CN111228241B - Film forming composition and application thereof - Google Patents
Film forming composition and application thereof Download PDFInfo
- Publication number
- CN111228241B CN111228241B CN202010056963.9A CN202010056963A CN111228241B CN 111228241 B CN111228241 B CN 111228241B CN 202010056963 A CN202010056963 A CN 202010056963A CN 111228241 B CN111228241 B CN 111228241B
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- film
- forming composition
- agent
- oil
- film forming
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- 239000003906 humectant Substances 0.000 claims abstract description 24
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- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to a film forming composition and application thereof, in particular to the film forming composition which comprises cannabis diphenol oil, and auxiliary materials such as an emulsifying agent, a film forming agent, a plasticizer, a humectant and the like. The film prepared from the film forming composition disclosed by the invention can be dissolved in water, is not sticky and is resistant to traction, is not easy to wrinkle and break in the film preparation process, and is high in product quality and yield.
Description
Technical Field
The invention belongs to the field of film forming, and particularly relates to a film forming composition containing hemp oil-like extract and application thereof.
Background
Cannabis (Cannabis sativa l.), also known as Cannabis or Cannabis sativa, is a plant of the genus Cannabis in the family Moraceae. The cannabidiol component contained in cannabis is a phenolic compound which is not separated from other animals and plants at present. Cannabidiol is a non-addictive ingredient and has high medicinal value. Researches show that if cannabidiol is reasonably applied to medicine, the cannabidiol has the functions of resisting epilepsy, psychosis, depression and pain, relieving nausea caused by chemotherapy of cancer, treating asthma and the like. Cannabidiol is also a powerful antioxidant, has the adverse effect of blocking human nerves of certain drugs, and has a series of physiological activity functions of blocking breast cancer metastasis, resisting rheumatoid arthritis, resisting insomnia and the like.
Due to the medicinal value of cannabidiol, more and more cannabidiol formulations have been developed. However, existing cannabidiol formulations suffer from a number of drawbacks, for example, oral administration of cannabidiol does not always provide a rapid onset of action. There are also some pediatric and/or geriatric patients who have difficulty taking oral formulations due to inability to swallow, nausea or other gastrointestinal problems. In addition, films or wafers that typically contain cannabis extracts are very viscous, have a bitter aftertaste, and can lead to patient non-compliance; and conventional films or wafers often cannot include highly loaded active ingredients.
Therefore, how to obtain a preparation which takes cannabidiol as an active ingredient and has accurate unit dosage form content and convenient use is an important research direction in the field.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a film forming composition containing cannabidiol oil, which is used for preparing a film agent with non-sticky property, accurate unit dosage form content, convenient use and less loss in the production process.
In a first aspect, the present invention provides a film-forming composition comprising an active ingredient and an adjuvant; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifying agent, a film forming agent, a plasticizer, a humectant, a flavoring agent, a salivation promoter and an oil phase.
In a preferred embodiment, the emulsifier is selected from the group consisting of: cyclodextrin, phospholipids, phosphatidylcholine, polyethylene glycol, tocopheryl polyethylene glycol succinate, cremophor, lutrol, poloxamers, cholesterol, octyldodecanol, polyglyceryl oxide, labrasol, labrafil, pluronics, polysorbate, ethyl linoleate, monoglyceride, diglyceride, triglyceride, sodium bis (2-ethylhexyl) sulfosuccinate, sodium monomethylnaphthalene sulfonate, sodium dimethylnaphthalene sulfonate, tocopheryl acetate, solutol, soybean oil, capmuls, sodium lauryl sulfate, sorbitol esters, sorbitan, stearic acid, tween, bile salts, fatty acids, and combinations thereof.
In a preferred embodiment, the film former is selected from the group consisting of: pullulan, polydextrose, chitosan, starch, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, xanthan gum, tragacanth gum, acacia gum, guar gum, pectin, gelatin, carrageenan, locust bean gum, dextran, gellan gum, alginate, polyvinylpyrrolidone, polyethylene oxide, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methyl methacrylate copolymers, carboxyvinyl copolymers, ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, calcium phosphate, talc, calcium silicate, calcium carbonate, and combinations thereof.
