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Carrier particle with porous structure and its preparation method and application

A technology of carrier particles and porous structure, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. Accuracy and other issues, to achieve the effect of improving atomization and transfer performance, simple operation, and good controllability of parameters

Active Publication Date: 2019-09-20
GUANGZHOU ZHONGDA NANSHA TECH INNOVATION IND PARK +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For DPIs, the amount of the main drug contained in it is generally low, so the pure drug (carrier-free) DPIs often produce inaccurate dosages during the preparation process
Moreover, because the drug particles in DPIs are small and the surface energy is huge, they are prone to aggregation, which affects the stability and uniformity of the preparation.

Method used

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  • Carrier particle with porous structure and its preparation method and application
  • Carrier particle with porous structure and its preparation method and application
  • Carrier particle with porous structure and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Dissolve mannitol and ammonium carbonate in different mass ratios (1:1, 2:1, 3:1, 4:1, 5:1, 7:1) or separate mannitol in water, and prepare a concentration of 25mg respectively / ml (the total concentration of mannitol and ammonium carbonate), and then adopt a spray dryer to spray dry the above solution to prepare carrier particles. The conditions of spray drying are as follows: the inlet air temperature is 130°C, and the outlet air temperature is 75°C. The liquid rate is 10ml / min, the nozzle diameter is 0.71mm, the atomization pressure is 90Kpa, and the air flow rate is 0.60m 3 / h. The mannitol carrier particles obtained under these conditions were evaluated or characterized as follows.

[0057] (1) Density measurement, the specific method is: take an appropriate amount of carrier mg and place it in a 1ml precision syringe, and record the initial volume V of the carrier. 0 , then the bulk density of the carrier is ρ b =m / V 0 ;Tap the syringe until the volume of the ...

Embodiment 2

[0069] Dissolve small molecule sugar alcohols (lactose, mannitol or trehalose) and ammonium carbonate in water at a mass ratio of 3:1, and prepare solutions with a concentration of 25 mg / ml (the total concentration of small molecule sugar alcohols and ammonium carbonate) , and then use a spray dryer to spray-dry the above solution to prepare porous carrier particles. The spray-drying conditions are as follows: the inlet air temperature is 130°C, the outlet air temperature is 75°C, the pump liquid rate is 10ml / min, and the nozzle diameter is 0.71mm, atomization pressure is 90Kpa, air flow is 0.60m 3 / h.

[0070]Mix the spray-dried porous carrier particles with micronized ciprofloxacin hydrochloride drug particles and budesonide drug particles at a mass ratio of 30:1, and pack them into No. 3 capsules (10±0.5mg / capsule) , that is, ciprofloxacin hydrochloride dry powder inhaler or budesonide dry powder inhaler, and a new generation of pharmaceutical impactor (NGI) was used to ev...

Embodiment 3

[0079] Dissolve mannitol and porogen (ammonium carbonate or ammonium bicarbonate) in water at a mass ratio of 3:1, and prepare solutions with a concentration of 25 mg / ml (the total concentration of mannitol and porogen) respectively, and then use a spray dryer to The above solution is spray-dried to prepare carrier particles with a porous structure. The spray-drying conditions are as follows: the inlet air temperature is 130°C, the outlet air temperature is 75°C, the pump liquid rate is 10ml / min, the nozzle diameter is 0.71mm, and the atomization pressure 90Kpa, airflow 0.60m 3 / h. See Table 4 for the median diameter, bulk density and bulk density of the carrier particles with porous structure after spray drying. The results show that: the carrier particles with porous structure prepared by using ammonium carbonate as thermal decomposition type porogen have little difference between the median particle diameter and the median particle diameter when ammonium bicarbonate is use...

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Abstract

The invention relates to porous-structure carrier particles as well as a preparation method and application thereof. The porous-structure carrier particles are prepared from small-molecule sugar alcohol, a pore forming agent and a solvent, wherein the mass ratio of the small-molecule sugar alcohol to the pore forming agent is (1:9)-(9:1); the small-molecule sugar alcohol is at least one of trehalose, mannitol, lactose, galactose, xylitol and glucose; and the pore forming agent is at least one of ammonium carbonate and ammonium hydrogen carbonate. Without residues of additives and organic solvents, the porous-structure carrier particles have the characteristics of low density and large specific surface area, and can effectively improve the atomization and transfer performance of a dry powder inhaler as a dry powder inhaler carrier so as to effectively increase the drug effective deposition rate of the dry powder inhaler. The preparation method provided by the invention can be used for preparing the porous-structure carrier particles in one step, is simple to operate, has good parameter controllability and is suitable for industrial batch production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a carrier particle with a porous structure and a preparation method and application thereof. Background technique [0002] With the continuous deepening of human research on the structure, function, physiological characteristics and diseases of the lung, the pulmonary drug delivery system (PDDS) has gradually become a popular new drug delivery system. PDDS is to effectively deliver drugs to the lungs, and make them directly act on the delivery site or be absorbed into the blood at the delivery site, so as to achieve the purpose of preventing, treating or diagnosing diseases. PDDS has the following advantages: (1) administration without gastrointestinal irritation and enzymolysis; (2) avoiding the first-pass effect of the liver, and low local enzyme activity, especially suitable for protein and polypeptide drugs; (3) alveolar absorption surface area Large, rap...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/02A61K47/26A61K9/72A61K31/496A61K31/58A61P11/00A61P11/06
Inventor 吴传斌张雪娟赵紫玉潘昕黄莹彭婷婷
Owner GUANGZHOU ZHONGDA NANSHA TECH INNOVATION IND PARK
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