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Tolvaptan soft capsule preparation and preparation process thereof

A soft capsule preparation, the technology of tolvaptan, is applied in the directions of capsule delivery, medical preparations of inactive ingredients, cardiovascular system diseases, etc., to achieve the effects of improving the cumulative dissolution rate, good product appearance quality, and optimized selection.

Inactive Publication Date: 2018-04-13
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

What deserves special attention is that no orthostatic hypotension has been reported after using this product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Tolvaptan soft capsule content prescription:

[0060] Tolvaptan raw material 0.05g; Caprylic capric macrogol glyceride 220g;

[0061] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0062] 0.035 g of 2,6-di-tert-butyl-p-cresol.

[0063] Softgel prescription:

[0064] Gelatin 160mg; Glycerin 80mg;

[0065] Yellow iron oxide 0.29mg; titanium dioxide 2mg.

[0066] Preparation:

[0067] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of tolvaptan raw material after heating up to 40°C drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1h until uniform, and then cool down to room temperature to obtain the content;

[0068] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yellow iron oxide passed throug...

Embodiment 2

[0071] Tolvaptan soft capsule content prescription:

[0072] Tolvaptan raw material 0.01g; Caprylic capric macrogol glyceride 225g;

[0073] Polyglycerol oleate 50g; medium chain triglyceride 72g;

[0074] 0.038g of 2,6-di-tert-butyl-p-cresol.

[0075] Softgel prescription:

[0076] Gelatin 160mg; Glycerin 80mg;

[0077] Yellow iron oxide 0.25mg; titanium dioxide 2.2mg.

[0078] Preparation:

[0079] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of tolvaptan raw material after heating up to 40°C drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1h until uniform, and then cool down to room temperature to obtain the content;

[0080] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yellow iron oxide passed through...

Embodiment 3

[0083] Tolvaptan soft capsule content prescription:

[0084] Tolvaptan raw material 0.02g; Caprylic capric macrogol glyceride 220g;

[0085] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0086] Softgel prescription:

[0087] Gelatin 161mg; Glycerin 85mg;

[0088] Yellow iron oxide 0.27mg; titanium dioxide 2mg.

[0089] Preparation:

[0090] (1) Prepare the contents: take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of tolvaptan raw material after heating up to 40°C Continue to stir the medicine for 1 hour until it is uniform and then cool down to room temperature to obtain the content;

[0091] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yellow iron oxide passed through an 80-mesh sieve and mix evenly, then add gelatin and heat up ...

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PUM

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Abstract

The invention discloses a tolvaptan soft capsule preparation. The tolvaptan soft capsule preparation comprises a soft capsule and a content, wherein the content comprises 0.01-0.1 g of a tolvaptan rawmaterial, 200-250 g of glycerides, 30-60 g of polyglycerol oleate, 50-100 g of median chain triglyceride oil and 0.02-0.05 g of 2,6-di-tert-butyl-methylphenol. According to the tolvaptan soft capsulepreparation, the cumulative dissolution rate after 5 min of dissolution can be remarkably increased, and the dissolution efficiency of a main drug in the anterior time period is improved. The tolvaptan soft capsule preparation is favorable in stability and product appearance quality.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a tolvaptan soft capsule preparation and a preparation process thereof. Background technique [0002] Tolvaptan is a selective β-blocker with vasodilator effect, mainly used in the treatment of essential hypertension and chronic heart failure. It has the advantages of significant curative effect, convenient medication, and less adverse reactions. It is a new promising antihypertensive drug. It was approved for marketing in Germany for the first time in 1997 for the treatment of essential hypertension. Because tolvaptan has the advantages of both heart protection and vasodilation, it is predicted to be one of the "ten blockbusters" with good market prospects in the future. [0003] Features of this product: [0004] (1) Tolvaptan lacks endogenous reverse sympathetic and membrane stabilizing effects, but it can exert its vasodilation effect by releasing nitric...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/55A61K47/14A61K47/42A61K47/10A61K47/02A61P9/04A61P9/12
CPCA61K9/4808A61K9/4825A61K9/4858A61K9/4866A61K31/55
Inventor 王雪峰
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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