HL Mando. has filed a patent for beta-cyclodextrin mixtures with hydroxypropyl groups for pharmaceutical use in treating Niemann-Pick disease Type C. The composition is suitable for intravenous administration, meeting specific criteria for endotoxin levels, propylene glycol content, and propylene oxide concentration. GlobalData’s report on HL Mando 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 HL Mando, Driving behavior monitoring was a key innovation area identified from patents. HL Mando's grant share as of January 2024 was 84%. Grant share is based on the ratio of number of grants to total number of patents.

Pharmaceutical composition for intravenous injection with beta-cyclodextrin

Source: United States Patent and Trademark Office (USPTO). Credit: HL Mando Corp

The patent application (Publication Number: US20240016829A1) discloses a composition designed for intravenous injection, consisting of beta-cyclodextrin molecules substituted with hydroxypropyl groups. The composition is formulated to be pharmaceutically acceptable for intravenous administration, containing less than 2 Endotoxin Units (EU) of endotoxins per gram, no more than 0.5% propylene glycol, and less than 1 ppm of propylene oxide. Additionally, the composition includes sodium chloride at 0.9% w/v, maintains a pH range of 6.0-8.0, and is sterile filtered for purity.

Furthermore, the composition is specified to have a storage temperature range of 15-25°C, with an osmolality of about 300 to 450 mOsm/kg. The mixture of beta-cyclodextrin molecules in the composition is limited to less than 3.5% collectively of unsubstituted beta-cyclodextrin, beta-cyclodextrin substituted with one hydroxypropyl group, and beta-cyclodextrin substituted with two hydroxypropyl groups. The patent also outlines various concentration ranges, impurity limits, and suitability for human administration, emphasizing the stringent quality control measures implemented in the formulation process.

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