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Stable non-aqueous single phase viscons vehicles and formulations utilizing such vehicles

A non-aqueous, carrier-based technology, applied in the field of stable uniform mixed preparations, which can solve problems such as toxicity

Inactive Publication Date: 2002-03-13
INTARCIA THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These peroxides have no effect on protein stability [22], but can be toxic, especially when administered directly to the central nervous system of humans or animals

Method used

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  • Stable non-aqueous single phase viscons vehicles and formulations utilizing such vehicles
  • Stable non-aqueous single phase viscons vehicles and formulations utilizing such vehicles
  • Stable non-aqueous single phase viscons vehicles and formulations utilizing such vehicles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Preparation of non-aqueous single-phase viscous vehicles

[0095]The non-aqueous single-phase adhesive vehicles will be prepared below and are shown in the table below. A. Glyceryl monolaurate (Danisco Ingredients, New Century, Kansas) (25 g) was dissolved in lauryl lactate (ISP Van Dyk Co., Belleville, NJ) (35 g) at 65°C. Polyvinylpyrrolidone C30 (BASF, Mount Olive, NJ) (40 g) was added and the mixture was mixed with a double helical blade mixer (D.I.T) at 40 rpm until a single phase was obtained. Vacuum was used in the mixing chamber to remove air bubbles. Remove the single-phase support from the mixer and allow to cool to room temperature. B. Glyceryl monolaurate (Danisco Ingredients, New Century, Kansas) (25 g) was dissolved in lauryl lactate (ISP Van Dyk Co., Belleville, NJ) (35 g) at 65°C. Polyvinylpyrrolidone C17 (BASF, Mount Olive, NJ) (40 g) was added and the mixture was mixed with a double helical blade mixer (D.I.T) at 40 rpm until a single pha...

Embodiment 2

[0105] hGH

[0106] A. Preparation by spray drying method

[0107] Lyophilized hGH (BressaGen, Adelaide, Australia) was reconstituted with 150 ml deionized water. This stock solution contained 1050 mg hGH. Use Amicon Diaoflo  Ultrafiltration membranes (molecular weight cut-off 1000) were used for buffer exchange. The ultrafiltration cell was connected to an auxiliary reservoir containing 5 mM phosphate buffer (pH 7). The fluid volume of the ultrafiltration cell and the concentration of hGH were kept constant as the phosphate buffer replaced the excipients.

[0108] The ultrafiltered protein solution (wherein the protein concentration is about 2%) was spray dried with a YAMATO small spray dryer. The settings of the spray dryer are as follows: the aspiration pressure is usually set at 1.3kgf / cm 2 , the inlet temperature was 120° C., and the spray rate was 2.5 (about 3 ml / min). Collect the powder with the collector's centrifugal catcher. Handling of t...

Embodiment 4

[0126] preparation depot

[0127] release rate graph

[0128] A titanium depot system implanted in a drug delivery device (as disclosed in patent application US08 / 595761, incorporated herein by reference) was equipped with an osmotic engine, a piston, and a release-controlling membrane. The appropriate amount of viscous carrier formulation is filled into the reservoir and plugged with a flow plug. The system was placed in a 37°C water bath to allow sustained release of the formulation. Released substances were sampled twice a week. Released substances were analyzed by reversed-phase high-performance liquid chromatography. Concentrations of beneficial substances in each system were converted into daily releases. Such as Figure 3-8 As shown, the release of the beneficial agent from the implanted drug delivery device is zero order release.

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PUM

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Abstract

This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at an exit shear rate of between about 1 to 1 x 10<7> reciprocal second.

Description

field of invention [0001] The present invention relates to stable non-aqueous single-phase adhesive biocompatible carriers that can suspend beneficial substances and uniformly disperse said substances at low flow rates, and in particular relate to beneficial substances in a stable non-aqueous single-phase biocompatible viscosity A stable homogeneously mixed formulation in a carrier. references [0002] The numbers in square brackets ([ ]) in relevant parts of this specification refer to the following documents. 1. Wang, et al. J. Parenteral Sci. Tech., 42: S4-S26 (1988). 2. Desai, et al. J. Am. Chem. Soc., 116:9420-9422 (1994). 3. Chang, et al. Pharm. Tech., pp. 80-84 (June, 1996). 4. Manning, et al. Pharm. Res., 6:903-918 (1989). 5. Hageman, Drug Dev. Ind. Pharm, 14:2047-2070 (1988). 6. Bell,. Biopolymers, 35:201-209 (1995) 7. Zhang, et al. Pharm. Res., 12:1447-1452 (1995). 8. PCT Publication No. 98 / 001589. PCT Publication No. 981625010. Knepp, et al. Pharm. Res., 15(7...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K9/00A61K9/19A61K38/27A61K38/51A61K47/10A61K47/12A61K47/14A61K47/22A61K47/32A61K47/34A61K47/44A61P5/10
CPCA61K9/0024A61K9/0004A61K9/19A61K47/32A61K47/44A61K47/12A61K47/14A61K47/10A61P5/06A61P5/10A61K9/10
Inventor S·A·拜瑞P·J·费瑞拉H·迪纳德A·姆啻尼克
Owner INTARCIA THERAPEUTICS INC
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