# US 7,611,630 B2 · Method and device for evaluation of pharmaceutical compositions

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- Number: US 7,611,630 B2
- Document ID: US7611630B2
- Status: Granted
- Kind: B2
- Application number: 10/590,989
- Filed: 2005-03-18
- Published: 2007-09-06
- Granted: 2009-11-03
- Earliest claimed: 2004-03-30
- Assignees: Bend Research, Inc.
- Inventors: Walter Christian Babcock; Dwayne Thomas Friesen; Scott Baldwin McCray
- Web page: https://patentgrep.com/patent/US7611630B2

## CPC

- B01D 61/147: {Microfiltration}
- B01D 61/28: Apparatus therefor
- B01D 67/009: {with wave-energy, particle-radiation or plasma}
- B01L 3/50255: {Multi-well filtration}
- B01L 3/5085: {for multiple samples, e.g. microtitration plates}
- G01N 33/15: Medicinal preparations {; Physical properties thereof, e.g. dissolubility}
- B01D 2325/36: Hydrophilic membranes
- B01L 2300/0829: Multi-well plates; Microtitration plates
- B01L 2300/161: Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
- B01L 2400/0472: Diffusion
- G01N 2013/006: {Dissolution of tablets or the like}
- Y10S 436/809: Multifield plates or multicontainer arrays
- Y10T 436/255: including use of a solid sorbent, semipermeable membrane, or liquid extraction
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A membrane-permeation test for evaluating pharmaceutical compositions is described. The method comprises the following steps: (1) providing a microporous membrane having a plurality of pores, the membrane having a feed side and a permeate side, wherein the feed side of the membrane is in fluid communication with the feed solution, and wherein the permeate side of the membrane is in fluid communication with a permeate solution; (2) administering a pharmaceutical composition to an aqueous solution to form a feed solution; and (3) measuring the concentration of drug in the permeate solution; wherein the feed side of the membrane is hydrophilic, and/or wherein the permeate solution comprises an organic fluid.

## Claims

### Claim 1

A method for evaluating a pharmaceutical composition comprising a drug, said method comprising:
(1) providing a microporous membrane having a plurality of pores, said membrane being made from a hydrophobic material, and said membrane having a hydrophilic feed side and a permeate side, wherein said feed side of said membrane is in fluid communication with a feed solution, and wherein said permeate side of said membrane is in fluid communication with a permeate solution;
(2) administering said pharmaceutical composition to an aqueous solution to form said feed solution; and
(3) measuring the concentration of said drug in said permeate solution;
wherein said permeate side of said microporous membrane has a contact angle for a drop of water of greater than about 90° and said feed side of said microporous membrane has a contact angle for a drop of water of less than about 70°, and wherein said permeate solution comprises an organic fluid that is substantially immiscible with water.

### Claim 2 (depends on 1)

The method of claim 1 wherein said pores have a nominal size of about 0.02 μm to about 0.5 μm.

### Claim 3 (depends on 1)

The method of claim 1 wherein said drug has a partition coefficient between said organic fluid and water of at least 5.

### Claim 4 (depends on 1)

The method of claim 1 wherein said organic fluid is selected from the group consisting of alkanes, alkenes, alcohols, ethers, ketones, aromatics, alkyl halides, and mixtures thereof.

### Claim 5 (depends on 1)

The method of claim 1 wherein said organic fluid comprises a mixture of at least one alkane having from 8 to 12 carbon atoms and at least one alcohol having from 8 to 12 carbon atoms.

### Claim 6 (depends on 1)

The method of claim 1 wherein said aqueous solution is selected from the group consisting of phosphate buffered saline, simulated intestinal buffer without enzymes, a model fasted duodenal solution, and a solution to model the fed state.

### Claim 7 (depends on 1)

The method of claim 1 wherein said drug is a low-solubility drug.