Nasal in situ gel delivery system, preparation and applications thereof

A technology of in-situ gel and drug delivery system, which was applied in the field of application in 2004, can solve the problems that there are no research reports on NGF in-situ gel preparations, and achieve quality control, good biocompatibility, and stable performance. Effect

Active Publication Date: 2015-10-28
PEKING UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to literature search, there is currently no research report on NGF in situ gel preparation

Method used

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  • Nasal in situ gel delivery system, preparation and applications thereof
  • Nasal in situ gel delivery system, preparation and applications thereof
  • Nasal in situ gel delivery system, preparation and applications thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Example 1 Prescription Optimization of Nasal In Situ Gel Delivery System

[0029] The present invention selects 31°C, which is lower than the physiological temperature of the nasal cavity and higher than the indoor temperature, as the in-situ gel screening index to optimize the preparation process and prescription of the nasal in-situ gel preparation.

[0030] In the experiment, it was found that when poloxamer P407 was used alone, its phase transition temperature (Tsol-gel) from solution to gel increased with the decrease of P407 concentration ( figure 1 shown), and the concentration had a significant effect on Tsol-gel. For example, if the concentration of P407 solution is reduced from 16% to 15%, Tsol-gel will increase from 29.2°C to 36.9°C, and a 1% difference in P407 concentration will bring about a phase change temperature difference of nearly 8°C for Tsol-gel. Moreover, after it forms a gel, its strength is low and it is easily deformed. This characteristic of ...

Embodiment 2

[0037] The preparation process and prescription of embodiment 2NGF nasal in situ gel preparation

[0038] The process for preparing the NGF nasal in situ gel preparation is a two-bottle method. One of the bottles is the nasal in situ gel solution described in Example 1, and the other bottle is the NGF freeze-dried powder preparation. Add the gel solution to the NGF freeze-dried powder before use, and mix well. NGF lyophilized powder contains NGF drug, mannitol and albumin. The dosage of NGF is 0.05%-0.1%, the dosage of albumin is 0.1%-0.2%, and the dosage of mannitol is 5%.

Embodiment 3

[0039] Example 3 Quality Evaluation of Nasal In Situ Gel Spray

[0040] According to the spray quality evaluation method described in the 2010 edition of the Chinese Pharmacopoeia, the spray volume of the nasal in situ gel drug delivery system in Example 1 was investigated. The investigation temperatures were 5°C, 20°C, 25°C, 30°C and 35°C, respectively. The research results showed that the amount per spray of the in-situ gel preparation tended to decrease with the increase of the use temperature, but the relative deviation between the amount per spray and the marked amount did not exceed 20%, which met the quality requirements of the Pharmacopoeia for sprays. Even if the storage temperature reaches 35°C, which is already higher than the gelation temperature of the preparation, the preparation exists in a gel state in the spray bottle, but the gel can be sprayed out due to the high shear stress generated during the pressing process, and every time The spray volume also meets ...

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PUM

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Abstract

The present invention belongs to the field of pharmaceutical formulations in medicine, and discloses a nasal in situ gel delivery system, preparation and applications thereof, wherein particularly the system has great advantages in the fields of central nervous system drugs and protein peptide drugs. According to the present invention, the process for preparing the NGF nasal in situ gel preparation is a two-bottle method, wherein one bottle is an in situ gel solution, wherein poloxamer is preferably poloxamer P407 and the content is 16-16.8%, the polyethylene glycol is preferably PEG10000 and the content is 0.2-0.6%, the polysorbate is preferably Tween80 and the content is 1-3%, the preservative is preferably benzalkonium chloride and the content is 0.001-0.002%, the other bottle is NGF lyophilized powder preparation, the NGF content is 0.05-0.1%, the albumin content is 0.1-0.2%, the mannitol content is 5%, and before the use, the gel solution is added to the NGF lyophilized powder and uniform mixing is performed so as to obtain the system. According to the present invention, the disclosed drug delivery system can be used in any nasal administration dosage forms, preferably nasal drops and sprays; and with the nasal in situ gel delivery system, the difficult problem that the protein peptide drugs are used for the central nervous system is solved, and especially the application range for the nerve growth factor is expanded.

Description

[0001] Technical field The present invention relates to the preparation method and prescription of nasal in situ gel drug delivery system, and its characteristics, including nasal spray stability, drug retention in nasal cavity, drug sustained release, cilia toxicity, and protein polypeptide drugs For example, the application of albumin and nerve growth factor (NGF) belongs to the research field of pharmaceutical drug delivery system. Background technique [0002] Anatomical studies have proved that there are olfactory epithelial pathways and olfactory nerve pathways between the nasal cavity and the cranial cavity, which provide a way for macromolecular drugs to enter the brain directly through the nasal cavity [1]. Experiments have proved that those drugs that are located in the central nervous system and whose efficacy is related to brain function, such as drugs for Parkinson's, Alzheimer's disease or pain, especially drugs with extremely low concentrations in the brain under...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/34A61K38/18A61K47/42
Inventor 谢英徐海峰王军波叶天健卢敏丁源刘畅孙丹杨鸿鸽陈勇灵蔡犇
Owner PEKING UNIV
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