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Process for manufacturing drug delivery formulations

A drug and drug technology, applied in the field of preparing drug delivery products, can solve unmet problems

Active Publication Date: 2015-04-29
O RAY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As such, there remains an unmet need in the art for pharmaceutical products that provide controlled and / or sustained release of drug to a target area

Method used

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  • Process for manufacturing drug delivery formulations
  • Process for manufacturing drug delivery formulations
  • Process for manufacturing drug delivery formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090] In vitro release of gentamicin

[0091] In vitro studies were performed to demonstrate the release of highly soluble gentamicin sulfate from the packaged silicone cups. solid drug granules ( figure 1 , 105) dip-coated with polylactic acid, and packaged in silicone cups ( figure 1 , 101). The drug can be released from only one end of the silicone, which is then coated with a controlled-release polymer formulation of parylene ( figure 1, 107) to control its release. Two grams of parylene were loaded into the vaporization chamber to create an extended release formulation. Release was tested using conventional dissolution systems. Briefly, dissolutions were performed in 2 ml of distilled water in 2 ml polypropylene microcentrifuge tubes at room temperature without agitation. During the course of 7 days, 40 [mu]l samples of gentamicin were taken at different time intervals and the concentration at each time point was measured by comparing the absorbance of the samples ...

Embodiment 2

[0102] In vivo release of gentamicin

[0103] Gentamicin sulfate-releasing implants prepared as described in Example 1 were implanted in the round window niche of juvenile albino guinea pigs. Pharmacokinetics: Perilymph samples were collected 1 day, 4 days, 7 days and 10 days after gentamicin implant placement and assayed for gentamicin sulfate (HPLC, reverse phase, with AB SCIEX API 3000MS Agilent 1100 Series HPLC / MS).

Embodiment 3

[0105] In vitro release of immunoglobulin G

[0106] In vitro studies were performed to demonstrate the release of highly soluble immunoglobulin G (IgG) from the packaged silicone cups. Solid drug particles were produced by mixing 75% IgG with 25% hydroxypropylmethylcellulose (HPMC) ( Figure 4 , 402). The solid particles are packaged in silicone cups ( figure 1 , 101). The drug can be released from only one end of the silicone, which is then coated with 5 μl of a controlled release polymer formulation of 10% polylactic acid ( figure 1 , 107) to control its release. Dissolution studies were performed using IgG packaged extended release formulations. For each sample, release into 600 μl of water was performed at room temperature (23° C.) with stirring. Aliquots were taken intermittently and analyzed by UV absorption spectroscopy at 280 nm using a Spectramax Plus 384 96-well microplate reader. Extended release formulations of packaged IgG demonstrated drug dissolution ove...

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Abstract

The present invention provides for methods of producing a drug product that is capable of providing controlled and sustained release of a drug. Particularly, the release of the drug will be to a specific tissue area in the body. The methods include, but are not limited to, providing an impermeable casing with an open end, placing a compressed drug pellet into the impermeable casing, coating the open end of the impermeable casing with a permeable layer to create a release window for the drug product to provide controlled and / or sustained release of the drug.

Description

technical field [0001] The present invention relates to a method for the preparation of a drug delivery product. Background technique [0002] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information useful for understanding the present invention. It is not an admission that any of the information presented herein is prior art or relevant to the presently claimed invention, or that any publication cited, either explicitly or implicitly, is prior art. [0003] Meniere's disease is an inner ear disorder that causes spontaneous episodes of vertigo, with fluctuating hearing loss, ringing in the ears (tinnitus), and sometimes a feeling of swelling or pressure in the ear (aural stuffiness). There is currently no cure for Meniere's disease, but some treatment options may help manage symp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M31/00A61K9/22
CPCA61K9/0046A61K9/1652A61K9/5021A61K9/5031A61K9/5073A61K31/00A61K31/56A61K9/0092A61K9/20A61K9/2054A61K9/2853A61K9/2886A61K9/2893A61K31/7036A61J3/00A61K9/4808A61K9/4816A61K9/4833A61K9/4891A61K47/34A61K47/38C07K16/18C07K16/241
Inventor E·皮尔斯托夫W·H·斯莱特里
Owner O RAY PHARMA