US 10,625,233 B2Granted

Testing pharmaceuticals and related substances

AssigneeTannas Co.

InventorsJonathan C. Evans, Derrick D. Hilliker, Theodore W. Selby

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Abstract

An active pharmaceutical ingredients (API) or related substance (RS) can be tested for stability by placing the API or RS in an instrument containing a pressure-controllable atmosphere, controlling the pressure of the atmosphere in the instrument for a predetermined time, and evaluating the API or RS for stability. Testing can be carried out also at predetermined temperature(s) and/or under the influence of gaseous trigger(s) and so forth. For instance, an API sample can be placed in a bomb test instrument/reactor, oxygen as a gaseous trigger can be introduced to contact the API sample under constant and/or ramped temperature(s) and elevated pressure(s) for predetermined time(s), and the API sample can be evaluated for stability. An insert carousel may hold a sample of API(s) and/or RS(s) and/or aliquot(s) of sample(s) of API(s) and/or RS(s) for insertion into the bomb test instrument/reactor.

Claims12

Dependent claims

A method of testing a sample of at least one API and/or at least one RS for stability comprising placing said sample in an instrument containing a pressure-controllable atmosphere, controlling the pressure of the atmosphere in the instrument for a predetermined time, and evaluating the at least one API and/or the at least one RS of said sample for stability, wherein the testing is carried out:

under at least one predetermined temperature;
and
under the influence of at least one gaseous trigger, which is introduced to contact
the sample under constant and/or ramped temperature(s) and elevated
pressure(s) for one or more predetermined times,
wherein the instrument is a bomb test instrument/reactor that is a rotatable bomb device, which has a housing with a hollow interior;
a rotatable component located in the hollow interior, which is or includes an inner container that is rotated during at least part of the testing;
and support for the rotatable component in the hollow interior.

5 more elements

Dependencies are inferred from the claim text.

Facts

Application: 15/932,658Filed 3 Apr 2018 · us provisional application
Priority: 4 Apr 2017
Published: US 2018/0326385 A115 Nov 2018
Granted: 21 Apr 2020
Term ends: Not estimatedThe source records don’t support an estimate.

Classification18 codes

B01J 19/0013
Controlling or regulating processes: controlling the temperature of the process
B01J 19/02
Chemical, physical or physico-chemical processes in general; Their relevant apparatus: apparatus characterised by being constructed of material…
B01L 9/06
Supporting devices; Holding devices: test-tube stands; Test-tube holders
G01N 25/20
Investigating or analyzing materials by the use of thermal means: by investigating the development of heat, i.e. calorimetry, e.g. by measuring…