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Dosage forms for administering combinations of drugs

A composition and drug technology, applied in the directions of drug combinations, antipyretics, anti-inflammatory agents, etc., can solve the problems of delayed drug action, low therapeutic effect, weakened absorption, etc.

Inactive Publication Date: 2009-04-15
POZEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Impaired absorption may lead to delayed onset of drug action and less than expected therapeutic effect

Method used

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  • Dosage forms for administering combinations of drugs
  • Dosage forms for administering combinations of drugs
  • Dosage forms for administering combinations of drugs

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0030] Preparation of pharmaceutical preparations

[0031] The pharmaceutical composition of the present invention includes tablets and capsules, which can be prepared according to standard methods in the art (see for example Remington's Pharmaceutical Sciences , 16 th ed., A Oslo editor, Easton, Pa. (1980)). Drugs and drug combinations will generally be prepared by blending with conventional excipients. Suitable carriers include, but are not limited to: water; saline solutions; alcohols; acacia; vegetable oils; benzyl alcohol; polyethylene glycol; gelatin; carbohydrates such as lactose, amylose, or starch; magnesium stearate; talc; silicon Acid; paraffin; aromatic oil; fatty acid ester; hydroxymethylcellulose; polyvinylpyrrolidone, etc. The pharmaceutical preparation can be sterilized, and if necessary, can also be mixed with adjuvants, such as: lubricants, preservatives, disintegrants; stabilizers; wetting agents; emulsifiers; salts; buffers; coloring agents; flavorin...

Embodiment 1

[0053] Example 1: Triptan and NSAID

[0054] This example describes a press-coated and press-coated tablet consisting of sumatriptan succinate within a core and naproxen sodium surrounding the core. refer to figure 1 The tablet is shown.

[0055] Table 4: Composition of the core (40mg sumatriptan)

[0056] Element

Mg / piece

Intragranular components

Sumatriptan Succinate, USP 1

56.0

Lactose monohydrate, NF

56.0

Purified water, USP 2

QS

extragranular components

Anhydrous lactose, NF

112.0

Microcrystalline Cellulose, NF

26.2

Croscarmellose Sodium, NF

2.54

Magnesium Stearate, NF

1.27

total

254.0

[0057] 1 56.0mg sumatriptan succinate equivalent to 40mg sumatriptan

[0058] 2 Purified water, USP is removed during drying

[0059] Table 5: Composition of the core outer layer (500 mg naproxen sodium)

[0060] Element ...

Embodiment 2

[0066] Example 2: Opioid pain relievers and NSAIDs

[0067] This example describes a bilayer tablet consisting of sustained release hydrocodone and naproxen sodium. refer to figure 2 Schematic of the tablet or reference Figure 5 Tablets containing pellets are indicated.

[0068] Table 6: Composition of layer 1 (10 mg hydrocodone tartrate)

[0069] Element

Mg / piece

Intragranular components

Hydrocodone Tartrate, USP

10.0

Microcrystalline Cellulose, NF

37.5

Povidone, USP

15.0

Hydroxypropyl Methyl Cellulose (Methocel K4M)

45.0

Purified water, USP 1

QS

extragranular components

Microcrystalline Cellulose, NF

45.0

Magnesium Stearate, NF

1.5

total

154.0

[0070] 1 Purified water, USP is removed during drying

[0071] Table 7: Composition of layer 2 (400 mg naproxen sodium)

[0072] Element

Mg / piece

Int...

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PUM

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Abstract

The present invention is directed to dosage forms that can be used in therapeutic methods involving the oral co-administration of a combination of at least two drugs, one of which impairs gastrointestinal absorption and one of which does not. The dosage forms are designed so that the drug impairing absorption is not released into the gastrointestinal tract of a patient until after the drugs that do not impair absorption have been released and substantially absorbed. The invention may be used in treatment of migraine using a combination of triptans and NSAIDs or in the treatment of pain using a combination of NSAIDs and opioid analgesics.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to and benefits of US Provisional Application 60 / 779,373, filed March 6, 2006, which is hereby incorporated by reference in its entirety. field of invention [0003] The present invention relates to dosage forms for oral co-administration of drugs where at least one drug impairs gastrointestinal absorption in the patient and at least one other drug does not impair gastrointestinal absorption in the patient. The dosage form delays the release of the drug that impairs absorption until after the drug that does not impair absorption is at least partially absorbed. Thus, the overall speed and efficiency of drug delivery is increased. Such dosage forms would be of particular value for pharmaceutical compositions combining a non-narcotic analgesic with a triptan or opioid analgesic. Background of the invention [0004] Where higher doses of a single drug would have no therapeutic benefit or ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24
CPCA61K9/209A61K31/485A61K31/542A61K45/06A61P25/04A61P29/00
Inventor J·R·普拉赫特卡D·L·吉尔伯特
Owner POZEN INC
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