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Methods and devices for providing prolonged drug therapy

A technology of drug and drug layer, which is applied in the field of immediate release drug dosage forms and osmotic dosage forms, and can solve the problems of reduced therapeutic effect of drugs

Inactive Publication Date: 2005-07-06
ALZA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been observed that in some patients receiving constant release dosage forms for the treatment of certain conditions or diseases, the therapeutic effect of the drug decreases before the completion of a satisfactory treatment period, although achieving a substantially constant drug release is expected to provide sustained efficacy

Method used

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  • Methods and devices for providing prolonged drug therapy
  • Methods and devices for providing prolonged drug therapy
  • Methods and devices for providing prolonged drug therapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Bilayer oral osmotic dosage forms are prepared according to conventional manufacturing methods known in the art and described in detail in co-pending US Application No. 967,606, filed November 10, 1997, of which this application is a continuation-in-part. Briefly, a first component layer containing methylphenidate hydrochloride and selected excipients and a second propulsion layer containing a suitable osmopolymer, 40 wt. layer. The first component layer and the second push layer granulation formulation are then longitudinally compressed together to form a bilayer LCT core. A selected semipermeable membrane was then wrapped around the bilayer LCT core, forming suitable 30 mil pores through the membrane into the first component layer for drug release.

[0069] Each dosage form prepared contains:

[0070] first layer

[0071] 14.08mg methylphenidate hydrochloride

[0072]90.26mg polyethylene oxide (number average molecular weight 200,000)

[0073] 5.5mg polyvinylpy...

Embodiment 2

[0089] Bilayer oral osmotic dosage forms are prepared according to conventional manufacturing methods known in the art and described in detail in co-pending US Application No. 967,606, filed November 10, 1997, of which this application is a continuation-in-part. Briefly, a first component layer containing methylphenidate hydrochloride, sorbitol and selected excipients and a second layer containing a suitable osmopolymer, 40 wt. Two propulsion layers. The first component layer and the second push layer granulation formulation are then longitudinally compressed together to form a bilayer LCT core. A selected semipermeable membrane was then wrapped around the bilayer LCT core, forming suitable 30 mil pores through the membrane for drug release.

[0090] Each dosage form prepared contains:

[0091] The first ingredient layer (110mg)

[0092] 12.8% Methylphenidate Hydrochloride

[0093] 54.75% polyethylene oxide (number average molecular weight 200,000)

[0094] 25.4% Sorbit...

Embodiment 3

[0113] According to conventional preparation methods known in the art and described in detail in pending U.S. application No. 967,606 filed on November 10, 1997 (this application is a continuation-in-part thereof), a bilayer oral osmotic dosage form is prepared, which dosage form Also included is an immediate release drug dose coated on a semipermeable membrane. Briefly, a first component layer containing methylphenidate hydrochloride, sorbitol, and selected excipients and a second layer containing a suitable osmopolymer, 39.8 wt. Two propulsion layers. The first component layer and the second push layer granulation formulation are then longitudinally compressed together to form a bilayer LCT core. A selected semipermeable membrane was then wrapped around the bilayer LCT core, forming suitable 30 mil pores through the membrane for drug release. A drug-containing coat mixture is prepared and coated on the semipermeable membrane of the osmotic dosage form. Optionally, an odor...

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PUM

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Abstract

Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended period of time are provided. The dosage forms may additionally comprise an immediate-release dose of drug. <IMAGE>

Description

background of the invention [0001] The present invention relates to therapeutic methods and devices for maintaining the desired therapeutic effect of a drug over an extended period of time. In particular, the present invention relates to methods and devices for providing drug release in the gastrointestinal tract over prolonged periods of time at elevated release rates. In this way, the drug is released at an elevated rate over a portion of the administration period sufficient to maintain the desired therapeutic effect of the drug throughout the extended treatment period. [0002] A description of relevant technology including disclosed information under 37 CFR 1.97 and 1.98 [0003] To produce a pharmacological effect, a drug must reach an appropriate concentration at its site of action in the body. The availability of a drug is influenced by numerous factors, including the amount administered, the extent and rate of absorption from its site of administration, its distribut...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/22A61K31/21A61P25/14A61KA61K31/137A61K31/421A61K31/4402A61K31/4422A61K31/4458A61K47/02A61K47/34A61K47/38A61P25/00
CPCA61K9/0004A61K31/137A61K31/421A61K31/4402A61K31/4422A61K31/4458G01N21/9508A61P25/00A61P25/14A61K9/20A61K31/21
Inventor A·D·艾尔C·A·克里斯朵夫D·R·金塔S·K·古普塔L·G·哈梅尔Z·哈特姆哈内A·C·兰S·R·萨克斯P·沙瓦南德R·G·魏尔斯J·D·赖特
Owner ALZA CORP
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