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

Balsalazide formulations and manufacture and use thereof

A technology of balsalazide and balsalazide disodium, which is applied in the directions of pill delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc.

Inactive Publication Date: 2012-09-19
SALIX PHARMA INC
View PDF4 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, patient compliance is an issue

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
  • Balsalazide formulations and manufacture and use thereof
  • Balsalazide formulations and manufacture and use thereof
  • Balsalazide formulations and manufacture and use thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0103] The preparation method of balsalazide tablet

[0104] Shown below is an exemplary method of preparing balsalazide tablets:

[0105] initial weighing

[0106] An appropriate amount of balsalazide disodium and other suitable excipients such as hypromellose and magnesium stearate are dispensed.

[0107] wet granulation

[0108] The balsalazide disodium hypromellose was granulated using a low shear (satellite) mixer. The wet granules were tray dried in an oven to a moisture level of about NMT 2.0%.

[0109] to grind

[0110] The dried granules are milled through a Fitzpatrick mill equipped with, for example, a #2AA mesh stainless steel screen with knives advancing at medium speed.

[0111] final mix

[0112] After milling, the compacted granules were charged to a V-blender and blended with magnesium stearate.

[0113] compression

[0114] The final blend was compressed into 1100 mg tablets using an automatic tablet press.

[0115] tablet coating

[0116] The compr...

Embodiment 1

[0153] Colazal Capsules, 750mg Dissolution Test

[0154] Material

[0155] High-purity water (18MΩ resistivity or higher)

[0156] Balsalazide disodium reference standard

[0157] Monobasic Sodium Phosphate, ACS Reagent Grade

[0158] 10N NaOH

[0159] Type 316 Stainless Steel Coil Hood, Laboratory Quality Accessory, Catalog Number: CAPWHT-4S

[0160] Gelman nylon filter, 25mm, 0.2μm pore size, Part No. 4436T

[0161] Vankel 10-µm full-flow filter, part number 17-400

[0162] Specifications (refer to current USP chapter )

[0163] Phase 1 After 30 minutes, each formulation unit must be not less than 75% dissolved (Q=70%)

[0164] Stage 2 After 30 minutes, the average of the 12 formulation units from Stage 1 and Stage 2 must be not less than 70% dissolved. After 30 minutes, each formulation unit must be not less than 55% dissolved.

[0165] Stage 3 After 30 minutes, the average of the 24 formulation units from stages 1, 2 and 3 must be not less than 70% dissolved. Aft...

Embodiment 2

[0209] For the arithmetic statistics of sample 1, figure 2 The data, arithmetic statistics characterizing the surface area, particle size and cumulative volume of a batch of drug (feed material) are shown and tabulated. The particle size distribution of this batch is in figure 2 shown in .

[0210] Sample 1:

[0211] Optical model: Fraunhofer.rfz

[0212] LS 200 small volume module

[0213] Calculation from 0.375μm to 2000μm

[0214] Volume: 100%

[0215] Average: 6.967μm

[0216] Median value: 5.584 μm

[0217] Specific surface area: 19389cm 2 / mL

[0218] %<10 25 50 75 100

[0219] μm 1.266 2.827 5.584 9.624 43.67

[0220] table 5

[0221]

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 sizeaaaaaaaaaa
particle sizeaaaaaaaaaa
particle sizeaaaaaaaaaa
Login to View More

Abstract

The invention relates to formulations and dosage schedules of balsalazide. The invention further relates to methods of producing pharmaceutical formulations of balsalazide.

Description

[0001] This application is a divisional application of the invention patent application with application number 200680030809.2 and application date of August 24, 2006. Background technique [0002] Balsalazide is a non-steroidal, anti-inflammatory aminosalicylate derivative used in the treatment of gastrointestinal disorders such as active ulcerative colitis, colon cancer and Crohn's disease. See eg WO95 / 18622, US6197341 and US6326364, all of which are incorporated herein by reference. [0003] One drawback of balsalazide is the relatively large dose, which makes it difficult to administer in a single dose. Balsalazide is also dark in color and has drawbacks when administered as a solution due to its tendency to stain the mouth. For compliance reasons, the large number of capsules that will be swallowed by the patient on a daily basis must be as small as possible. [0004] Currently, balsalazide is administered as 3 capsules 3 times daily. Therefore, patient compliance is a...

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): A61K31/655A61K9/48A61P31/04A61P1/00A61P35/00B01F23/70
CPCA61K9/16A61K9/14A61K31/609A61K9/4858A61K9/4808A61K9/4833A61P1/00A61P1/04A61P31/04A61P35/00A61P43/00A61P9/12A61K9/20A61K31/655A61K47/12A61K47/38
Inventor J·洛克哈特B·斯万森L·约翰逊
Owner SALIX PHARMA INC
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