IP Library Patent Application 13964986
Patent Application
App. No. 13/964,986

FORMULATION SCREENING METHODS, APPARATUSES FOR PERFORMING SUCH METHODS AND FORMULATIONS FORMED BY SUCH METHODS

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Patent No.
US None
App. No.
13/964,986
Abstract

A method of screening for candidate compound-excipient combinations comprises dosing a compound into each receptacle of a collection of receptacles, dosing a first set of excipients and a second set of excipients into the receptacles wherein the dosing creates varying combinations of solutions of a first and second excipients within the receptacles, analyzing each receptacle for the presence of a precipitate, and classifying the receptacles based on the presence of a precipitate.

Claims (33)

1 . A method of screening for candidate compound-excipient combinations comprising:

dosing a compound into each receptacle of a collection of receptacles;

dosing a first set of excipients and a second set of excipients into said receptacles wherein said dosing creates multiple combinations of solutions of the first excipient set and the second excipient set within said receptacles;

analyzing each receptacle for the presence of a precipitate; and

classifying the receptacles based on the presence of a precipitate.

2 . The method of claim 1 wherein said compound is selected from the group consisting of an active pharmaceutical ingredient, a nutraceutical, or an agricultural active substance.

3 . The method of claim 1 wherein said receptacle is a well plate, a vial, or a test tube.

4 . The method of claim 3 wherein said receptacle is a well plate.

5 . The method of claim 1 wherein said compound is dosed as a solid.

6 . The method of claim 1 wherein said compound is dosed in an organic solvent.

7 . The method of claim 6 wherein said compound and organic solvent form a solution.

8 . The method of claim 1 wherein said receptacles are classified as either having precipitate or not having precipitate.

9 . The method of claim 1 wherein said receptacles are classified based on the relative amount of precipitate present.

10 . The method of claim 6 further comprising the step of removing the organic solvent prior to dosing with the first and second excipient sets.

11 . The method of claim 1 wherein at least one set of excipients includes a set of polymers.

12 . The method of claim 1 wherein at least one set of excipients includes a set of surfactants.

13 . The method of claim 1 wherein at least one set of excipients includes a set of inclusion compounds.

14 . The method of claim 1 wherein the concentration of said first and second excipient sets are in ratios relative to their amounts dosed in the ratios of high/high, high/low, low/high and low/low combinations of said first excipient/second excipient sets wherein the high concentration and the low concentrations are fixed for a set of receptacles.

15 . The method of claim 1 wherein precipitation is analyzed in said receptacles using light obscuration or visual observation.

16 . The method of claim 1 wherein precipitation is analyzed in said receptacles using optical microscopy.

17 . The method of claim 10 wherein said solvent is removed by evaporation.

18 . The method of claim 1 wherein said first and second excipient sets are dosed in an aqueous solution.

19 . The method of claim 18 wherein said first and second excipient sets are dosed in an aqueous ethanol solution.

20 . The method of claim 1 wherein said compound is supersaturated after dosing with the excipients.

21 . The method of claim 20 wherein supersaturation is obtained by increasing and then decreasing the temperature of said receptacle.

22 . The method of claim 1 wherein said receptacle is shaken after dosing.

23 . The method of claim 1 wherein said receptacle is centrifuged after dosing.

24 . The method of claim 1 wherein said receptacle is sonicated after dosing.

25 . The method of claim 1 further comprising performing a concentration gradient analysis comprising:

dosing said compound into a second set of receptacles wherein said compound is dosed from a minimum to a maximum amount of compound;

dosing into each set of receptacles a first and second excipient set selected from the ratios identified in claim 14 ;

analyzing each receptacle for the presence of a precipitate;

classifying the receptacles based on the presence of a precipitate to identify a solubility limit of the composition in the receptacle.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Aug 31, 2017
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: ALBANY MOLECULAR RESEARCH, INC.; ALO ACQUISITION LLC; AMRI BURLINGTON, INC.; AMRI RENSSELAER, INC.; CEDARBURG PHARMACEUTICALS, INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC; AMRI SSCI, LLC; EUTICALS INC.
Reel/Frame 043742/0085 →
SECURITY INTEREST Recorded Aug 5, 2015
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI SSCI, LLC
To: BARCLAYS BANK PLC, AS THE COLLATERAL AGENT
Reel/Frame 036257/0914 →
SECURITY INTEREST Recorded May 26, 2015
From: AMRI SSCI, LLC
To: BARCLAYS BANK PLC, AS THE COLLATERAL AGENT
Reel/Frame 035710/0880 →
CHANGE OF NAME Recorded Apr 23, 2015
From: AMRI AMERICIUM, LLC
To: AMRI SSCI, LLC
Reel/Frame 035487/0184 →
ASSIGNMENT EFFECTIVE 13 FEB 2015 Recorded Apr 23, 2015
From: APTUIT (WEST LAFAYETTE), LLC
To: AMRI AMERICIUM, LLC
Reel/Frame 035492/0830 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 18, 2014
From: SELBO, JON
To: APTUIT (WEST LAFAYETTE), LLC
Reel/Frame 034546/0478 →