Principia Biopharma has been granted a patent for modified release formulations of a BTK inhibitor, Compound I, in solid oral dosage forms. The formulations include specific coatings and polymers for controlled release. GlobalData’s report on Principia Biopharma 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 Principia Biopharma, was a key innovation area identified from patents.

Modified release solid oral dosage form for btk inhibitor

Source: United States Patent and Trademark Office (USPTO). Credit: Principia Biopharma Inc

A recently granted patent (Publication Number: US11872229B2) discloses a modified release solid oral dosage form that includes a core composition containing specific isomers of a compound known as Compound I. The dosage form is designed to release less than 10% of Compound I in less than two hours at a low pH, while releasing at least 80% of the compound within 15 minutes to two hours at a higher pH. The remaining amount of Compound I is released by the end of approximately 7.5 hours at the higher pH level. The core composition may contain between 30 mg to 100 mg of Compound I or its salt, along with various excipients like fillers, disintegrants, and lubricants.

Furthermore, the modified release solid oral dosage form includes sub-coating and enteric coating layers, with the sub-coating layer comprising polyvinyl alcohol and the enteric coating layer containing a copolymer of methacrylic acid and ethyl acrylate. The enteric coating layer also includes a solubilizer and a plasticizer/anti-tacking agent. The patent specifies the weight percentages of the core composition, sub-coating layer, and enteric coating layer in the total weight of the dosage form, along with the specific cellulose derivatives that can be used in the formulation. These detailed claims aim to protect the unique composition and release characteristics of the modified release solid oral dosage form, ensuring its novelty and inventiveness in the pharmaceutical field.

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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