US20050025809A1
Expired / Lapsed
US
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Poly-4-hydroxybutyrate matrices for sustained drug delivery
Assignee: Tepha Inc
•
Filing: 2004-07-08
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Granted: —
•
Expires: 2024-07-08
Abstract
Abstract Biodegradable controlled release systems providing prolonged controlled release of drugs, and methods for the manufacture thereof are disclosed. The systems are formed from a biocompatible, biodegradable polymer, in particular poly-4-hydroxybutyrate (PHA4400) or copolymers thereof. Copolymers of 4-hydroxybutyrate include but are not limited to poly-3-hydroxybutyrate-co-4-hydroxybutyrate (PHA3444), and poly-4-hydoxybutyrate-co-glycolate (PHA4422). Drugs are generally incorporated into the polymer using a method that yields a uniform dispersion. The type of drug and the quantity are selected based on the known pharmaceutical properties of these compounds. The systems may be administered for example by implantation, injection, topical administration, or oral ingestion. They may also be used in combination with a medical device, for example, a stent. A major advantage of the drug delivery system is that it does not need to be removed after use since it is slowly degraded and cleared by the patient's body. The device has desirable physical properties, including strength, modulus and elongation.
Inventors
- 👤 Vasif Hasirci
- 👤 Dilek Keskin
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:51
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/14; A61K9/16; A61K9/1605; A61K9/1629; A61K9/1641; A61K9/0012; A61K9/0019; A61K9/0024; A61K9/20; A61K9/2004; A61K9/2022; A61K9/2031; A61P; A61P31/00
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
36 words
1 . A biodegradable controlled release drug delivery system comprising drug uniformly distributed in poly-4-hydroxybutyrate wherein the drug is incorporated into the polymer at a percent loading of up to 50% by weight of the device.
Claim 2
Dependent Claim
36 words
1 . A biodegradable controlled release drug delivery system comprising drug uniformly distributed in poly-4-hydroxybutyrate wherein the drug is incorporated into the polymer at a percent loading of up to 50% by weight of the device.
Claim 3
Dependent Claim
23 words
2 . The drug delivery system of claim 1 wherein less than 60% of the drug is released in vitro after 10 days.
Claim 4
Dependent Claim
23 words
3 . The drug delivery system of claim 1 wherein less than 35% of the drug is released in vitro after 10 days.
Claim 5
Dependent Claim
31 words
4 . The drug delivery system of claim 1 wherein the drug is selected from the group consisting of proteins, peptides, polysaccharides, nucleic acid molecules, and synthetic or natural organic compounds.
Claim 6
Dependent Claim
15 words
5 . The drug delivery system of claim 4 wherein the drug is an antibiotic.
Claim 7
Dependent Claim
18 words
6 . The drug delivery system of claim 1 wherein the drug is coated onto a medical device.
Claim 8
Dependent Claim
20 words
7 . The drug delivery system of claim 1 wherein the device is formed of the poly-4-hydroxybutyrate or copolymer thereof.
Claim 9
Dependent Claim
24 words
8 . The drug delivery system of claim 1 wherein the poly-4-hydroxybutyrate or a copolymer thereof is formed of or coated onto a stent.
Claim 10
Dependent Claim
25 words
9 . The drug delivery system of claim 1 in a form selected from the group consisting of granules, sheets, films, particles, and molded forms.
Claim 11
Dependent Claim
19 words
10 . The drug delivery system of claim 1 wherein the copolymer is a copolymer of 3-hydroxybutyrate and 4-hydroxybutyrate.
Claim 12
Dependent Claim
19 words
11 . The drug delivery system of claim 1 wherein the copolymer is a copolymer of 4-hydroxybutyrate and glycolate.
Claim 13
Dependent Claim
18 words
12 . The drug delivery system of claim 1 wherein the device exhibits linear release of the drug.
Claim 14
Dependent Claim
18 words
13 . The drug delivery system of claim 1 wherein the device exhibits zero-order release of the drug.
Claim 15
Dependent Claim
19 words
14 . The drug delivery system of claim 1 wherein the device does not release a burst of drug.
Claim 16
Dependent Claim
19 words
15 . The drug delivery system of claim 1 wherein the device releases drug for at least 21 days
Claim 17
Dependent Claim
19 words
16 . The drug delivery system of claim 1 wherein the device releases drug for at least one month.
Claim 18
Dependent Claim
19 words
17 . The drug delivery system of claim 1 wherein the device releases drug for at least three months.
Claim 19
Dependent Claim
19 words
18 . The drug delivery system of claim 1 wherein the device releases drug for at least six months.
Claim 20
Dependent Claim
50 words
19 . A method of delivering a drug comprising administering to an individual in need thereof a biodegradable controlled release drug delivery system comprising drug uniformly distributed in poly-4-hydroxybutyrate wherein the drug is incorporated into the polymer at a percent loading of up to 50% by weight of the device.
Claim 21
Dependent Claim
50 words
19 . A method of delivering a drug comprising administering to an individual in need thereof a biodegradable controlled release drug delivery system comprising drug uniformly distributed in poly-4-hydroxybutyrate wherein the drug is incorporated into the polymer at a percent loading of up to 50% by weight of the device.
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