Product quality control method

Patent metadata

Field	Value
Publication number	US-9977846-B2
Application number	US-201214129858-A
Country	US
Kind code	B2
Filing date	Jul 6, 2012
Priority date	Jul 8, 2011
Publication date	May 22, 2018
Grant date	May 22, 2018

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.

First claim

The invention claimed is:

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):

Content
⁢

⁢

(
%
)

⁢

⁢
of
⁢

⁢
an
⁢

⁢
active
⁢

⁢
ingredient

=

Xa
_

·

Wa
_

100

(
a
)

wherein
Xa : Active ingredient concentration in granules for tableting or encapsulation (vs. theoretical concentration %), and
Wa : Weight of uncoated tablet or capsule (vs. theoretical weight %).

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):

Acceptance
⁢

⁢
value
⁢

⁢

(
%
)

⁢

⁢
for
⁢

⁢
uniformity
⁢

⁢
of
⁢

⁢
dosage
⁢

⁢
units

=



M
-

Xa
_

·

Wa
_

100



+

k
⁢

s
w
2

·

(

Xa
_

Assignees

• Nakagawa Hiroshi
• Kamada Makoto
• Maeda Jin
• Daiichi Sankyo Co Ltd

Inventors

• Nakagawa Hiroshi
• Kamada Makoto
• Maeda Jin

Classifications

• A61J3/005

  Coating of tablets or the like (coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006) · CPC title

• G01N33/15

  Medicinal preparations {; Physical properties thereof, e.g. dissolubility} · CPC title

• G05B15/02

  electric · CPC title

• A61K31/444 Primary

  containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone · CPC title

• A61K9/2853

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide) · CPC title