Aqueous oral pharmaceutical suspension compositions
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Publication Number
US-11382922-B2
Publication Date
2022-07-12
Expiration Date
Abstract
Provided is an aqueous oral pharmaceutical suspension composition comprising vamorolone Form I. Also provided are methods for its preparation and its use.
Core Innovation
The invention provides an aqueous oral pharmaceutical suspension composition comprising vamorolone Form I, at least one suspending agent, and at least one suspension vehicle. The suspension is characterized to maintain the solid form and quality of vamorolone Form I within the suspension.
The document characterizes vamorolone Form I using solid-form analytical criteria including X-ray powder diffraction and thermal/gravimetric behavior. The X-ray powder diffraction pattern is described with radiation Cu Kα and peaks at about 11.9, about 13.7, about 16.1, and about 18.3, and thermogravimetric analysis is described with less than about 0.5% weight loss below about 175°C.
Differential scanning calorimetry is described with an exothermic event onset at 180.7°C and a melting event with onset and peak temperatures of 231.0°C and 234.7°C, respectively. The invention further addresses chemical purity and impurity limits for vamorolone Form I in the pharmaceutical suspension, particle size using a d90 threshold of less than about 50 μm, and stability described using assay and impurity trends under specified storage conditions.
Claims Coverage
The partial content includes three independent claims. Across these claims, the inventive coverage focuses on an aqueous oral suspension composition containing vamorolone Form I with suspending agent and suspension vehicle, and crystalline forms of vamorolone defined by solid-state characterization, purity, and particle size limitations.
Aqueous oral suspension with vamorolone Form I
An aqueous oral pharmaceutical suspension composition comprising vamorolone Form I, at least one suspending agent, and at least one suspension vehicle.
Crystalline form of vamorolone defined by solid-state characterization and purity
A crystalline form of vamorolone characterized by X-ray powder diffraction peaks at about 11.9, about 13.7, about 16.1, and about 18.3 with radiation Cu Kα, thermogravimetric analysis showing less than about 0.5% weight loss below about 175°C, differential scanning calorimetry with an exothermic event onset at 180.7°C and a melting event with onset and peak temperatures of 231.0°C and 234.7°C, and chemical purity of at least about 95% by high throughput liquid chromatography.
Crystalline form defined by solid-state characterization with particle size limitation
A crystalline form of vamorolone characterized by the same solid-state characterization features and a particle size such that d90 is less than about 50 μm.
Overall, the claim coverage ties the invention to an aqueous oral pharmaceutical suspension composition containing vamorolone Form I together with a suspending agent and a suspension vehicle, and to crystalline forms of vamorolone defined by specific X-ray powder diffraction, thermogravimetric analysis, differential scanning calorimetry, chemical purity, and particle size features.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating and/or reducing symptoms of muscular dystrophy via administration of the aqueous oral pharmaceutical suspension.
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