US 12,306,082 B2
Apparatus and method for monitoring and recording disintegration times for pharmaceutical products
Grace Chen, Lansdale, PA (US); Joanna C. Everitt, Upper Black Eddy, PA (US); Sydney Floryanzia, Apex, NC (US); Janakiraman Gopinath, Morris Plains, NJ (US); and Prashant I. Shah, Morganville, NJ (US)
Assigned to Merck Sharp & Dohme LLC, Rahway, NJ (US)
Appl. No. 17/762,253
Filed by Merck Sharp & Dohme LLC, Rahway, NJ (US)
PCT Filed Sep. 29, 2020, PCT No. PCT/US2020/053177
§ 371(c)(1), (2) Date Mar. 21, 2022,
PCT Pub. No. WO2021/067207, PCT Pub. Date Apr. 8, 2021.
Claims priority of provisional application 62/909,351, filed on Oct. 2, 2019.
Prior Publication US 2022/0334040 A1, Oct. 20, 2022
Int. Cl. G01N 13/00 (2006.01); G01N 33/15 (2006.01); G01N 35/00 (2006.01)
CPC G01N 13/00 (2013.01) [G01N 33/15 (2013.01); G01N 35/00 (2013.01); G01N 2013/006 (2013.01); G01N 2035/00198 (2013.01)] 20 Claims
OG exemplary drawing
 
1. An apparatus for determining whether a dosage unit of a drug disintegrates in an immersion fluid of a disintegration tester within a prescribed time limit, the disintegration tester including a reciprocating arm that repetitively moves the dosage unit up and down in the immersion fluid in accordance with a prescribed range and frequency of motion, the apparatus comprising:
(a) a computer system comprising a microprocessor, an output device, a system clock, a primary memory, and a secondary memory, the secondary memory including a first frame buffer and a duration record;
(b) a motion sensor;
(c) a first capture device;
(d) a fastener for attaching the first capture device to the reciprocating arm of the disintegration tester;
(e) a first data communications interface that carries motion data from the motion sensor to the computer system;
(f) a second data communications interface that carries image data from the first capture device to the computer system;
(g) an application program, in the primary memory of the computer system, comprising program instructions that, when executed by the microprocessor, will cause the microprocessor to
(i) receive motion data from the motion sensor over the first data communications interface,
(ii) determine, based on the motion data, that the reciprocating arm is moving in accordance with the prescribed range and frequency of motion,
(iii) after determining that the reciprocating arm is moving in accordance with the prescribed range and frequency of motion, retrieve a current time from the system clock and record the current time in the secondary memory as a start time for disintegration of the dosage unit,
(iv) receive over the second data communications interface a first stream of frames captured over time by the first capture device, each frame in the first stream of frames comprising image data for an image of the dosage unit in the immersion fluid,
(v) store the first stream of frames in the first frame buffer in the secondary memory,
(vi) select a frame from the first stream of frames,
(vii) retrieve from the first frame buffer the image data for the selected frame,
(viii) calculate a background differential for the image data for the selected frame,
(ix) compare the background differential to a specified target background differential,
(x) if the background differential is less than or equal to the specified target background differential, calculate a first disintegration time by subtracting the start time from the current time and set a duration value for the duration record of the secondary memory equal to the first disintegration time,
(xi) if the background differential is greater than the specified target background differential, select a new frame from the first stream of frames and repeat steps (g)(vii) through (g)(x) of this claim until the background differential is less than or equal to the specified target background differential, and
(xii) transmit a success indicator to the output device if the duration value is less than or equal to the prescribed time limit.