Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Orally disintegrating tablet comprising roflumilast

A technology of orally disintegrating tablets and roflumilast, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2013-10-02
BEIJING VENTUREPHARM BIOTECH
View PDF5 Cites 8 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The FDA approved roflumilast for the treatment of chronic obstructive pulmonary disease in February 2011. It is sold in the European Union and the United States in the form of roflumilast film-coated tablets and ordinary tablets, but there are no reports of orally disintegrating tablet dosage forms.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Orally disintegrating tablet comprising roflumilast
  • Orally disintegrating tablet comprising roflumilast
  • Orally disintegrating tablet comprising roflumilast

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0025] Specific Example 1 Roflumilast Orally Disintegrating Tablets (1000 Tablets)

[0026] 0.125g

[0027] Mannitol (co-micronized with Ro) 12.5g

[0028] Mannitol 26.275

[0029] Microcrystalline Cellulose 30g

[0030] Low-substituted hydroxypropyl cellulose 8g

[0031] Hypromellose 0.6

[0032] Acesulfame K 1.0g

[0033] Peppermint essence 1.0g

[0034] Magnesium stearate 0.5g [Microsoft User 1]

[0035] Preparation method: 1. Micronize the active ingredients Ro and mannitol in the prescription according to the prescription ratio.

[0036] 2. Mix the prescribed amount of Ro with mannitol, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose in a mixer.

[0037] 3. Add 60% alcohol solution of 2% hypromellose to the above mixture to make soft material and granulate.

[0038] 4. Dry until moisture L.O.D (90...

specific Embodiment 2

[0040] Specific Example 2 Roflumilast Orally Disintegrating Tablets (1000 Tablets)

[0041] Roflumilast (Ro) 0.125g

[0042] Mannitol (co-micronized with Ro) 0.625g

[0043]Mannitol 38.15

[0044] Microcrystalline Cellulose 30g

[0045] Low-substituted hydroxypropyl cellulose 8g

[0046] Hypromellose 0.6

[0047] Acesulfame K 1.0g

[0048] Peppermint essence 1.0g

[0049] Magnesium stearate 0.5g

[0050] Preparation method: 1. Micronize the active ingredients Ro and mannitol in the prescription according to the prescription ratio.

[0051] 2. Mix the prescribed amount of Ro with mannitol, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose in a mixer.

[0052] 3. Add 60% alcohol solution of 2% hypromellose to the above mixture to make soft material and granulate.

[0053] 4. Dry until moisture L.O.D (90°C, 5min) < 3%, granulate, add...

specific Embodiment 3

[0054] Specific Example 3 Roflumilast Orally Disintegrating Tablets (1000 Tablets)

[0055] Roflumilast (Ro) 0.125g

[0056] Mannitol (co-micronized with Ro) 6.25g

[0057] Mannitol 32.525

[0058] Microcrystalline Cellulose 30g

[0059] Low-substituted hydroxypropyl cellulose 8g

[0060] Hypromellose 0.6

[0061] Acesulfame K 1.0g

[0062] Peppermint essence 1.0g

[0063] Magnesium stearate 0.5g

[0064] Preparation method: 1. Micronize the active ingredients Ro and mannitol in the prescription according to the prescription ratio.

[0065] 2. Mix the prescribed amount of Ro with mannitol, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose in a mixer.

[0066] 3. Add 60% alcohol solution of 2% hypromellose to the above mixture to make soft material and granulate.

[0067] 4. Dry until moisture L.O.D (90°C, 5min) <...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
particle diameteraaaaaaaaaa
viscosityaaaaaaaaaa
hardnessaaaaaaaaaa
Login to View More

Abstract

The invention belongs to the field of medicine technology, and relates to an orally disintegrating tablet comprising roflumilast and a preparation method of the orally disintegrating tablet. The orally disintegrating tablet comprises roflumilast, a hydrophilic filler, a water-soluble polymer adhesive, a disintegrating agent, a flavouring agent, a lubricant, and the like. The objective of the invention is to provide the roflumilast orally disintegrating tablet that has advantages of simple preparation technology, taking convenience, rapid effect, rapid concentration peak and obvious curative effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a rapidly disintegrating orally disintegrating tablet whose active ingredient is roflumilast and a method for producing the dosage form. Background technique [0002] Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation. Airflow limitation is not fully reversible, progressive, and associated with an abnormal inflammatory response of the lungs to noxious gases or particles, such as cigarette smoke. COPD is a progressive and life-threatening lung disease. It is one of the "killers" of human health, which makes patients have difficulty breathing and loses their ability to move. This disease often includes chronic bronchitis and emphysema. It is estimated that approximately 210 million people worldwide suffer from the disease, and COPD is expected to become the third leading cause of death glob...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/44A61P11/00A61P29/00
Inventor 付珊珊黄雪任广智
Owner BEIJING VENTUREPHARM BIOTECH
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com