Browse Prior Art Database

Sustained release formulations with gliclazide

IP.com Disclosure Number: IPCOM000132029D
Publication Date: 2005-Nov-29
Document File: 1 page(s) / 13K

Publishing Venue

The IP.com Prior Art Database

Abstract

Different sustained release formulations with the aim to test stability and dissolution behaviour of the produced tablets were prepared. Gliclazide formulations are usually prepared as formulations containing 30 or 60 mg of the active ingredient. The formulations differ in the chosen basifying agent, diluents, portion and ratio of hydroxypropylmethylcellulose (HPMC).

This text was extracted from a Microsoft Word document.
At least one non-text object (such as an image or picture) has been suppressed.
This is the abbreviated version, containing approximately 97% of the total text.

Sustained release formulations with gliclazide

Different sustained release formulations with the aim to test stability and dissolution behaviour of the produced tablets were prepared. Gliclazide formulations are usually prepared as formulations containing 30 or 60 mg of the active ingredient.  The formulations differ in the chosen basifying agent, diluents, portion and ratio of hydroxypropylmethylcellulose (HPMC). Some examples are given bellow:

  • Basifying agent CaCO3 or Mg CO3
  • Diluents: starch, microcrystalline cellulose, saccharose, lactose, mannitol, sorbitol
  • Total portion of HPMC (25 to 40%)
  • Ratio between HPMC K4M : HPMC K100LV is in range from 4:1 to 1:0.67

Formulatios

A

B

C

D

E

composition

% / tablet

% / tablet

% / tablet

% / tablet

% / tablet

Gliclazide

18,8

18,8

18,8

18,8

18,8

MgCO3

8,8

-

-

-

-

CaCO3

-

8,8

8,8

8,8

8,8

HPMC K4M

10,0

10,0

15,0

20,0

20,0

HPMC K100

LV

15,0

15,0

10,0

20,0

5,0

Diluents

45,9

45,9

45,9

30,9

45,9

Mg stearate

1,3

1,3

1,3

1,3

1,3

Aerosil 200

0,3

0,3

0,3

0,3

0,3

S

100,0

100,0

100,0

100,0

100,0

The tablets were prepared by wet granulation (water or ethanol), wherein Mg stearate and Aerosil can be added after the granulation, with subsequent tabletting of the dried tablet mass or by direct compression.

It was found out, that formulations A and B with different basifying agents exhibit similar and appropriate stability. If the total portion of HPMC is the same i.e. 25 % (formulations B, C, E) and the ratio between K4M and K100 LV is changed, the fa...