In a preferred embodiment, the plasticizer is selected from the group consisting of: propylene glycol, ethylene glycol, glycerin, triacetin, triacetyl citrate, polypropylene glycol, polyethylene glycol, mineral oil, and combinations thereof.
In a preferred embodiment, the humectant is selected from the group consisting of: guar gum, sorbitol, glycerin, propylene glycol, polyethylene glycol, and combinations thereof.
In a preferred embodiment, the flavoring agent is selected from the group consisting of: sucralose, sucrose, glucose, sodium saccharin, fructose, xylitol, stevioside, acesulfame potassium, maltose, mannitol, saccharin, citric acid, licorice, fruit juice, aspartame, honey, and combinations thereof; or the flavoring agent is an organic oil from one or more of the following plants: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry, blueberry.
In a preferred embodiment, the oil phase is selected from the group consisting of: jojoba oil, white oil, olive oil, and combinations thereof.
In a preferred embodiment, the film-forming composition further comprises an antifoaming agent.
The second aspect of the invention provides a film forming system, which consists of an active ingredient, auxiliary materials and water; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifying agent, a film forming agent, a plasticizer, a humectant, a flavoring agent, a salivation promoter and an oil phase.
In a third aspect the present invention provides the use of a film-forming composition according to the first aspect for the preparation of an oral or external preparation.
In a fourth aspect the present invention provides the use of a film-forming composition according to the first aspect for the preparation of a medicament, food or health product.
It is understood that within the scope of the present invention, the above-described technical features of the present invention and technical features specifically described below (e.g., in the examples) may be combined with each other to constitute new or preferred technical solutions. And are limited to a space, and are not described in detail herein.
Detailed Description
As used herein, the term "room temperature" means a temperature of 15-30 ℃.
As used herein, the term "filament" is 0.1 millimeters.
As used herein, "about" means within + -10% of the defined range; preferably within + -5%.
Percentages and parts used herein are by weight unless otherwise indicated.
Film-forming compositions of the invention
The film-forming composition of the invention comprises an active ingredient and auxiliary materials for preparing instant film agents.
The active ingredient used in the invention is cannabidiol oil. The cannabidiol oil is an oily extract extracted from cannabis and is an oily mixture containing cannabidiol. It may be extracted from cannabis by the inventors according to known methods or may be commercially available.
In another preferred embodiment, the cannabidiol oil used in the present invention has a Tetrahydrocannabinol (THC) content of less than 0.3% or 0%.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 80% or more.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 85% or more.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 90% or more.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 95% or more.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 98% or less.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 95% or less.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 90% or less.
In another preferred embodiment, the active ingredient is 1.51 to 29.95wt% of the total weight of the film forming composition.
In another preferred embodiment, the active ingredient is 1.51 to 13.38wt% of the total weight of the film forming composition.
In another preferred embodiment, the active ingredient is 2.15 to 29.95wt% of the total weight of the film forming composition.
In another preferred embodiment, the active ingredient is 2.15 to 13.38wt% of the total weight of the film forming composition.
The film agent prepared by the film forming composition can be administrated through an oral cavity, and can quickly dissolve and release active ingredients when contacting saliva. Therefore, the selection of appropriate excipients has a critical effect on the formulation to be prepared. In addition, the adjuvants used in the film-forming composition should have good compatibility with the active ingredient and be nontoxic to the subject.
The film-forming composition of the present invention comprises one or more emulsifiers. The emulsifier has hydrophilic group and lipophilic group, and can form stable emulsion with mixed liquid of two or more kinds of mutually insoluble components. The emulsifier used in the invention can lead the cannabidiol oil as an active ingredient to be well compatible with other ingredients. Emulsifying agents suitable for use in the present invention include, but are not limited to, cyclodextrin (e.g., beta cyclodextrin), phospholipids, phosphatidylcholine (or lecithin), polyethylene glycol, tocopheryl polyethylene glycol succinate, cremophor (e.g., nonionic polyethoxylated detergents), lutrol, poloxamer (e.g., polyethylene-polypropylene glycol), cholesterol, octyldodecanol, polyglyceryl esters, labrasol, labrafil, pluronics, polysorbate, ethyl linoleate, monoglycerides (e.g., capric monoglyceride, caprylic monoglyceride), diglycerides (e.g., capric diglyceride, caprylic diglyceride), triglycerides, bis (2-ethylhexyl) sodium sulfosuccinate, sodium monomethylnaphthalene sulfonate, sodium dimethylnaphthalene sulfonate, tocopheryl acetate, solutol, soybean oil, capmuls, sodium lauryl sulfate (or sodium lauryl sulfate), sorbitol esters, sorbitan, stearic acid, tween (e.g., 20, tween 80), bile salts (e.g., sodium taurate), fatty acids (e.g., oleic acid, linoleic acid), and combinations thereof.
