Kaken Pharmaceutical has filed a patent for a pharmaceutical formulation that can be applied externally to the human body. The formulation contains sofpironium bromide, a water-soluble polymer, and ethanol. It has a pH of 5.2 or lower and is a uniformly dispersed, non-aqueous formulation with a water content of 5% or lower. The patent claims that the pH remains stable for at least 6 months after preparation. GlobalData’s report on Kaken Pharmaceutical gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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Pharmaceutical formulation for external application with low viscosity and ph
A recently filed patent (Publication Number: US20230149349A1) describes a pharmaceutical formulation designed for external application to the human body. The formulation includes sofpironium bromide, one or more water-soluble polymers, and ethanol. It is a non-aqueous formulation with a pH of 5.2 or lower and a water content of 5% or lower. The pH is measured within 6 months of preparation by immersing a pH electrode in the formulation for 5 minutes. The content of sofpironium bromide in the formulation is between 1% and 20% based on the total weight.
The formulation also contains a water-soluble polymer or polymers, which can be hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, a carboxyvinyl polymer, polyvinyl alcohol, a polyvinyl copolymer, polyvinylpyrrolidone, or copovidone. The content of the water-soluble polymer or polymers is between 0.01% and 5.0% based on the total weight of the formulation.
Ethanol makes up 50% to 99% of the formulation by weight. The formulation may also contain a pH adjuster, such as tartaric acid, acetic acid, or citric acid, or a salt thereof. The amount of the pH adjuster is between 0.015% and 5% based on the total weight of the formulation.
Additionally, the formulation may include a non-volatile oil, such as a non-volatile ester, ether, silicone, or alcohol. The non-volatile oil can be selected from a wide range of options, including ethyl myristate, isopropyl myristate, diisopropyl adipate, and various other fatty acid esters. The content of the non-volatile oil is between 0.5% and 10% based on the total weight of the formulation.
The formulation has a viscosity of 10 to 2000 mPa·s at 25°C and can be used for medical care, therapeutic treatment, or prevention of various diseases, including hyperhidrosis, overactive bladder, chronic obstructive pulmonary disease, cardiac disease, salivation, ocular disease, and bronchial asthma.
Overall, this patent describes a pharmaceutical formulation for external application to the human body, which includes specific ingredients and meets certain criteria for pH, water content, and viscosity. It has potential applications in the treatment of various medical conditions.
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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
