dosage forms with probiotic microorganisms and their evolution in recent years was made. Classifying probiotic products was conducted according to the dosage form in which they are presented; Each product must be accompanied by the dose of probiotic-containing, expressed as Colony Forming Units (CFU).
Results: It is increasing the number of probiotic strains isolated and the benefits that are shown on human health. We found a diversity of probiotic products available in pharmacies as a result of increasing demand by consumers; it is important to note that many of them lack necessary information on packaging, for example, the dose contained.
Conclusions: The interest of the pharmaceutical industry in developing new dosage forms contained in probiotic microorganisms will be related to the need for a specific regulation for these products. Many of them do not contain the required dose to obtain a beneficial effect on health which is misleading advertising to consumers, therefore, they should be removed from the market, advertising only those products which contain a therapeutic dose and whose effects are endorsed by various clinical trials.
Introduction
Since time immemorial has been attributed to microorganisms a predominant role in the environment of our lives, forming part of all the ecosystems in which we move daily and exercising important work in our body. In 1908, Elia Metchnikoff postulated for the first time the importance of the consumption of fermented milk with the Lactobacillus species in the longevity of the Balkan shepherds, by suppressing the putrefactive bacteria of the intestinal microbiota. Currently, after numerous redefinitions, FAO / WHO (2001) defines probiotic as " living microorganisms that confer a beneficial effect on the health of the host, when administered in an adequate amount ". This amount varies from one country to another according to its legislation; however, generally a probiotic product should contain> 10 6 - 10 8 CFU / g or> 10 8 - 10 10 CFU / dose of viable cells 1 . In addition, probiotics are defined as safe according to the English acronym "GRAS" ("generallyrecognized as safe").
The scientific advances of recent years regarding the correlation between the human microbiota and the health status of the individual support the need for them. There are numerous authors who try to demonstrate the beneficial effects of these microorganisms on different pathologies, such as:
- - Diarrhea: infant 2 , diarrhea associated with antibiotics 3 , traveler's diarrhea 4 .
- - Inflammatory bowel disease (IBD): ulcerative colitis 5 and Crohn's disease 6 .
- - Lactose intolerance 7 .
- - Gastroduodenal ulcer 8 .
- - Respiratory tract infections 9 .
- - Reduction of cholesterol levels 10; 11 .
- - Effects against obesity 12 and diabetes 13
- - Allergies 14; 15 , skin diseases and eczema 16 .
- - Cancer 17 .
- - Vaginitis and urogenital diseases 18 .
The commonly used probiotic strains belong to the genera Lactobacillus, Bifidobacterium, E.coli Nissle 1917 and Saccharomyces boulardii. Not all probiotics have the same beneficial properties. In addition, when a beneficial effect is ascribed to a strain, it can not be extrapolated to the remaining strains of the same species. Clinical trials have been conducted using different strains and formulations, obtaining as a final conclusion that not only the specificity of the strain or the location of the target disease must be taken into account; but the dose, route, duration and frequency of administration should also be carefully considered 19 . Thus, to obtain health benefits, a dose of 5 billion colony forming units (CFU) is recommended for at least 5 days (5x10 9 CFU / day) 20 . Since the main route of administration of probiotic microorganisms is the oral route, in order to provide these beneficial effects in the host, the probiotic bacteria must survive throughout the gastrointestinal tract, tolerate acid, bile and enzymes at the same level. gastric and, subsequently, adhere to the intestinal epithelium 21 ; that is why they must be administered in pharmaceutical forms or in foods that give protection against these adverse conditions. These probiotic products must also guarantee the survival of microorganisms in a viable manner during storage until the end of shelf life (> 10 6 CFU / g) 22 . The commercial interest of probiotics is gradually increased, as advances are made in the knowledge about the relationship between them and the intestinal microbiota, their interaction and the unleashing of a series of positive effects on the individual, therefore, they open a very hopeful alternative both in the field of functional nutrition and in the improvement and prophylaxis of certain pathologies.
Therefore, the main objective of this work has been to carry out an exhaustive review of the pharmaceutical forms carrying probiotic bacteria existing in our country, as well as their advantages, disadvantages, doses and effectiveness.
