Tolterodine tartrate tablet and preparation process thereof
A technology of tolterol tartrate and tartaric acid, applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, inorganic non-active ingredients, etc., can solve the problem of being easily affected by wet and hot environments, and the content of finished products is not high. Uniformity, complex preparation process and other issues, to achieve the effect of ensuring drug safety, improving dissolution rate, and simple preparation process
Pending Publication Date: 2022-06-24
LUNAN PHARMA GROUP CORPORATION
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Problems solved by technology
The particle size of the raw material is not controlled in the process of the invention, which may easily lead to uneven content of the finished product, and large differences in dissolution in different media in vitro
[0008] In the existing tolterodine tartrate formulations, the main preparation process of tablets is mainly wet granulation, which needs to be dried at high temperature in a fluidized bed, and the product is easily affected by the wet and hot environment during the preparation process. It is conducive to the stability of product quality, and the preparation process is relatively complicated, and the production is time-consuming and laborious, which is not conducive to industrial large-scale production
Method used
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Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0031] Tablet core prescription (1000 tablets)
[0032]
[0033]
[0034] Film Coating Formulation:
[0035]
[0036] Preparation process: The raw material of tolterodine tartrate is micronized, and the particle size is controlled at D 90 ≤120μm; take tolterodine tartrate, microcrystalline cellulose 101, lactose 200M, hypromellose, low-substituted hypromellose, magnesium stearate, and silicon dioxide and mix them uniformly by an equal amount incremental addition method; The powder is granulated by a dry granulation machine; the mixed granules are added with additional magnesium stearate and mixed evenly, and then pressed into tablets; the coating machine performs film coating. 0.1-0.2Mpa, the coating weight gain is controlled by 2% to 5%.
Embodiment 2
[0038] Tablet core prescription (1000 tablets)
[0039]
[0040] Film Coating Formulation:
[0041]
[0042] Preparation process: Refer to Example 1 for the preparation process.
Embodiment 3
[0044] Tablet core prescription (1000 tablets)
[0045]
[0046] Film Coating Formulation:
[0047]
[0048] Preparation process: preparation process reference example 1
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Abstract
The invention belongs to the technical field of pharmaceutical preparations, and provides a pharmaceutical composition containing an active ingredient tolterodine tartrate and a preparation process of the pharmaceutical composition. The tolterodine tartrate tablet is obtained by controlling the particle size (D90 is less than or equal to 120 microns) of active ingredients, optimizing preparation auxiliary materials and dosage thereof and optimizing a coating material, uniformly mixing with the auxiliary materials, performing dry granulation, tabletting and coating with a film. Compared with an existing preparation, the dissolution speed of the tolterodine tartrate pharmaceutical composition is increased; and an acceleration test shows that the quality is stable, the medication safety is ensured, and the preparation method is suitable for industrial production.
Description
technical field [0001] The invention belongs to the technical field of pharmaceutical preparations and provides tolterodine tartrate tablets and a preparation process thereof. Background technique [0002] Tolterodine tartrate, a competitive and selective muscarinic receptor antagonist, is suitable for the treatment of symptoms of urinary frequency, urgency and incontinence caused by overexcited bladder. Developed by Pharmacia & Upjohn Co, it was launched in the United States in 1998. This product is white crystalline powder, odorless and bitter in taste. The pKa value is 9.87, the solubility in water is 12 mg / mL, it is soluble in methanol, slightly soluble in ethanol, and almost insoluble in toluene. The chemical name of tolterodine tartrate is: (R)-N,N-diisopropyl-3-(2-hydroxy-5-methylphenyl)-3-phenylpropylamine L(+)-tartrate, The structure is as follows: [0003] [0004] Tolterodine tartrate tablets have the characteristics of small preparation specifications, les...
Claims
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IPC IPC(8): A61K9/36A61K47/38A61K47/02A61K31/137A61P13/00A61P13/10
CPCA61K9/2866A61K9/2813A61K9/2054A61K31/137A61P13/00A61P13/10
Inventor 张贵民宋丽莉张磊朱茂庆
Owner LUNAN PHARMA GROUP CORPORATION