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BR-112020000320-B1 - BIOERODIBLE DRUG DELIVERY DEVICE, ITS PREPARATION METHOD, AND USE OF A NON-WOVEN SHEET

BR112020000320B1BR 112020000320 B1BR112020000320 B1BR 112020000320B1BR-112020000320-B1

Abstract

The present invention relates to bio-erodible drug delivery devices, including one or more active agents and related methods. The devices are useful for administering a wide variety of agents over long periods of time.

Inventors

  • Garrett Whitfield
  • Idicula Mathew
  • Matthew Devlin
  • Anthony McVey

Assignees

  • HERA HEALTH SOLUTIONS, INC

Dates

Publication Date
20260317
Application Date
20180708
Priority Date
20170708

Claims (9)

  1. 1. A bioerodible drug delivery device, characterized in that it comprises a non-woven sheet having a length, width, and thickness, said sheet in a rolled configuration comprising multiple turns along an axis parallel to the length of the sheet and perpendicular to the width of the sheet, wherein the non-woven sheet comprises an electrospun bioerodible polymer and at least one active agent, wherein said non-woven sheet is electrospun from a solution comprising the bioerodible polymer at a concentration of 10 to 50 mg/mL, wherein the solution comprises the bioerodible polymer and the active agent in a weight ratio of 2.5:1 to 1:2.5, wherein the bioerodible polymer is poly(L-lactic acid), and wherein the active agent is etonogestrel.
  2. 2. Device according to claim 1, characterized in that it is configured so that, after implantation in a patient, a therapeutic amount of the active agent is released for a period of at least 24 months.
  3. 3. Device, according to claim 1 or 2, characterized in that the sheet has a width of 20 to 500 mm and comprises at least 2 turns of 50 mm width.
  4. 4. Device according to any one of claims 1 to 3, characterized in that the bioerodible polymer comprises poly(lactic acid) having a molecular weight of 50,000 to 2,500,000 g/mol.
  5. 5. Method for preparing the device, as defined in any one of claims 1 to 4, characterized in that it comprises: (a) applying an electrical voltage from a voltage source to a solution to form a charged solution, (b) forming at least one droplet of charged solution, wherein the charged solution includes etonogestrel and at least one bioerodible polymer, wherein the concentration of bioerodible polymer in the solution is from 0.1 to 100 mg/mL, (c) forming nonwoven fibers in a grounded collector spaced from the droplet along a first axis, and (d) converting the collected fibers to a coiled configuration.
  6. 6. Method according to claim 5, characterized in that the weight ratio of bioerodible polymer to active agent is 5:1 to 1:5.
  7. 7. Method according to claim 5 or 6, characterized in that the bioerodible polymer comprises a poly(lactic acid) selected from poly(L-lactic acid), poly(D-lactic acid), poly(D/L-lactic acid), their copolymers and combinations thereof.
  8. 8. Method, according to any one of claims 5 to 7, characterized in that the bioerodible polymer comprises poly(lactic acid) having a molecular weight of 50,000-2,500,000 g/mol.
  9. 9. Use of a nonwoven sheet having a length, width and thickness, said sheet in a rolled configuration comprising multiple turns along an axis parallel to the length of the sheet and perpendicular to the width of the sheet, wherein the nonwoven sheet comprises a bioerodible polymer and at least one contraceptive drug, characterized in that it is for the manufacture of a bioerodible drug delivery device, as defined in any one of claims 1 to 4, for preventing pregnancy in a mammal.

Description

Cross-reference to related request. [001] This application claims the benefit of U.S. Provisional Application 62/530,166, filed July 8, 2017, the contents of which are incorporated herein in their entirety. Field of Invention [002] The present invention relates, in some respects, to bioerodible implantable drug delivery devices and related methods. The devices are useful for administering any pharmaceutical agent over a prolonged period of time. Background [003] Many therapeutic drugs are used chronically, meaning a patient will take one or more dosage forms every day for extended and/or indefinite periods. For some patients, physically swallowing one or more pills every day can be inconvenient or impractical. For certain psychiatric drugs, patient non-adherence can also present challenges to consistent drug dosing. Implantable drug delivery devices can be implanted in a patient and gradually release one or more active substances over extended periods. In many cases, however, these devices are made from non-degradable materials and therefore must be surgically removed after the administration of the total drug content. [004] There is still a need to improve drug delivery devices for controlled administration of a wide variety of therapeutic drugs. There is still a need to improve drug delivery devices that are completely bio-erodible and therefore do not need to be removed at the end of drug administration. Brief Description [005] Bioerodible implantable drug delivery devices and related methods are disclosed herein. The devices can be used to administer a wide variety of agents, and are particularly suitable for the prolonged administration of drugs at a constant rate. As such, the devices are especially useful for the administration of contraceptives, hormone therapies, chemotherapeutic agents and veterinary drugs, among others. The devices include electrospun fibers mixed with one or more active agents to form a random sheet that is arranged in a coiled configuration in order to achieve the desired release and degradation rate. [006] The details of one or more embodiments are set forth in the descriptions below. Other features, objectives and advantages will be evident from the description and claims. Brief Description of the Figures [007] Figure 1A shows an exemplary embodiment of the bioerodible implantable drug delivery device. Figure 1B shows an exemplary embodiment of the bioerodible implantable drug delivery device having conical ends. [008] Figure 2 shows an exemplary fiber/drug sheet that is unrolled (left) and in a partially rolled configuration (right). [009] Figure 3 shows a photograph of an exemplary embodiment of a bioerodible implantable drug delivery device. Detailed Description [0010] Before the present devices and methods are disclosed and described, it should be understood that the devices and methods are not limited to specific synthetic methods, specific components, or particular compositions. It should also be understood that the terminology used in this document is intended to describe only particular embodiments and is not intended to be limiting. [0011] As used in the descriptive report and appended claims, the singular forms "a" and "the" include plural referents unless the context clearly indicates otherwise. Ranges may be expressed here as from "about" a specific value and/or to "about" another specific value. When this range is expressed, another modality includes from a particular value and/or to another particular value. Similarly, when values are expressed as approximations, by using the antecedent "about," it will be understood that the specific value forms another modality. It will further be understood that the endpoints of each of the ranges are significant both in relation to the other endpoint and independently of the other endpoint. [0012] "Optional" or "optionally" means that the event or circumstance described below may or may not occur, and that the description includes examples in which the said event or circumstance occurs and examples in which it does not occur. [0013] Throughout the description and claims of this descriptive report, the word "comprise" and variations of the word, such as "comprising" and "comprises," mean "including, but not limited to," and are not intended to exclude, for example, other additives, components, whole numbers, or steps. "Example" means "an example of" and is not intended to convey an indication of a preferred or ideal embodiment. "Such as" is not used in a restrictive sense, but for explanatory purposes. [0014] Components that can be used to execute the revealed methods and five systems are disclosed. These and other components are disclosed in this document, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed, although the specific reference of each of the various individual and collective combinations and permutations thereof cannot be explicitly disclosed, each i