Cannabidiol self-nanoemulsion buccal membrane preparation as well as preparation method and application thereof

A self-nano and self-nanoemulsion technology of cannabidiol, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulations, emulsion delivery, etc., can solve the problems of low bioavailability and unimproved dissolution rate of cannabidiol, reaching High bioavailability, reduced loss and swallowing, enhanced absorption effect

Active Publication Date: 2021-08-06
NEOFORM BIOPHARMACEUTICAL LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since CBD is still dispersed in the film in solid form, the dissolution rate of cannabidiol in th

Method used

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  • Cannabidiol self-nanoemulsion buccal membrane preparation as well as preparation method and application thereof
  • Cannabidiol self-nanoemulsion buccal membrane preparation as well as preparation method and application thereof
  • Cannabidiol self-nanoemulsion buccal membrane preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 instrument / equipment and detection method

[0057] 1. Instruments and equipment

[0058] High-performance liquid chromatography (Agilent Agilent, 1260Infinity II), particle size potentiometer (Malvern Malvern, Nano ZS90), transdermal diffusion tester (Shanghai Kaikai Technology Trading Co., Ltd., TK-12D).

[0059] 2. Detection method

[0060] (1) Establishment of cannabidiol analysis method: high performance liquid chromatography

[0061] Instrument: Agilent 1260 Infinity II high performance liquid chromatography was used to separate, analyze and quantify cannabidiol and its preparations.

[0062] condition:

[0063] Chromatographic column: Inertsil ODS-3 5μm 4.6*50mm (UP);

[0064] Mobile phase: A water; B methanol; A:B=22:78v / v;

[0065] Flow rate: 1.0mL / min; Wavelength: 210nm; Injection volume: 20μL.

[0066] (2) Determination of the particle size of the emulsion droplet in the self-nanometer emulsion process and the particle size of the composite ...

Embodiment 2

[0079] Embodiment 2 Cannabidiol self-preparation of nanoemulsion

[0080] 1. Screening of oil phase, surfactant and co-surfactant:

[0081] Determination of the solubility of cannabidiol in different oils, surfactants and co-surfactants: the selected oils, surfactants and co-surfactants were placed in 2mL glass bottles, and excess cannabidiol was added, Sonicate for 2 hours, and keep stirring (100 rpm) in a shaking incubator (37°C) for 72 hours after sealing. After centrifugation (3500rpm, 20min), take the supernatant and filter it with a nylon filter (0.45μm), dilute it with a certain amount of methanol, and use HPLC to measure the saturation solubility of cannabidiol in different oils, surfactants and co-surfactants. The raw material drug of cannabidiol was used as the reference drug. The oils, surfactants and co-surfactants screened included but were not limited to caprylic capric mono-diglycerides, polyoxyethylene (35) castor oil, diethylene glycol monoethyl ether, mediu...

Embodiment 3

[0089] Embodiment 3 Preparation of single-layer buccal adhesion film and double-layer buccal adhesion film (blank film without cannabidiol)

[0090] Preparation of monolayer buccal adhesive membrane:

[0091] Hypromellose (HPMC K4M, HPMC K15M, HPMC K100M, HPMC E4M, HPMC E100M), carbomer (971P, 934P), polycarbophil, sodium alginate, sodium carboxymethylcellulose (CMC -Na 8000, CMC-Na 12000), polyvinylpyrrolidone (PVP K30, PVP K60, PVP K90), etc. were prepared into a single film-forming solution with a mass fraction of 0.5-5%. According to the designed prescription (refer to the formula of cannabidiol self-nano-emulsion oral and buccal film preparation 1-16, just take the film-forming material components listed above, and do not take the ones that are not listed, and mix them according to the content in the formula. The plasticizer is also taken according to the same standard), mix the film-forming materials with different prescription quantities and add the plasticizer (glycer...

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Abstract

The invention discloses a cannabidiol self-nanoemulsion buccal membrane preparation as well as a preparation method and application thereof. The bioadhesive membrane comprises a backing membrane and a bioadhesive membrane layer adhered to the backing membrane, wherein the bioadhesive film layer is formed by dispersing cannabidiol in a self-nanoemulsion system, adsorbing the cannabidiol by a solid carrier and then dispersing the cannabidiol in a film-forming polymer, and the self-nanoemulsion system comprises an oil phase, a surfactant and a cosurfactant. According to the cannabidiol self-nanoemulsion buccal membrane preparation disclosed by the invention, the cannabidiol is in a supersaturated dissolved state in an oil phase, the solubility of the cannabidiol in a system is improved, nano-scale liquid drops formed by the self-nanoemulsion promote permeation and absorption of the cannabidiol in buccal mucosa, the taking effect time of a medicine is shortened, and the bioavailability of the medicine is improved. The cannabidiol self-nanoemulsion buccal membrane preparation disclosed by the invention can be applied to the aspects of resisting epilepsy, easing pain, treating mental diseases (such as schizophrenia, division affective disorder and delusional disorder), resisting anxiety, resisting depression and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention relates to a cannabidiol self-nanoemulsion oral buccal membrane bilayer preparation and its preparation method and application. Background technique [0002] Cannabidiol (CBD) is the main chemical component in the medicinal plant cannabis. Different from addictive tetrahydrocannabinol (THC), CBD not only has no neurotoxicity, but also hinders the influence of THC on the human nervous system, and has various pharmacological effects on the nervous system. Inflammation, pain, anxiety and other mental diseases have great clinical application value. A large number of studies have shown that CBD has obvious anti-epileptic and anti-convulsant activities, and has fewer side effects than existing anti-epileptic drugs. [0003] In 2018, Epidiolex became the world's first and only CBD drug approved by the FDA for the treatment of seizures associated with Lennox-Gastau...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K9/107A61K47/32A61K47/10A61K47/38A61K47/14A61K47/44A61K31/05A61P25/08A61P29/00A61P25/00A61P25/18A61P25/22A61P25/24
CPCA61K9/006A61K9/1075A61K47/32A61K47/10A61K47/38A61K47/14A61K47/44A61K31/05A61P25/08A61P29/00A61P25/00A61P25/18A61P25/22A61P25/24A61K9/7007
Inventor 田芳刘孟温益峰
Owner NEOFORM BIOPHARMACEUTICAL LTD
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