Product quality control method

• US 9,977,846 B2
• Filed: 07/06/2012
• Issued: 05/22/2018
• Est. Priority Date: 07/08/2011
• Status: Active Grant

• Current Assignee: Daiichi Sankyo Company Limited
• Original Assignee: Daiichi Sankyo Company Limited
• Inventors: Nakagawa, Hiroshi, Kamada, Makoto, Maeda, Jin
• Primary Examiner(s): Alhija, Saif A
• Application Number:
  US14/129,858
• Publication Number:
  US 20140136157A1
• Time in Patent Office: 2,146 Days
• Field of Search: 703 1
• CPC Class Codes: A61J 3/005 Coating of tablets or the like coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006
• CPC Class Codes: A61K 31/444 containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
• CPC Class Codes: A61K 9/2853 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility drug screening with animal cells G01N33/5008
• CPC Class Codes: G05B 15/02 electric
• CPC Class Codes: G05B 17/02 electric
• CPC Class Codes: G06F 30/20 Design optimisation, verification or simulation optimisation, verification or simulation of circuit designs G06F30/30

Abstract

A real-time release testing capable of constantly ensuring quality, a method for quality testing of a product using real-time release testing, a method for quality testing of an in-process product and/or an end product by real-time release testing, comprising the step of assessing the quality from design space established with only material attributes as inputs, and a manufacturing parameter-independent method for quality testing of a product using real-time release testing.

Claims

1. A method for real-time release testing of a product in a manufacturing process for a quality attribute, comprising:

(a) establishing a design space for the quality attribute of the product using only material attributes as inputs, wherein establishing the design space comprises the steps of;

(1) extracting one or more first material attributes of one or more materials used in the manufacturing process and one or more manufacturing process parameters used in the manufacturing process that influence the quality attribute of the product;

(2) converting the one or more manufacturing process parameters to one or more second material attributes, wherein the one or more second material attributes are directly influenced by the one or more manufacturing process parameters;

(3) calculating a correlation between the one or more first material attributes and the one or more second material attributes and the quality attribute; and

(4) preparing the design space using the correlation and setting a value of a calculated quality attribute to within a range of acceptable values;

(b) performing the manufacturing process according to the design space;

(c) determining the one or more first material attributes and the one or more second material attributes in the manufacturing process; and

(d) assessing the quality attribute of the product from the determined one or more first material attributes and one or more second material attributes and the design space to provide a quality attribute test result.

2. The method according to claim 1, wherein the method establishes design space for a quality attribute of a drug product.

3. The method according to claim 2, wherein the drug product is a tablet or a capsule.

4. The method according to claim 3, wherein the quality attribute is the content of an active ingredient in the tablet or the capsule.

5. The method according to claim 4, wherein the material attributes are the active ingredient concentration in granules for tableting or encapsulation and the weight of the uncoated tablet or the capsule.

6. The method according to claim 5, wherein the method establishes design space for the content of an active ingredient according to the following expression (a):

7. The method according to claim 3, wherein the quality attribute is the uniformity of dosage units of the tablet or the capsule.

8. The method according to claim 7, wherein the material attributes are the blend uniformity, the active ingredient concentration in granules for tableting or encapsulation, the weight of the uncoated tablet or the capsule, and the weight variation of the uncoated tablet or the capsule.

9. The method according to claim 8, wherein the method establishes design space for the uniformity of dosage units according to the following mathematical expression (e):

10. The method according to claim 1, wherein the method is used in real-time release testing of an end product.

11. The method according to claim 1, wherein the design space of an end product is established using the design space of two or more in-process products.

12. The method of claim 1, further comprising performing experiments to confirm that the one or more first material attributes of one or more materials used in the manufacturing process and the one or more manufacturing process parameters used in the manufacturing process influence the quality attribute.

13. The method of claim 1, wherein determining the one or more first material attributes includes measuring a physical property of the one or more materials used in the manufacturing process;

and wherein determining the one or more second material attributes of the product includes measuring a physical property of the product.