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Nuevas formas de cristal de ácido minodrónico


Oferta Tecnológica
Una pyme italiana del sector farmacéutico ofrece una nueva tecnología para la síntesis de una nueva forma pura y estable de ácido minodrónico, empleado actualmente en la lucha contra la osteoporosis. El ácido minodrónico es uno de los componentes químicos empleados en la actualidad para preparar productos farmacéuticos que retarden la osteoporosis. La incorporación de una base orgánica facilita la disolución de ácido minodrónico en agua. Las principales ventajas son la preparación sencilla, estabilidad térmica, resistencia a la humedad y alta pureza. La empresa busca socios con el fin de establecer acuerdos de licencia y fabricación.


New crystal forms of Minodronic acid
An Italian SME, active in the pharmaceutical sector is offering a new technology for the synthesis of a new pure and stable form of Minodronic acid, today used to fight osteoporosis. Licence and manufacturing Agreements are the cooperations envisaged by the company.
The proposing company is an Italian SME with cutting edge experience in setting up new procedures for the preparation of pharmaceuticals according to the requirements coming from big pharmaceutical groups.
The Minodronic acid is one of the chemical components used today for the preparation of pharmaceuticals able to slow down osteoporosis. This new technology allows to sythesise a stable crystal form of this acid characterised by high purity and other good characteristics for the parmaceutical industry.
A procedure is here described for producing Minodronic acid with high efficiency and a very high level of chemical purity.
For this purpose, Minodronic acid, synthetized according to procedures known in the state of the art, is dissolved in 6M HCl. After the addition of NaOH up to pH 1, the product precipitates and can be collected by simple filtration, avoiding the necessity to distill a large amount of water, distillation needed in the absence of NaOH.
Moreover, the solid obtained in the step above is re-dissolved in hot 6M HCl and precipitated with methanol, allowing a solid filtration and drying process easier than the onesusing the sodium salt.
Finally, it is here demonstrated that the addition of an organic base allows an easy dissolution of Minodronic acid in water. In particular, the use of equivalents of diethyl-amine enables the dissolution of Minodronic acid at room-temperature. The product can then be re-precipitated, as free acid, by the addition of 1M HCl, affording the product with 99.5% purity measured by High Performance Liquid Chromatography (HPLC).
Two novel crystal forms of Minodronic acid were produced, with unexpected favourable chemical-physical characteristics.
The proposing company has a strong know how in chemical and pharma compounds but does not directly deals with the production. For this reason, licence and manufacturing agreements are searched with larger companies in the pharmaceutical sector.
Advantages and Innovations:
The main advantages are: easy preparation, thermal stability, humidity resistant and high purity.
The Minodronic acid, subject of the present invention, is a thermodynamically stable non-hygroscopic crystal form, characterised by high level of chemical purity as well as good handling characteristics for the preparation of pharmaceutical compositions.
The stability was determined comparing its diffraction pattern with that of the standard reference Minodronic acid showing the same stability of the standard form.
The sample analyzed also shows a hydrophobic behavior and is stable under stress conditions, such as exposure for 7 days at 40°C and 75% Relative Humidity. The X-ray diffraction patterns (XRPD) recorded after 1,3 and 7 days show that the crystal form did not change at all.
The HPLC purity profile demonstrates that Minodronic acid can be produced with a purity, > 99.97%.
Stage of Development:
Under development/lab tested
Granted patent or patent application essential

Partner sought

Type and Role of Partner Sought:
Medium/large companies in the pharmaceutical sector interested in acquiring and using the described patented technology.


Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
Languages Spoken:


Restrict dissemination to specific countries:
Canada, Czech_Republic, Denmark, France, Germany, Ireland, Italy, Malta, Netherlands, Russian Federation, Spain, Switzerland, United Kingdom, United States


Technology Keywords:
06001015 Productos farmacéuticos / medicamentos