Materials and methods
In the first place, it is intended to analyze the evolution and relevance of probiotic products in the pharmaceutical sector during the last years, as well as the expected demand for future times. To this end, the Web pages PubMed , ScienceDirect and the electronic journal El Probiotic were used as the main sources for the search of the most interesting research papers published on the subject. On the other hand, a market study was carried out, in order to specify all those pharmaceutical modalities that can be found in pharmacy offices available to the consumer. For this, the information provided by the Medication Information Center was essential, contrasted with the data provided by the laboratories involved. The information obtained was carefully analyzed, highlighting the most relevant results regarding the development of new pharmaceutical forms with probiotic microorganisms and their requirements.
Results and Discussion
The growing market interest in promoting health naturally has intensified research in this area. A recent global analysis of the probiotic market estimated an annual growth of 7%, driven mainly by an increase in demand from Asian and European consumers, with a forecast of 48 trillion dollars over the next 5 years (GlobalIndustryAnalysisReport 2012) . Likewise, we can find probiotics under different pharmaceutical modalities such as oral administration pharmaceutical specialties, dietary supplements, oral rehydration solutions, infant formulas and specialties for urogenital use; as well as included in a wide variety of foods. While these foods are related to the maintenance of the normal functioning of the organism or to the reduction of the risks of disease in a large population center, both healthy and not so healthy; Pharmaceutical modalities are considered as a primary therapeutic solution in a specific disease situation 23 .
As we can see, most of the products sold are in the form of capsules or envelopes while the available tablets are minimal. The lack of tablets with probiotics and the overlap with other pharmaceutical forms, mainly capsules, has been detrimental to the dose of bacteria administered by pharmaceutical form, which should be sufficient to generate a satisfactory effect on the health of the patient. Thus, the technological conditions used to obtain capsules are less aggressive, therefore, the survival of the bacteria will be very high and will allow a lower production cost. On the contrary, compression requires high pressures that entail the loss of a large part of the bacteria.
However, there are multiple advantages that tablets give us and not capsules, such as allowing us to achieve a controlled or modified release of the active ingredient. In recent years, research in the design of pharmaceutical forms has focused on the search for systems that allow controlling the time, place and speed of release of the active ingredient after its administration. The reasons, among others, derive from the desire to achieve the prolonged release of highly water soluble compounds, achieve release rates that respond to a given objective, decrease the number of daily administrations and minimize side effects. For this reason, the design and development of probiotic tablets that suppose a great innovation in the sector and that provide a control in the release of the probiotic content is considered as a center of future research.
The availability of probiotic microorganisms in a wide variety of foods, food supplements and pharmaceutical specialties is providing changes for the consumer and health personnel regarding the choice of the optimal product for an adequate application in the indicated person.
The main problem associated with the trade of these products lies in the lack of sufficient information in the labeling of many of them (UFC / uda / g, strains contained, clinical trials conducted to support their effectiveness ...) this being a reason for distrust by the consumer about the health benefits they offer. The interest on the part of the Pharmaceutical Industry in the development of new specialties containing probiotic microorganisms should be linked to the establishment of a regulation for them in order to present that associated information available to the consumer.
conclusion
Based on the foregoing, it seems clear that the use of probiotic microorganisms as health enhancers is a promising tool in the advancement of various fields such as food or pharmaceutical and thus the need to develop new pharmaceutical specialties and other products carriers of the same. The success of these microorganisms depends on the medium used to administer them, which is why it should be emphasized the importance of pharmaceutical forms in ensuring the protection of these microorganisms at all times allowing the arrival of these in a sufficient number to the place of action. Only in this way will it be possible to obtain positive effects on consumer health, since a dose of at least 5 billion colony-forming units is recommended for at least 5 days (5 x 10 9 CFU / day).
As mentioned above, the demand for these probiotic products is on the rise, which poses a challenge for the pharmaceutical industry, which should select those technological processes and production conditions appropriate to solve the problems associated with the sensitivity of these probiotic microorganisms; finally guaranteeing an optimal dose in each pharmaceutical form. The development of innovative pharmaceutical forms should be considered, which represent an advance in this area, in order to control the release of the contained probiotic load.
However, a specific regulation is needed that establishes safety, dose and labeling parameters. Regulation on nutrition and health issues in Europe is expected to help bring order to product claims, although it should not impede development and innovation in the sector; should eliminate from the market those products that do not comply with the definition or that claim unsubstantiated health benefits, allowing pharmaceutical products to obtain the recognition they deserve, based on research carried out.
Thanks
We want to express our gratitude to the Pharmacy Josefina Tarifa, La Rábita (Granada) for the help given in the achievement of this work.