Les Laboratoires Servier has been granted a patent for a pharmaceutical composition that combines palbociclib tosylate and letrozole in one dosage unit. The composition ensures that the particles of both active ingredients are not separated from each other. The patent also covers the production of the pharmaceutical preparation, the use of the preparation, and a special blister packaging that facilitates a specific dosage regimen. GlobalData’s report on Les Laboratoires Servier gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Les Laboratoires Servier, cancer treatment biomarkers was a key innovation area identified from patents. Les Laboratoires Servier's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Pharmaceutical composition comprising palbociclib tosylate and letrozole
A recently granted patent (Publication Number: US11672804B1) discloses a pharmaceutical composition comprising the 4-toluenesulfonic acid salt of palbociclib and letrozole. The composition is not limited to the isolated forms of the salts and can include homogenized mixtures. The patent also describes the characteristic X-ray powder diffraction peaks of the 4-toluenesulfonic acid salt of palbociclib. The composition can contain 10 to 50% by weight of palbociclib tosylate salt and 0.10 to 1% by weight of letrozole. It may also include additional excipients such as fillers, binders, disintegrants, lubricants, and glidants. The composition can be in the form of granules or tablets, with the tablets optionally coated.
The patent also discloses a process for preparing the pharmaceutical composition, which involves homogenizing the salts with letrozole and other excipients, followed by granulation and addition of further excipients. The resulting mixture can be filled into capsules or tableted, with the tablets optionally coated. The patent further describes a fixed-dose combination composition containing the salts of palbociclib and letrozole, which can be packaged in blister form. The secondary packaging can include blisters containing the fixed-dose combination composition as well as blisters containing a mono composition of letrozole. Various arrangements of the blisters are described, including those with markings indicating the time or order of taking the doses. The patent also provides specific ranges for the amounts of palbociclib tosylate salt, letrozole, and other excipients in the composition.
Overall, this patent discloses a pharmaceutical composition comprising the 4-toluenesulfonic acid salt of palbociclib and letrozole, along with methods for preparing the composition and packaging it in blister form. The composition can be in the form of granules or tablets, and can include various excipients. The patent provides specific ranges for the amounts of the active ingredients and excipients, as well as characteristic X-ray powder diffraction peaks for the salt of palbociclib.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
