Financed by FEDER and CDTI promoters of Research, Technological Development and Innovation in Spanish companies.

(IDI-20190152, November 2018 – December 2020)

 

>> The pharmaceutical laboratory continues its commitment to the line of development of pharmaceutical products in soft gelatin capsule

>> The commercialization of this new generic drug will mean greater patient accessibility to this drug due to its lower cost, which is approximately 40% cheaper than its brand name counterpart.

 

The HC Clover PS pharmaceutical laboratory, specialized in the soft gelatin capsule form through the brand name Aplicaps by Clover, is working on the development of a generic line of medicine directed towards women’s health and specifically focuses on postmenopausal osteoporosis. In this way, the laboratory continues to focus on the line of development of pharmaceutical products in soft gelatin capsules, which generate the technological and innovative difference.

Notable is the co-financing, close to 900,000 euros, received by HC Clover PS SL from the Center for Industrial Technological Development, Public Business Entity (CDTI – EPE), under the Ministry of Science and Innovation and the European Regional Development Fund (ERDF), which promotes, under the motto “A way of making Europe“, the technological development, innovation and quality research of Spanish companies. This financing has been granted for the realization of project IDI-20190152 (Execution period: November 2018 – December 2020), which encompasses the “Development and validation of a highly efficient innovative methodology for the extraction and analytical characterization of the selective modulating API of the estrogen receptor (SERM), formulated in a soft gelatin capsule”, that is, the development of the new generic drug related to postmenopausal osteoporosis.

 

 

The development of this project is carried out at the company’s facilities located in Arganda del Rey (Madrid).

The results obtained so far, in terms of bioequivalence and stability, are promising and give a glimpse of the end of development of the new generic successfully at the end of this year.

The commercialization of the new generic drug will mean greater accessibility for patients to this drug due to its lower cost, which is approximately 40% cheaper than its brand-name counterpart, favoring its consumption and access by the population with less purchasing power.

On the other hand, the development of this generic in a soft gelatin capsule makes it possible to broaden the population spectrum to which it is directed due to the absence of excipients with common allergens in the formulation of oral pharmaceutical forms, as is the case, for example, of the tablet. This factor greatly limits the target population to which the patented drug is directed since it is estimated that between 30 and 50% of the population is intolerant to this type of excipients.

This work path, focused on products of high therapeutic value, will allow HC Clover PS to be positioned as a strategic partner for its clients and obtain highly innovative products and processes. “All this translates into a technological leap in the pharmaceutical sector that will open its doors to its participation in new projects, consortiums and international R&D programs; which will boost the company and position it as a benchmark in the manufacture of drugs in soft gelatin capsules, “says Angela Rincón Arias, head of Basic Research at HC Clover PS.

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