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Drug delivery methods, structures, and compositions for nasolacrimal system

A support structure and tear point technology, applied in the field of implants, can solve the problems of patients with vision loss, blindness, and no drug release from implants, etc.

Active Publication Date: 2009-08-12
MATI THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While this approach may provide some improvement over eye drops, some potential issues with this approach may include implantation of the implant at the desired tissue site, retention of the implant at the desired tissue site, and drug delivery in the desired tissue site. Sustained release at desired therapeutic levels over an extended period of time
For example, in the case of glaucoma treatment, missed diagnosis and premature loss of the implant can result in no drug being released and the patient could potentially suffer vision loss and possibly even blindness

Method used

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  • Drug delivery methods, structures, and compositions for nasolacrimal system
  • Drug delivery methods, structures, and compositions for nasolacrimal system
  • Drug delivery methods, structures, and compositions for nasolacrimal system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 11

[0135] Embodiment 1.1 Dissolution data of latanoprost drug core

[0136] The drug cores described above were prepared with different cross-sectional dimensions of 0.006 inches, 0.012 inches, and 0.025 inches, and with drug concentrations of 5%, 10%, and 20% in the silicone matrix. These cores can be prepared using a syringe and cartridge device by mixing latanoprost with silicone and injecting this mixture into polyimide tubes that are cut to length and sealed. The length of the drug core is about 0.80 to 0.95 mm, corresponding to about 3.5 μg, 7 μg and 14 μg of The total latanoprost content contained in the drug core.

[0137] Syringe and cartridge set. 1. Take polyimide tubing of three different diameters: 0.006 inches, 0.0125 inches, and 0.025 inches. 2. Cut polyimide tubing of different diameters into ~15 cm lengths. 3. Insert the polyimide tubing into the syringe adapter. 4. Adhesive bond polyimide tubing into thick needle connector (Loctite, low viscosity UV curable...

Embodiment 2

[0149] Example 2 Dissolution data of cyclosporin drug core

[0150] The drug core in Example 1 above was prepared with cyclosporine having a concentration of 21.2%. Figure 8A The dissolution profile of cyclosporin according to an embodiment of the present invention from a drug core into a buffer without and with a surfactant is shown. The buffer was prepared as described above. The solution with surfactant consisted of 95% buffer and 5% surfactant, UP-1005 Ultra Pure Fluid was obtained from Dow Corning, Midland, Michigan. Studies related to embodiments of the present invention have shown that, in at least some cases, surfactants can be used in vitro to simulate in situ dissolution from the eye, since the eye can include natural surfactants in the tear film, e.g. Surfactant protein D. The dissolution profile of cyclosporine into the surfactant was about 50-100 ng / day from 30 to 60 days. Empirical data from patient populations eg 10 patient tears can be determined and used ...

Embodiment 3

[0151] Example 3 Total dissolution data of bimatoprost

[0152] A total sample of 1% bimatoprost was prepared with a known diameter of 0.076 cm (0.76 mm). The height of each sample was determined from the weight of the sample and the known diameter.

[0153] Table 2 Total sample size

[0154]

sample

wt(mg)

diameter (cm) calculate height

(cm) exposed surface

Product (cm^2) 14-2-10 1.9 0.076 0.42 0.109 14-2-11 1.5 0.076 0.33 0.088 14-2-12 1.9 0.076 0.42 0.109

[0155] The calculated height is 0.33cm-0.42cm. For 0.42 and 0.33cm samples, if they are 0.019cm 3 and 0.015cm 3 volume, the exposed surface area of ​​each end of each total sample is 0.045cm 2 . The exposed surface area of ​​the exposed sample without drug sheath calculated from height and diameter is about 0.1 cm 2 . Three formulations were evaluated: 1) Silicone 4011, 0.1% bimatoprost, 0% surfactant; 2) Silicone 4011, 1% bimatoprost, approximatel...

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Abstract

An implant which is provided by the invention for being inserted into the lacrimal punctum of patient comprises a main body. The main body comprises a distant end, a near end and a shaft between the distant end and the near end. The distant end of main body can be inserted into the inner cavity of lacrimal duct to the distant end through the lacrimal punctum. The main body comprises a therapeuticagent included in the flux core of pharmaceutical base. The exposing of pharmaceutical base to the tear causes that the effective therapeutic agent is released into the tear in duration. The main body is provided with a sheath which is configured on the pharmaceutical base for inhibiting the releasing of agent from the near end. The body is also provided with an outer surface which is combined with the tissue of inner cavity wall that restricts the discharging of tissue of inner cavity wall. In a specific execution mode, the pharmaceutical base comprises a non-biological absorptive polymer, such as the silicone in the non-homogeneous phase compound comprising the agent.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Application No. 60 / 787,775, filed March 31, 2006, and U.S. Provisional Application No. 60 / 871,864, filed December 26, 2006, under 35 USC 1 19(e), which The entire disclosure is hereby incorporated by reference. technical field [0003] The present application relates to implants for use in or around nasolacrimal drainage systems, and in particular provides canaliculus implants, lacrimal sac implants, punctal plugs and punctal plugs with drug delivery capabilities. Background technique [0004] In the field of ocular drug delivery, patients and physicians face various challenges. Specifically, the reproducibility of treatment (multiple injections per day, multiple eye drop regimens), associated costs, and lack of patient compliance can significantly affect the likely efficacy of treatment, leading to vision loss, many times Can cause blindness. [0005] When rec...

Claims

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Application Information

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IPC IPC(8): A61F2/12A61F2/14
CPCA61K31/5575A61F2250/0067A61F9/00772A61K9/0051A61K47/34A61F9/0017A61F9/0026
Inventor 小尤金·德朱昂卡里·赖希斯蒂芬·博伊德汉森·S·吉福德马克·迪姆
Owner MATI THERAPEUTICS
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