Pharmaceutical dosage form

TH123142BActive Publication Date: 2026-07-23RECORDATI AG
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Patent Information

Application Number
TH1701000059
Authority / Receiving Office
TH · TH
Patent Type
Patents
Current Assignee / Owner
Priority Date
2015-07-06
Filing Date
2015-07-06
Publication Date
2026-07-23
Estimated Expiration
2035-07-05

AI Technical Summary

Technical Problem

The development of pharmaceutical dosage forms for the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile is hindered by its strong tendency to aggregation, poor pharmaceutical processability, low bulk density, chemical instabilities, and incompatibilities with other ingredients, particularly in its phosphate salt form, making it difficult to design stable and swallowable oral dosage forms.

Method used

Incorporating at least 30% by weight of microcrystalline cellulose (MCC) in the pharmaceutical dosage form, along with colloidal silicon dioxide as a glidant, to create a pharmaceutically processible blend that addresses aggregation, flowability, and stability issues, and using a specific blending process to prepare the dosage form.

Benefits of technology

The use of MCC and colloidal silicon dioxide transforms the cohesive drug substance into a well-processible blend, improving flow, stability, and tablet hardness, while preventing capping issues and chemical degradation, enabling the production of stable and commercially viable oral dosage forms.

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Abstract

Updated 03 / 04 / 2017 This invention relates to a pharmaceutical dosage form for action. Contains the drug compound 4-[(5R)-6,7-dihydro-5H-pyrolo[1,2-c]imidasol-5-il]-3- Fluorobenzonitrile or any pharmaceutically acceptable salts of these and their processes. For the production of such solid pharmaceutical dosage forms. ------------------- This invention relates to a pharmaceutical dosage form for the action of which... Contains the drug compound 4-[(5R)-6,7-dihydro-5H-pyrolo[1,2-c]imidasol-5-il]-3- Fluorobenzonitrile or any pharmaceutically acceptable salts of these and their processes. For the production of such solid pharmaceutical dosage forms;
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