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Dosage form and method for the delivery of drugs of abuse

A kind of technology of pharmaceutical preparation and medicine, applied in the field of compositions for oral administration

Inactive Publication Date: 2009-02-18
ABBOTTGMBH & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Although there are many compositions, preparations and methods to deal with drug abuse, all compositions, preparations and methods have certain limitations more or less

Method used

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  • Dosage form and method for the delivery of drugs of abuse
  • Dosage form and method for the delivery of drugs of abuse
  • Dosage form and method for the delivery of drugs of abuse

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0148] The following is a description of an exemplary method for studying the dissolution rate of certain compositions in HCl and 20% aqueous ethanol. A similar approach can be used to study the dissolution rate in 40% aqueous ethanol.

[0149] Instrument: USP Dissolution Apparatus II (paddle)

[0150] Instrument: USP Dissolution Apparatus II (paddle)

Embodiment II

[0151] Various compositions of certain formulations are discussed in the following sections.

[0152] (i) The composition of certain studied Formulations 1-6 is summarized in Table 1. The formulation does not contain drugs of abuse; they are provided as a proof of concept.

[0153] In one embodiment of the invention, a comminuted, multi-particulate or powder mixture of the components may be fed into a co-rotating twin-screw extruder. In a preferred embodiment, a homogeneous powdery mixture of the components is fed into a co-rotating twin-screw extruder (18 mm screw diameter). Extrusion was carried out at 134° C. (melt temperature in the transient region of the extruder die) and a screw rotation of 114 rpm with a throughput of 1.5 kg per hour. A slightly off-coloured extrudate was obtained which was then fed into a calender to form long tablets weighing approximately 910 mg. The tablet was cooled to room temperature, ie about 25°C.

[0154] The dissolution behavior of the t...

Embodiment III

Method for Determining Tablet Breaking Strength:

[0180] A rectangular tablet with a diameter of about 5.1 mm to about 10 mm and a length of about 5.1 mm to about 30 mm is placed flat in the tablet holder so that the seam is lapped (away from the wedge), i.e., the breaking strength will be against the seam Take measurements. like Figure 7 As shown, the wedge-shaped cylinder is pushed vertically to the long side of the tablet, and the tablet is moved in at a constant speed until the tablet breaks. The force required to break the tablet is recorded. The maximum force that can be applied is 500 Newtons.

[0181] The instrument used for measurement is "Pharma Test PTB 501" hardness tester, Fmax = 500N, maximum tension 40mm, forward speed ~ 3mm / s. The measurements were carried out using a cylinder (14 mm diameter) with a wedge-shaped tip whose dimensions are described in Figure 8 middle. (All instruments are from Pharma Test Apparatebau, Hainburg, Germany).

[0182] The fo...

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Abstract

A dosage form and method for the delivery of drugs, particularly drugs of abuse, characterized by resistance to solvent extraction, tampering, crushing, or grinding, and providing an initial burst of release of drug followed by a prolonged period of controllable drug release.

Description

technical field [0001] The present invention relates to compositions for oral administration. The present invention preferably comprises at least one abuse-resistant drug delivery composition for administering a drug with abuse potential, related methods for preparing such dosage forms, and methods of treating a patient in need thereof, comprising administering a composition of the invention to the patient. Background technique [0002] Prescription drug abuse has become a public health problem in many communities. One common type of drug that suffers from abuse is the opioid type. In the United States, opioids are the predominant class of pain medication used in the management of moderate to severe pain because of their potency, ease of titration, and favorable risk-to-benefit ratio. [0003] One of the effects of opioid administration is the ability of these drugs to alter mood and affect in certain individuals in such a way that it can provide a desired sense of "well-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/485
CPCA61K9/2054A61K31/485A61K9/2095A61K9/2027A61K9/2031A61P25/04A61P25/36A61P29/02A61K9/20
Inventor J·布雷滕巴赫U·兰德J·罗森伯格M·梅格莱因G·维尔勒
Owner ABBOTTGMBH & CO
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