Sovaprevir tablets

A technology of tablets, inhibitors, applied in the field of Sovaprevir tablets

Inactive Publication Date: 2016-02-24
ACHILLION PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The manner in which these ingredients are combined and processed into final solid dosage forms

Method used

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Examples

Experimental program
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Effect test

preparation example Construction

[0045] The manufacturing process of Sovaprevir tablets was optimized by evaluating the blend and tablet physical properties including: bulk and tap density measurements of the blend, flow analysis, sieve analysis, and uniformity; Tablet weight, thickness, hardness, friability, potency, disintegration, dissolution and content consistency testing.

[0046] The present disclosure provides methods for preparing Sovaprevir tablets. In one embodiment, the method includes the following steps.

[0047] First, half of the hydroxypropyl methylcellulose is fed into a blender, such as a V-blender or a box blender, then Sovaprevir is added followed by the remaining half of the hydroxypropyl methylcellulose , and then blend the materials.

[0048] The magnesium stearate can be sieved, such as through a 20 mesh screen, to break up any agglomerates. The sieved magnesium stearate was added to the blender containing the Sovaprevir / crystal growth inhibitor blend and blended for a few minutes....

Embodiment 1

[0061] Example 1. Sovaprevir Tablet Composition

[0062] The three dosage strengths of Sovaprevir tablet cores are for example 100 mg, 200 mg and 250 mg. The 100 mg tablet core size is a standard round concave of 7 / 16 inch and has a theoretical weight of 400 mg. The 200 mg tablet core size is 9 / 16 inch standard circular concave and has a theoretical weight of 800 mg. A 200 mg modified oval tablet core, 0.34 inches by 0.70 inches, is also included. The 250 mg tablet cores are 0.3652 inch x 0.7480 inch modified oval tablet cores with a theoretical weight of 1000 mg. The 300 mg tablet cores were modified oval tablet cores with dimensions 0.3990 inches by 0.7550 inches. All dimensions refer to tooling sizes, actual dimensions of finished tablet cores may vary slightly. All tablet cores were a mottled off-white to yellow appearance. The formulations for the 100mg, 200mg and 250mg tablets are the same. 100, 200 and 250 mg strength tablets were prepared using a common blend by ...

Embodiment 2

[0065] Example 2: Alternative Tablet Formulation

[0066] Another example of tablet formulation is provided in Table 2. The formulations are shown for 100 mg, 200 mg and 250 mg tablets.

[0067]

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PUM

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Abstract

The disclosure includes tablet cores comprising Sovaprevir and a crystal growth inhibitor selected from hydroxypropyl methyl cellulose (HPMC), HPC (hydroxypropyl cellulose), hypromellose acetate succinate (HPMCAS), polyvinyl pyrrolidone (PVP), copovidone (PVP-VA), a copolymer of methacrylic acid and ethyl acrylate, or any combination of the foregoing, wherein ratio of Sovaprevir to crystal growth inhibitor is from about 40:60 (w/w) to about 60:40 (w/w). The disclosure further includes film coated tables. The disclosure also includes methods of treating HCV with the tablets described herein.

Description

[0001] References to related applications [0002] This application claims priority to US Provisional Application No. 61 / 790,645, filed March 15, 2013, which is hereby incorporated by reference in its entirety. technical field [0003] Sovaprevir (ACH-0141625) tablets and tablet cores are provided by the present disclosure. Background technique [0004] Sovaprevir is a hepatitis C virus NS3 protease inhibitor that is effective for the treatment of HCV infection in humans. [0005] [0006] Sovaprevir has challenging physical and chemical properties associated with the manufacture of solid dosage forms. Sovaprevir is substantially soluble in its amorphous form, but has at least 6 crystal polymorphs that alter pharmacokinetics and reduce solubility compared to the amorphous form. Sovaprevir has a tendency to form a crystalline form on storage under various conditions. Crystalline forms of Sovaprevir exhibit differences in physical and chemical properties relative to the ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/00A61K31/12
CPCA61K31/4709A61K9/2054A61P31/18A61P43/00A61K9/28A61K38/05A61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2059
Inventor 珍妮弗·辛-钟·初高塔姆·沙阿阿维纳什·帕德克
Owner ACHILLION PHARMA INC
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