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Fluoxetine medicinal preparation

A drug and tablet technology, which is applied to the field of pharmaceutical preparations containing fluoxetine hydrochloride and dispersible tablets, can solve the problems of reduced curative effect, inability to complete the treatment, and no unpleasantness in the special sensory characteristics of patients, and achieves simple preparation. Effect

Inactive Publication Date: 2003-09-10
LILLY SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As already noted, these problems can lead to incomplete treatment, which greatly reduces efficacy
Therefore, generally speaking, the existing dosage forms of fluoxetine hydrochloride cannot fully meet some requirements required for the treatment of depression and other related diseases, for example, it should be applicable to any patient, and it cannot be specific to the patient's special sensory characteristics. any unpleasant phenomenon

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Dispersible tablets are prepared from the following pharmaceutical formulations:

[0055] components Weight (mg) Weight %

[0056] Fluoxetine hydrochloride 20 6.7

[0057] Sodium starch glycolate 50 16.66

[0058] Lactose 123 40.97

[0059] L-HPC21 75 25.00

[0060] Sodium saccharin 2 0.67

[0061] Mint Spice 30 10.00

[0062] The preparation method is to weigh all the raw materials separately first, and then sieve them with a 1.19mm mesh sieve as a safety measure. After sieving, the excipients are placed in a suitable mixer, the active ingredients are added and mixed until homogeneous.

[0063] After mixing, the powder is sieved several times with a 0.5 mm mesh sieve. Then press the tablet, carry out regular quality control during the preparation process and pay attention to the results on the control card. The powder flowed satisfactorily and compacted without difficulty. Finally, a representative sample is analyzed statistically (from ...

Embodiment 2

[0072] Dispersible tablets are prepared from the following pharmaceutical formulations:

[0073] components Weight (mg) Weight%

[0074] Fluoxetine hydrochloride 20 4.02

[0075] Sodium starch glycolate 50 10.00

[0076] Pregelatinized starch 337 67.38

[0077] L-HPC21 25 5.00

[0078] Sodium saccharin 3 0.60

[0079] Mint Spice 50 10.00

[0080] Titanium dioxide 15 3.00

[0081] The preparation method of Example 1 was used except that the mixture powder was sieved through a 0.8mm (instead of 0.5mm) mesh sieve. The powder flowed satisfactorily and compacted without difficulty.

[0082] The obtained dispersible tablet has the following characteristics: Weight per tablet: 500mg±5% 10 tablets Weight: 5g±3% Hardness: 5.5kgf Thickness: about 3.6mm Diameter: 12.25mm Disintegration in 19°C-21°C water: <3 minute

Embodiment 3

[0083] Example 3 Dispersible tablets were prepared from the following pharmaceutical formulations: components Weight (mg) Weight % Fluoxetine Hydrochloride 20.1 4.47 Sodium Starch Glycolate 45.0 10.00 CMC*, AVICEL PH101 162.7 36.155 Dry Stream Starch 162.7 36.155 L-HPC21 22.5 5.00 Sodium Saccharin 3.00 0.67 Peppermint Flavor Rich 10.00 2.22 Titanium Dioxide 33.30 Stearoyl Dioxide 15.00 Sodium maleate 4.5 1.00 Colloidal silicon dioxide 4.5 1.00 *CMC: microcrystalline cellulose The method of Example 2 was used. The powder flowed satisfactorily and pressed without difficulty. The prepared dispersible tablet has the following characteristics: Weight per tablet: 450mg±5% 10 tablets Weight: 4.5g±3% Hardness: 7kgf Thickness: about 3.3mm Diameter: 12.25mm Disintegrate in water at 19°C-21°C: <3 minutes

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Abstract

Pharmaceutical formulations of fluoxetine or an acid addition salt thereof, suitable for manufacturing dispersible tablets by direct compression and comprising, in addition to the active ingredient, the appropriate excipients and coadjuvants, selected from among disintegrants, diluents, lubricants, anti-adherents, sweeteners, flavorings and, optionally, colorants. Said formulations are suitable for manufacturing dispersible tablets which disintegrate in less than three minutes in water at 19 DEG C - 21 DEG C, and are appropriate for treatment of depression.

Description

[0001] This application is a divisional application of the Chinese patent application whose Chinese patent application number is 95115241.6, the application date is July 20, 1995, and the invention title is "fluoxetine pharmaceutical preparation). technical field [0002] The invention relates to a pharmaceutical preparation containing fluoxetine hydrochloride (fluoxetine): suitable for the production of a solid oral dosage form. Particularly, the present invention relates to a pharmaceutical preparation containing fluoxetine hydrochloride, a dispersible tablet, and a preparation method thereof. Background technique [0003] Fluoxetine, i.e. N-methyl-3-(P-trifluoromethylphenoxy)-3-amphetamine, is an antidepressant, see for example German patent DE2500110 and US patent US4314081 (Eli Lilly & Co.) stated. The antidepressant effects of fluoxetine appear to be based on its ability to selectively inhibit the uptake of serotonin by central nervous system neurons. Fluoxetine is p...

Claims

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Application Information

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IPC IPC(8): A61J3/10A61K9/00A61K9/20A61K31/135A61K31/137A61K31/138A61K47/30A61K47/36A61K47/38A61P25/24A61P25/26
CPCA61K31/138A61K9/2027A61K9/0095A61K9/2095A61K9/0056A61K9/2059A61K9/2018A61K9/2054A61P25/24A61P25/26A61K47/36A61K31/135A61K9/28
Inventor F·阿斯门迪扎巴尔
Owner LILLY SA
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