Investing in new formulations means embarking on a journey fraught with risk.
the history of IdiPharma and its innovative micronized product
which offers a significant increase in bioavailability.
Other articles about micronization:
Investing in new formulations is like embarking on a perilous journey, with the hope of reaching a destination that is a new supplement with a significant and measurable impact on people’s health. Unfortunately, the chances of getting lost and never reaching the goal are high. The difficulties start already during the very early stages of development, for example, it is already a challenge to find excipients that have the desired technological characteristics and that are at the same time compatible with the active ingredients and compliant with the regulations of the supplements.
Despite the numerous difficulties, developing new formulas for food supplements is possible.
One example is the story of IdiPharma srl, an Italian company specialized in the sector of urological and gynecologic supplements, which was able to develop an innovative micronized product that offers a significant increase in the bioavailability of myo-inositol, a widely used supplement for the treatment of polycystic ovary syndrome. As reported in the study published in the International Journal of Molecular Sciences.
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International Journal of Molecular Sciences
Myo-Inositol: A Precious Ally for Health
Myo-inositol is a compound naturally present in some foods, such as fruits, vegetables, and whole grains. However, its oral bioavailability, or the amount of nutrient actually absorbed by the body, is often limited. Myo-inositol is particularly appreciated for its role in hormone regulation, glucose metabolism, reproductive health, and especially polycystic ovary syndrome (PCOS). The amounts taken with the diet are often not sufficient to meet the needs of those suffering from PCOS. Taking myo-inositol in supplement form could therefore help regulate hormone levels, improve insulin sensitivity, and reduce PCOS symptoms.
The Problem:
Given its limited bioavailability, even supplements suffer from the same problem as myo-inositol present in food, that is, a large part is not absorbed by the body and is lost.
The Challenge: Increasing Myo-Inositol Absorption
To increase the absorption of myo-inositol, IdiPharma carried out a complex innovation and industrialization project, which rewarded the company with a new micro-delivery system based on an anionic methacrylate copolymer, capable of improving the biological response of myo-inositol through daily oral administration. The new micronized supplement is better than the traditional formulations used in chronic therapy for the treatment of polycystic ovary syndrome. In fact, the new micronized supplement has shown a 150% increase in bioavailability compared to non-micronized myo-inositol. This means that the body is able to absorb a significantly greater amount of myo-inositol when it is taken in the form of the microparticles developed in this project.
The development project in Detail
The project was divided into three phases: formulation planning, prototyping, and efficacy verification. The result was a micronized myo-inositol product produced by spray-drying and with a particle size controlled to less than 15 μm. The dosage form obtained in this way is a free-flowing and dry powder. The product is ready for administration in sachets, or ideal for further processing for the production of tablets or capsules.
We at Technology Scientific were responsible for all development activities from formulation design to prototyping and efficacy verification. In our laboratories we have seen the generation of different prototypes of micronized supplements. For each of these, the in vitro release profile with pH jump and ex vivo intestinal mucosal permeation on pig intestine were studied. Finally, we observed how the best of these prototypes was able to increase, in an in vivo evaluation, the AUC and Cmax of myo-inositol loaded in the micronized supplement, which were increased by at least 1.5 times compared to the pure substance, administered at the same dose and by the same route. in an in vivo evaluation. The in vivo evaluation was carried out on a rat animal model to demonstrate that the bioavailability of myo-inositol increased compared to the administration of the same dosage of pure myo-inositol. Finally, we observed how the new micronized supplement was able to increase the levels of myo-inositol in the ovarian follicles, confirming that daily administration of the new formulation improves the concentration of myo-inositol at the site of action, with an improvement of about 1.25 times for the single administration and 1.66 times after 7 days of repeated administration compared to pure Myo-inositol.
The Results:
The experimental study evaluated the efficacy of spray-dried myo-inositol microparticles compared to traditional myo-inositol. The results showed that:
- Myo-inositol microparticles had significantly higher bioavailability, in terms of AUC, compared to traditional myo-inositol.
- Myo-inositol levels in the blood were higher and more lasting over time with microparticles.
- Study participants reported an improvement in PCOS symptoms with microparticles.
Conclusions
The story of IdiPharma and its new micronized supplement clearly demonstrates how innovation projects, despite the risks, can be transformed into a success story if planned competently and executed rigorously.
Finally, the potential of spray drying micronization in the supplement sector also emerges, capable of producing more effective products with superior bioavailability.
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