Rapidly disintegrating dosage form comprising magnesium carbonate heavy

A heavy magnesium carbonate, dosage form technology, applied in the directions of pill delivery, drug combination, drug delivery, etc., can solve the problems of no provision, unpleasantness, etc.

Inactive Publication Date: 2008-02-27
ACTAVIS GRP PTC EHF
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, effervescent tablets are not suitable for use as orodispersible tablets because the effervescent action (production of carbon dioxide) in the mouth is often unpleasant
[0011] Unfortunately, the above invention does not provide a general method, that is, the process of wet granulation and direct compression is used for the formulation of both tablets, and the composition can be used for both orodispersible tablets and dispersible tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Fractions containing lamotrigine when wet granulated with heavy magnesium carbonate or mannitol Comparison of disintegration times of bulk tablets

[0050] The particle size of lamotrigine was: 99.2% smaller than 120 μm and 5% smaller than 10 μm.

[0051] Table 1: Tablets Containing Magnesium Carbonate Heavy

[0052] Element

mg / tablet

1

Lamotrigine

5

2

Heavy Magnesium Carbonate

122

3

Microcrystalline Cellulose (Avicel PH-102)

29

4

Polyvinylpyrrolidone

4

5

Low Substituted Hydroxypropyl Cellulose (L-HPC, LH-11)

8

6

sodium saccharin

2

[0053] 7

Polyvinylpolypyrrolidone (Polyplasdone XL-10)

8

8

pure water

Appropriate amount

9

Polyvinylpolypyrrolidone (Polyplasdone XL-10)

8

10

Microcrystalline Cellulose + Guar Gum (Avicel CE-15)

10

11

Blackcurrant...

Embodiment 2

[0067] Biological Study on Lamotrigine Dispersible Tablets

[0068] This biological study was a comparable, randomized, single-dose, two-way crossover bioavailability study: (A) Actavis Lamotrigine 5 mg dispersible tablet (made according to Example 1a), (B) Lamictal(R) (Glaxo History grams) 5mg dispersible tablets were administered to 24 healthy subjects under fasting conditions. The result is as follows:

[0069] Table 3: Pharmacokinetic parameters

[0070] AUC o-t 3

AUC o-lnf

C max

ratio 1

90% geometric confidence interval 2

Within-subject CV

103.79％

100.98％-106.69％

5.55％

103.69％

100.53％-106.95％

6.25％

103.57％

97.39％-110.14％

12.64％

[0071] 1 Calculated with the least square mean according to the formula: e (拉莫三嗪(A)-Lamictal(B) ×100

[0072] 2 Using the 90% confidence interval of the In-transformed value

[0073] 3t is 120 hours

[0074] Based on the above biologi...

Embodiment 3

[0078] Formulation of orodispersible tablets containing mirtazapine by wet granulation

[0079] Table 4: Composition

[0080] Element

mg / tablet

1

Mirtazapine

45

2

Heavy Magnesium Carbonate

181.6

3

sodium saccharin

4

4

Silicified Microcrystalline Cellulose (Prosolv SMCC-90)

43.5

5

Mannitol

65.25

6

Polyvinylpyrrolidone

9

7

Polyvinylpolypyrrolidone (Polyplasdone XL-10)

26.1

8

pure water

Appropriate amount

[0081] 9

Silicified Microcrystalline Cellulose (Prosolv SMCC-90)

21.75

10

Blackcurrant Essence Silarom

8.7

11

Polyvinylpolypyrrolidone (Polyplasdone XL-10)

26.1

12

Non-Bovine Magnesium Stearate

4

435mg

[0082] Mix ingredients 1-7, mirtazapine, heavy magnesium carbonate, sodium saccharin, Prosolv SMCC-90, man...

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Abstract

A rapidly disintegrating dosage form containing magnesium carbonate heavy is described, which disintegrates upon contact with moisture. The dosage forms can be either dispersible or orodispersible tablets and can accommodate widely different active principles. The magnesium carbonate heavy is found to be an excellent dispersant under basic and neutral conditions, and gives the tablets a smooth mouth-feel.

Description

field of invention [0001] The present invention relates to compositions in solid pharmaceutical dosage form that disperse rapidly on exposure to moisture. Background technique [0002] For those patients who have difficulty swallowing and need to take large doses of active ingredients to achieve therapeutic effects, especially when it is difficult to prepare tablets of suitable size that are easy to swallow, dosage forms that disintegrate quickly before swallowing can facilitate the administration of drugs for patients. [0003] Two dosage forms, dispersible tablet and orodispersible tablet, can solve the above problems. Dispersible tablets disintegrate in water before ingestion while orodispersible tablets disintegrate on contact with the water lining the mouth lining. These two dosage forms offer significant advantages over traditional tablets that need to be swallowed. By dissolving the tablet in water first, a large amount of medicine can be taken by the patient, who w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20
CPCA61K9/2027A61K9/205A61K9/2054A61K9/0056A61K9/2018A61K9/2009A61P43/00
Inventor 托尔维·E·克里斯蒂安松
Owner ACTAVIS GRP PTC EHF
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