In another preferred example, the polysorbate may be, but is not limited to, polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate), polysorbate 15 60 (polyoxyethylene (20) sorbitan monostearate), polysorbate 80 (polyoxyethylene (20) sorbitan monooleate).
In another preferred embodiment, the emulsifier is selected from the group consisting of: beta cyclodextrin, phospholipids, phosphatidylcholine, poloxamers, cholesterol, octyldodecanol, polyglycerol oxide, labrasol, labrafil, pluronics, polysorbate, ethyl linoleate, capric acid monoglyceride, caprylic acid monoglyceride, capric acid diglyceride, caprylic acid diglyceride, triglycerides, sodium bis (2-ethylhexyl) sulfosuccinate, solutol, soybean oil, capmuls, sodium lauryl sulfate (or sodium lauryl sulfate), sorbitol esters, sorbitan, stearic acid, tween, oleic acid, linoleic acid, and combinations thereof.
In another preferred embodiment, the emulsifier is selected from the group consisting of: beta cyclodextrin, phospholipids, phosphatidylcholine, poloxamers, cholesterol, labrasol, labrafil, pluronics, ethyl linoleate, capric acid monoglyceride, caprylic acid monoglyceride, capric acid diglyceride, caprylic acid diglyceride, triglycerides, solutol, capmuls, sodium lauryl sulfate, tween, and combinations thereof.
In another preferred embodiment, the emulsifier is selected from the group consisting of: beta cyclodextrin, phosphatidylcholine, poloxamer, cholesterol, tween, and combinations thereof.
In another preferred embodiment, the emulsifier is a combination of beta cyclodextrin and phosphatidylcholine.
In another preferred embodiment, the emulsifier is a combination of beta cyclodextrin and poloxamer.
In another preferred embodiment, the emulsifier is a combination of beta cyclodextrin and tween.
In another preferred embodiment, the emulsifier is 7.34 to 32.03wt% of the total weight of the film forming composition.
In another preferred embodiment, the emulsifier is 7.34 to 22.21wt% of the total weight of the film forming composition.
In another preferred embodiment, the emulsifier is 11.15 to 32.03wt% of the total weight of the film-forming composition.
In another preferred embodiment, the emulsifier is 11.15 to 22.21wt% of the total weight of the film forming composition.
In another preferred example, the emulsifier is beta cyclodextrin and phosphatidylcholine; beta cyclodextrin is 3.44 to 18.59wt% (preferably 3.44 to 10.25wt%; or preferably 5.72 to 18.59wt%; or preferably 5.72 to 10.25 wt%) of the total weight of the film-forming composition; the phosphatidylcholine is 3.9 to 13.44wt% (preferably 3.9 to 11.96wt%, or preferably 4.46 to 13.44wt%, or preferably 4.46 to 11.96 wt%) of the total weight of the film-forming composition.
The inventors have screened other emulsifiers and as a result found that different emulsifiers have a large difference in emulsification of cannabidiol oil. The emulsifier screened by the invention can lead cannabis diphenol oil to be better compatible with other components, and the obtained film agent is not sticky, resistant to traction and easy to produce and cut.
