Innovation, research and development have been IBSA’s main features since the new ownership took over in 1985, giving a ‘breaking new ground’ attitude to the company.
In all its therapeutic areas (reproduction and fertility, respiratory, rheumatology, urology, pain/inflammation, dermatology and dermocosmetics, endocrinology) and throughout its history, IBSA has been adopting the strategy of optimizing the use of active ingredients for developing innovative pharmaceutical forms capable of improving patient compliance.
In particular, IBSA has been committed in the research of new technologies for the implementation of products containing the following molecules:
In the area of “Pain/Inflammation”, besides the development of different formulations containing the new salt of diclofenac, diclofenac epolamine, which is highly effective as both an anti-inflammatory and an analgesic agent for its favourable permeation characteristics , IBSA has recently enriched its pipeline with the development of a new formulation of diclofenac injectable. The new formula contains diclofenac sodium together with ciclodextrins. These complexing agents, which improve the solubility of diclofenac in the formulation, have led to the creation of a new pharmaceutical form in 1-ml volume which offers not only the unique advantage of the subcutaneous administration (besides the “classical” intra-muscular injection) but also the use of the lowest dosage. Moreover, the availability of different dosage allows to have a treatment which can be customized according to the patient’s conditions. Please refer to the therapeutic area Pain & Inflammation
Human reproduction has always represented for IBSA a committing challenge and a main investment area, that is why it is here that the word innovation has been making a real difference. Currently the company has dedicated plants where the unique and patented process for the purification of pituitary and placental gonadotrophins from human donor takes place. The three main hormones which are used in the therapy for infertility (hFSH, hMG and hCG) are extracted and purified following the highest quality standards. As to hFSH, in particular, IBSA has been challenging new frontiers in terms of research and technology, developing a one and only method for preserving the natural features of the hormone which does not alter the intrinsic structure of the molecule; thanks to this unique procedure, the chemical bonds between glycoproteins and sugars which build up the protein are maintained, creating a human-type drug product having no equal.
Hyaluronic Acid (HA) is a molecule which is naturally present in great quantity in the human body, especially in the eyes, joints and skin, and in the last few years it has become widely used for several conditions: osteoarthritis, skin injuries of different nature, eye surgery, respiratory diseases, interstitial cystitis and many others. IBSA in a partnership with Altergon Italia has implemented the production of a high quality HA. In its modern biotechnological unit, HA is obtained using the cell strain of Streptococcus equi, following an innovative multi-step process which includes fermentation, filtration and purification up to packaging. An innovative methodology in compliance with the highest quality standards to obtain a highly purified product that guarantees the excellent tolerability of IBSA HA-containing products.
Designed expressly for Tirosint® soft gel caps, IBSA’s patented PEARLtec®(Precision Encapsulation technology for the Application and Release of a Liquid formulation) manufacturing system represents a milestone advancement in a field that has been at a standstill for several years. A rotary die encapsulation process enables PEARLtec® to dissolve the caps’ delicate L-T4 active ingredient in a liquid formulation. The innate homogeneity of this solution ensures reliable batch-to-batch consistency and eliminates the need for surdosage even for the lowest strength (13 mcg dose). As well as guaranteeing the benefit of precise formulation, the PEARLtec® system prevents heat-related degradation and deactivation of L-T4 during the compounding process, keeping it from having to be finely ground or heated as in tablet manufacturing. Shielded and safeguarded by two protective levels, the soft cap of levothyroxine ensures excellent stability even long after production. While a core “solid solution” of glycerol and gelatin immobilizes its levothyroxine active ingredient, an outer film of solidified gelatin protects it from harmful rays, oxygen, moisture and micro-contaminants, further reducing variability.
An absolute breakthrough as well as an invaluable contribution implemented by IBSA in the fertility field is Progesterone administered as a watery solution: for the first time ever this adjuvant therapy for pregnancy can be administered subcutaneously, representing this way a good alternative to the painful intramuscular injections or the annoying vaginal applications. Thanks to the association of progesterone with cyclodextrins, it is possible to obtain a suspension of this hormone in a watery solution which results in a non-oily component that is then possible to administer subcutaneously.
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