Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Cellular products or processes of preparing a cellular...
Patent
1996-03-05
1998-03-10
Foelak, Morton
Synthetic resins or natural rubbers -- part of the class 520 ser
Synthetic resins
Cellular products or processes of preparing a cellular...
21050029, 21050035, 21050042, 521 63, 521 64, C08J 926, C08J 928, B01D 3900
Patent
active
057262128
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a polymer membrane having a high permeability for alkanol, and more particularly to a alkanol permeation polymer membrane used as a barrier membrane controlling the release rate of drugs and permeation enhancers to assist the delivery of drugs across the skin.
2. Description of Related Art
Transdermal drug delivery system is the drug delivery system that delivers drugs and enhancers across the skin into the body at the constant rate. The transdermal drug delivery system has been proven successful for a number of drug such as nitroglycerin to treat angina or congestive heart failure, scopolamine to treat motion sickness, clonidine to reduce blood pressure, nicotine to treat the prohibition phenomenon, or steroid hormones such as estradiol, testosterone, and progesterone.
General structure of the transdermal drug delivery system includes a reservoir for drugs and permeation enhancers, and a control membrane provided at releasing side for controlling the release of the drug and the permeation enhancers.
In the development of the transdermal drug delivery system such as above, the preparation of the control membrane for controlling the permeation rate of drugs and permeation enhancers is very important.
As a control membrane described above, various alkanol permeation polymer membranes such as MPS, porous PVC sheet, Millepore filter, Celgard porous polypropylene, Ultra-microporous cellulose triacetate (J. Gen. Physiol. 38:225, 1954; J. Biomed. Mater. Res., 5:459, 1971), silicon rubber (J. Sug. Res., 4:139, 1964; I. J. Pharm., 77:221-229, 231-237, 1991), ethylene vinylacetate (EVA) copolymer (U.S. Pat. No. 4,379,454, U.S. Pat. No. 4,681,584 and U.S. Pat. No. 4,698,062) have been reported. However, the conventional alkanol permeation membranes described above are not practically used because the amount of the alkanol permeation enhancer across the alkanol membrane is not enough to enhance the permeation of drugs.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a novel alkanol permeation polymer membrane which enables a high ethanol permeation to enhance the transdermal delivery of hormone drugs such as estradiol progesterone, and testosterone.
The present invention provides a process for preparing alkanol permeation polymer membrane comprising the steps of: dissolving biocompatible, non-allergenic polymer capable of being dissolved in polar organic solvent in methylene chloride to prepare a first solution; dissolving cellulose or glycol type polyol compounds in cosolvent composed of alkanol and methylene chloride to prepare a second solution; mixing the first solution with the second solution; and casting the mixed solution on glass with the thickness controlled by the use of a film casting knife (Gardner film knife) and evaporating solvent to obtain a membrane.
The biocompatible, non-allergenic polymer capable of being dissolved in polar organic solvent of the present invention is preferably selected from the group consisting of ethylene/vinylacetate copolymer, ethylene/vinylalcohol copolymer, ethylene/ethylacrylate copolymer, vinylidenechloride/vinylacetate copolymer, polymethacrylate, vinyledenchloride and ethylene/vinyloxyethanol copolymer.
The cellulose or glycol type polyol compound of the present invention is preferably one or the mixture selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose, polyethyleneglycol, glycerin and ethyleneglycol.
The added amount of said cellulose or glycol type polyol compound is preferably 1 to 30 wt % with respect to said biocompatible, non-allergenic polymer capable of being dissolved in polar organic solvent. If the added amount is beyond the above, then the polymer membrane is not formed and cracked.
The alkanol of cosolvent for cellulose or glycol type polyol compound in the present invention is preferably selected from the group consisting of C.sub.2 to C.sub.8 alkanols including ethanol, propanol, butanol, pentanol
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E.M. Renkin; Filtration, Diffusion, and Molecular Sieving Through Porous Cellulose Membranes; J. Gen Physiol. 38; (received for publication May 4, 1954) pp. 225-243.
C.K. Colton, et al; Permeability Studies with Cellulosic Membranes; J. Biomed. Mater. Res. vol. 5 (1971); pp. 459-488.
J. Folkman, et al; The Use of Silicone Rubber as a Carrier for Prolonged Drug Therapy; J. Sug. Res. vol. IV, No. 3 Mar. 1964; pp. 139-142.
S.H. Yuk, et al; One-way Membrane for Transdermal Drug Delivery Systems. I. Membrane Preparation and Characterization; International Journal of Pharmaceutics, 77 (1991); pp. 221-229.
S.H. Yuk, et al; One-way Membrane for Transdermal Drug Delivery Systems. II. Optimization; International Journal of Pharmaceutics 77, (1991) pp. 231-237.
G.M. Zentner, et al; Progestin Permeation Through Polymer Membranes IV: Mechanism of Steroid Permeation and Functional Group Contributions to Diffusion Through Hydrogel Films; Journal of Pharmaceutical Sciences, vol. 68, No. 8 Aug. 1979; pp. 970-975.
Cho Sunhang
Lee Haibang
Yuk Soonhong
Foelak Morton
Korea Research Institute of Chemical Technology
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