The film-forming composition of the present invention further comprises one or more film-forming agents. The film forming agent used in the invention has good compatibility with active ingredients. Film formers suitable for use in the present invention include, but are not limited to, pullulan, polydextrose, chitosan, starch, hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, xanthan gum, tragacanth gum, acacia gum, guar gum, pectin, gelatin, carrageenan, locust bean gum, dextran, gellan gum, alginates (e.g., sodium alginate), polyvinylpyrrolidone, polyethylene oxide, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methyl methacrylate copolymers, carboxyvinyl copolymers, ethylcellulose, hydroxypropyl ethylcellulose, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, calcium phosphate, talc, calcium silicate, calcium carbonate, and combinations thereof.
In another preferred embodiment, the film former is selected from the group consisting of: pullulan, polydextrose, starch, xanthan gum, tragacanth gum, acacia gum, guar gum, pectin, gelatin, carrageenan, locust bean gum, and combinations thereof.
In another preferred embodiment, the film former is selected from the group consisting of: pullulan, starch, xanthan gum, acacia gum, guar gum, pectin, gelatin, and combinations thereof.
In another preferred embodiment, the film forming agent is a combination of pullulan, xanthan gum, and acacia.
In another preferred embodiment, the film former is 20.15 to 73.20wt% of the total weight of the film forming composition.
In another preferred embodiment, the film former is 20.15 to 61.18wt% of the total weight of the film forming composition.
In another preferred embodiment, the film former is 34.85 to 73.20wt% of the total weight of the film forming composition.
In another preferred embodiment, the film former is 34.85 to 61.18wt% of the total weight of the film forming composition.
In another preferred example, the film former is pullulan, xanthan gum, and acacia; pullulan is 19.93 to 72.18wt% (preferably 19.93 to 60.74wt%, or preferably 34.16 to 72.18wt%, or preferably 34.16 to 60.74 wt%) of the total weight of the film-forming composition; xanthan gum is 0.11 to 0.51wt% (preferably 0.11 to 0.34wt%, or preferably 0.17 to 0.51wt%, or preferably 0.17 to 0.34 wt%) based on the total weight of the film-forming composition; gum arabic is present in an amount of 0.11 to 0.51wt% (preferably 0.11 to 0.34wt%; or preferably 0.17 to 0.51wt%, or preferably 0.17 to 0.34 wt%) based on the total weight of the film-forming composition.
The film-forming composition of the present invention further comprises one or more plasticizers. The plasticizers used in the present invention can improve the flexibility and smoothness of the film. Plasticizers suitable for use in the present invention include, but are not limited to, propylene glycol, ethylene glycol, glycerin, triacetin, triacetyl citrate, polypropylene glycol, polyethylene glycol, mineral oil, and combinations thereof.
In another preferred embodiment, the plasticizer is selected from the group consisting of: propylene glycol, ethylene glycol, glycerin, and combinations thereof.
In another preferred embodiment, the plasticizer is propylene glycol.
In another preferred embodiment, the plasticizer is ethylene glycol.
In another preferred embodiment, the plasticizer is glycerol.
In another preferred embodiment, the plasticizer is 7.94 to 28.78wt% of the total weight of the film forming composition.
In another preferred embodiment, the plasticizer is 7.94 to 23.92wt% of the total weight of the film forming composition.
In another preferred embodiment, the plasticizer is 10.04 to 28.78wt% of the total weight of the film forming composition.
In another preferred embodiment, the plasticizer is 10.04 to 23.92wt% of the total weight of the film forming composition.
The film-forming composition of the present invention further comprises one or more humectants. The humectant used in the invention can improve the traction resistance of the film. Humectants suitable for use in the present invention include, but are not limited to, guar gum, sorbitol, glycerin, propylene glycol, polyethylene glycol, and combinations thereof.
In another preferred embodiment, the humectant is guar gum.
In another preferred embodiment, the humectant is sorbitol.
In another preferred embodiment, the humectant is polyethylene glycol.
In another preferred embodiment, the humectant is 0.13 to 0.5wt% of the total weight of the film forming composition.
In another preferred embodiment, the humectant is 0.13 to 0.41wt% of the total weight of the film forming composition.
The inventor screens the dosage of the humectant, and as a result, the inventor finds that if the content of the humectant exceeds 0.5%, the film agent obtained by the film forming system is not resistant to drawing, is easy to stretch and wrinkle when being drawn to form a film, and the produced film has uneven appearance and is not easy to cut, so that the content of the active ingredient of the unit dosage form is inaccurate.
