From the R&D of IBSA Farmaceutici, two new dosage forms of vitamin D to support the treatment of bone metabolism

Ease of use, dosing accuracy, excellent palatability, support for greater therapeutic adherence: these are the key words to describe the advantages of the new dosage forms of vitamin D – in orodispersible film and soft capsules – developed by IBSA Farmaceutici and now available to patients.

Vitamin D is a key molecule for the proper functioning of bone metabolism, especially in menopausal women and the elderly. Indeed, the bone is a “living tissue”, subject to a hormonal endocrine regulation based on the constant balance between calcium and vitamin D levels. When this metabolism is unbalanced, due to an insufficient supply of vitamin D, bone fragility occurs, a condition that weakens the bones, making them more exposed to the risk of fractures, even after minimal traumas. The World Health Organization (WHO) has repeatedly drawn attention to this disease and the related fragility fractures, which have significant consequences both in terms of mortality and motor disability, with high healthcare and social costs. In Italy, this condition affects approximately 5 million people, of whom 80% are post-menopausal women, a proportion inevitably bound to increase, due to the aging of the population. In order not to burden the national health service, a careful prevention is therefore required, as well as – in case of disease – a correct diagnosis and therapies that facilitate adherence to treatment by patients.

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For these reasons, the new dosage forms for the intake of vitamin D – the result of the Research and Development efforts of IBSA Farmaceutici – can play a critical role in regulating calcium metabolism while preserving bone health, and can be very useful tools to overcome certain factors that interfere precisely with adherence to therapy, which today is very low, with around 20-30% of patients discontinuing it early. In general, it is estimated that vitamin D deficiency affects 80% of the Italian population: to ensure its correct levels throughout the year, neither the dietary intake nor exposure to the sun are often sufficient, therefore the formulations in orodispersible film and soft capsules can be of great help to many patients.

All this, and much more, was discussed during a press conference – held in the setting of the Palazzo dei Giureconsulti in Milan – which engaged several experts in an intense and interesting debate: Jacopo Chiodini – President of Società Italiana dell’Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro (SIOMMMS, Italian Society of Osteoporosis, Mineral Metabolism and Skeletal Diseases); Claudio Cricelli – President of Società Italiana di Medicina Generale e delle Cure Primarie (SIMG, Italian Society of General Medicine and Primary Care); and Mario Sfrappini – President of Federazione Italiana Osteoporosi e malattie dello Scheletro (FEDIOS, Italian Federation of Osteoporosis and Skeletal Diseases).

Particular importance was given to two specific issues: prescriptive appropriateness for different categories of patients and compliance with chronic treatment. An appropriate therapy should first of all correct modifiable risk factors: this means recommending more physical activity, a correct nutrition and alcohol and smoking cessation. It is also necessary to correct any deficiency of calcium or vitamin D, the supplementation of which is now a cornerstone of the treatment of bone fragility and osteoporosis. Note 96 – issued by the Italian Medicines Agency (AIFA, Agenzia Italiana del Farmaco) – gives precise indications in this regard, depending on patients’ conditions: in hospitalised patients, pregnant and breastfeeding women and people with osteoporosis who are not candidates for remineralising therapy vitamin D is prescribed regardless of blood dosage, while for other categories the level of hypovitaminosis D should be assessed. For example, the Note indicates a 30 ng/mL threshold for people with osteoporosis who are candidates for remineralising therapy, for whom it is important to correct the vitamin D deficiency before starting treatment.

Also closely related to this aspect is the compliance with chronic treatment issue, which is particularly problematic, because the treatment is often neglected or discontinued by patients for several factors, some of which are of a very practical nature: the therapeutic options available to date have shown some criticalities or difficulties of use, such as the precise counting of the drops, the unpleasant taste of the oily formulations, the packaging in vials often difficult to open. And it’s precisely in this context that the far reaching innovation of the two forms of administration developed by IBSA fits: convenient to use, precise in dosage and with a better palatability, they can improve therapeutic adherence, also by not interfering with the digestive processes and releasing the user from any pre- and post-meal waits, to the advantage of their ease of use. Furthermore, the orodispersible film has the plus to allow easier oral intake even for those with swallowing difficulties, such as children and the elderly.

A demonstration of how IBSA’s innovation is always at the service of patients, starting from listening to their needs and being able to find therapeutic solutions closest to their therapeutic requirements.