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Dronedarone hydrochloride osmotic pump type controlled release tablet

A dronedarone hydrochloride and osmotic pump technology, which is applied in the field of dronedarone osmotic pump controlled-release tablets, can solve the problems of large side effects, low blood drug concentration, and low bioavailability of patients

Inactive Publication Date: 2017-10-24
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cause the low bioavailability of dronedarone hydrochloride gastrointestinal administration, so must find the method that can improve the dissolution rate of dronedarone hydrochloride, to improve its bioavailability
In addition, the common dosage form can reach a high plasma peak concentration in a short period of time after taking it, and the blood drug concentration is very low when the next medication is taken, especially in the early morning when the local ischemia is the most serious, the curative effect of the common dosage form is poor, and the harm brought to the patient side effects

Method used

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  • Dronedarone hydrochloride osmotic pump type controlled release tablet
  • Dronedarone hydrochloride osmotic pump type controlled release tablet
  • Dronedarone hydrochloride osmotic pump type controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] 1. Prescription

[0048] 1) Tablet core prescription, based on 1000 tablets:

[0049] Drug-containing layer:

[0050] Dronedarone Hydrochloride 200-500g

[0051] Lactose 320g

[0052] Cyclodextrin 80g

[0053] Microcrystalline Cellulose 120g

[0054] Polyethylene glycol 50g

[0055] Microcrystalline Cellulose 32g

[0056] Magnesium Stearate 2g

[0057] Boost layer:

[0058] Hydroxypropyl Methyl Cellulose 130g

[0059] Magnesium chloride 80g

[0060] Lactose 100g

[0061] Cellulose acetate 60g

[0062] Magnesium Stearate 1g

[0063] 2) Prescription of semi-permeable membrane coating solution

[0064] Cellulose acetate 74g

[0065] Polycarbonate 33g

[0066] Ethanol 1000ml

[0067] 3) Prescription of film coating solution

[0068] Gastric coating powder 10g

[0069] water 100ml

[0070] 2. Detailed preparation process

[0071] 1. Preparation process of dronedarone hydrochloride tablet core: The tablet core is a double-layer tablet, one layer is a drug-...

Embodiment 2

[0080] 1. Prescription

[0081] 1) Tablet core prescription, based on 1000 tablets:

[0082] Drug-containing layer:

[0083] Dronedarone Hydrochloride 200-500g

[0084] Lactose 320g

[0085] Cyclodextrin 80g

[0086] Microcrystalline Cellulose 120g

[0087] Polyethylene glycol 50g

[0088] Microcrystalline Cellulose 32g

[0089] Magnesium Stearate 2g

[0090] Boost layer:

[0091] Hydroxypropyl Methyl Cellulose 130g

[0092] Magnesium chloride 80g

[0093] Lactose 100g

[0094] Cellulose acetate 60g

[0095] Magnesium Stearate 1g

[0096] 2) Prescription of semi-permeable membrane coating solution

[0097] Cellulose acetate 74g

[0098] Polycarbonate 31g

[0099] Ethanol 1000ml

[0100] 3) Prescription of film coating solution

[0101] Gastric coating powder 10g

[0102] water 100ml

[0103] Two, detailed preparation process is the same as embodiment 1

Embodiment 3 1

[0104] Embodiment 3 One, prescription

[0105] 1) Tablet core prescription, based on 1000 tablets:

[0106] Drug-containing layer:

[0107] Dronedarone Hydrochloride 200-500g

[0108] Lactose 320g

[0109] Cyclodextrin 80g

[0110] Microcrystalline Cellulose 120g

[0111] Polyethylene glycol 50g

[0112] Microcrystalline Cellulose 32g

[0113] Magnesium Stearate 2g

[0114] Boost layer:

[0115] Hydroxypropyl Methyl Cellulose 130g

[0116] Magnesium chloride 80g

[0117] Lactose 100g

[0118] Cellulose acetate 60g

[0119] Magnesium Stearate 1g

[0120] 2) Prescription of semi-permeable membrane coating solution

[0121] Cellulose acetate 74g

[0122] Polycarbonate 35g

[0123] Ethanol 1000ml

[0124] 3) Prescription of film coating solution

[0125] Gastric coating powder 10g

[0126] water 100ml

[0127] Two, detailed preparation process is the same as embodiment 1

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Abstract

The invention provides a novel dronedarone hydrochloride osmotic pump-type controlled-release tablet, which adopts cellulose acetate and polycarbonate as semipermeable membrane film-forming materials, which can overcome the semipermeable membrane aging phenomenon, obtain a stable release rate, and Reduce drug residues. The dronedarone oral osmotic pump preparation provided by the present invention has excellent release performance and high stability, and there is no obvious aging phenomenon after being placed for a long time, which meets the market demand.

Description

technical field [0001] The invention relates to a dronedarone osmotic pump-type controlled-release tablet, which uses cellulose acetate-polycarbonate as a semipermeable membrane material and belongs to the field of pharmaceutical preparations. Background technique [0002] Dronedarone hydrochloride, English name: Dronedarone hydrochloride, its CAS number is 141625-93-6, its chemical name is N-[2-n-butyl-3-[4-[3-(di-n-butylamino)propane Oxygen]benzoyl]-5-benzofuryl]methanesulfonamide hydrochloride is an antiarrhythmic drug developed by Sanofi-Aventis in France, which has a similar structure and Electrophysiological effects, but it does not contain iodine, so it will not cause adverse reactions related to iodine, and it is an alternative to the latter. In July 2009, it was first launched in the United States with FDA approval. This product is suitable for cardiac rhythm control, maintenance of sinus rhythm and slowing of ventricular rhythm in patients with atrial fibrillatio...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K9/24A61K31/343A61K47/38A61K47/32A61P9/06
CPCA61K9/2086A61K9/282A61K31/343A61K47/34A61K47/38
Inventor 严洁
Owner TIANJIN HANKANG PHARMA BIOTECH
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