Intravaginal matrix drug delivery devices
First Claim
1. A process for increasing the magnitude of the amount of at least one therapeutic agent released from an intravaginal matrix drug delivery device within the first 24 hours of use of an exponential (first order) release decay, the process consisting essentially of preparing an intravaginal matrix drug delivery device by the steps of:
- combining 5% to less than 30% (w/w) of at least one therapeutic agent with at least one biocompatible silicone elastomeric polymer, to form a mix suitable for forming a shape-retaining polymer matrix, in which the at least one therapeutic agent has a solubility in silicone oil at 25°
C. of less than 0.1 mg/ml;
curing said mix at 50-100°
C. for 1-10 minutes or at 15-25°
C. for 1-24 hours to form the shape-retaining polymer matrix; and
maturing said shape-retaining polymer matrix under temperature and time conditions sufficient to form the intravaginal drug delivery device to produce a device having altered release rate characteristics, in which said maturing step is carried out at 40-100°
C. for 2-72 hours;
wherein the magnitude of the amount of said at least one therapeutic agent released from said intravaginal matrix drug delivery device within the first 24 hours of use of an exponential (first order) release decay is increased compared to said shape-retaining polymer matrix that did not undergo the step of maturing.
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Abstract
The present invention relates to a process for the preparation of an intravaginal matrix drug delivery device. The process comprises the steps of combining at least one therapeutic agent in a therapeutically effective amount with at least one biocompatible elastomeric polymer to form a mix; curing said mix in a mold having a shape of said intravaginal drug delivery device, to form a polymer matrix; and maturing said polymer matrix to form the intravaginal drug delivery device.
The maturing step alters the release rate characteristics of a device prepared in accordance with the process of the invention.
16 Citations
9 Claims
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1. A process for increasing the magnitude of the amount of at least one therapeutic agent released from an intravaginal matrix drug delivery device within the first 24 hours of use of an exponential (first order) release decay, the process consisting essentially of preparing an intravaginal matrix drug delivery device by the steps of:
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combining 5% to less than 30% (w/w) of at least one therapeutic agent with at least one biocompatible silicone elastomeric polymer, to form a mix suitable for forming a shape-retaining polymer matrix, in which the at least one therapeutic agent has a solubility in silicone oil at 25°
C. of less than 0.1 mg/ml;curing said mix at 50-100°
C. for 1-10 minutes or at 15-25°
C. for 1-24 hours to form the shape-retaining polymer matrix; andmaturing said shape-retaining polymer matrix under temperature and time conditions sufficient to form the intravaginal drug delivery device to produce a device having altered release rate characteristics, in which said maturing step is carried out at 40-100°
C. for 2-72 hours;
wherein the magnitude of the amount of said at least one therapeutic agent released from said intravaginal matrix drug delivery device within the first 24 hours of use of an exponential (first order) release decay is increased compared to said shape-retaining polymer matrix that did not undergo the step of maturing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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Specification