The film-forming compositions of the present invention also comprise one or more flavoring agents. The flavoring agent used in the invention can improve the taste of the film agent and improve the compliance of patients. Flavoring agents suitable for use in the present invention include, but are not limited to, sucralose, sucrose, dextrose, sodium saccharin, fructose, xylitol, stevioside, acesulfame potassium, maltose, mannitol, saccharin, citric acid, licorice, fruit juice, aspartame, honey, and combinations thereof.
In another preferred embodiment, the flavoring agent is an organic oil from one or more of the following group of plants: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry, blueberry.
In another preferred embodiment, the flavoring agent is selected from the group consisting of: sucralose, sucrose, fructose, xylitol, and combinations thereof.
In another preferred embodiment, the flavoring agent is sucralose.
In another preferred embodiment, the flavoring agent is sucrose.
In another preferred embodiment, the flavoring agent is fructose.
In another preferred embodiment, the flavoring agent is 1.16 to 15.03 weight percent of the total weight of the film forming composition.
In another preferred embodiment, the flavoring agent is 1.16 to 5.58wt% of the total weight of the film forming composition.
In another preferred embodiment, the flavoring agent is 3.42 to 15.03 weight percent of the total weight of the film forming composition.
In another preferred embodiment, the flavoring agent is 3.42 to 5.58wt% of the total weight of the film forming composition.
The film-forming composition of the present invention further comprises one or more salivation promoting agents. The salivation accelerator used in the invention can promote salivation of a subject and accelerate dissolution of a film agent in an oral cavity. Salivation promoting agents suitable for use in the present invention include, but are not limited to, peppermint, citric, malic, lactic, tartaric acids, and combinations thereof.
In another preferred embodiment, the salivation promoter is peppermint oil.
In another preferred embodiment, the salivation promoter is 2.22 to 6.83wt% of the total weight of the film forming composition.
The film-forming compositions of the present invention also comprise one or more oil phases. The oil phase used in the present invention may help the active ingredient to be better compatible with other ingredients. Oil phases suitable for use in the present invention include, but are not limited to, jojoba oil, white oil, olive oil, and combinations thereof.
In another preferred embodiment, the oil phase is olive oil.
In another preferred embodiment, the oil phase is 1.39 to 4.27wt% of the total weight of the film forming composition.
The film-forming composition of the present invention may also comprise one or more defoamers. The defoamer used in the invention can reduce the generation of bubbles in a film forming system and improve the quality of film products. Defoamers suitable for use in the present invention include, but are not limited to, dimethicone, polyethylene glycol, fatty alcohols, fatty acid soaps, fatty acid esters, and combinations thereof.
In another preferred example, the defoamer is simethicone.
In another preferred embodiment, the defoamer is 0 to 1.68wt% of the total weight of the film forming composition.
In another preferred embodiment, the defoamer is 0 to 0.68wt% or 0.68 to 1.68wt% of the total weight of the film forming composition.
The film-forming composition of the present invention may also comprise one or more mold release agents. The release agent used in the invention can reduce the adhesiveness between the film agent product and the substrate film. Suitable mold release agents for use in the present invention include, but are not limited to, titanium dioxide, calcium carbonate, barium sulfate, silicon dioxide, and combinations thereof.
In another preferred embodiment, the mold release agent is titanium dioxide.
In another preferred embodiment, the release agent is 0wt% to 0.5wt% of the total weight of the oral film.
Use of the film-forming composition of the invention
The film-forming composition of the present invention can be used to prepare a film agent which can be prepared by methods well known to those skilled in the art, for example, solvent casting methods, hot melt extrusion methods, solid dispersion extrusion methods, rolling methods, coating methods, and the like.
The film may also be prepared by the method described below. The method comprises the following steps:
(1) Providing a film forming system; mixing the active ingredients, auxiliary materials and water;
(2) Defoaming the film forming system in the step (1);
(3) And (3) coating, drawing and drying the mixture obtained in the step (2) on a film forming machine to obtain the film agent.
The film forming system in the step (1) consists of active ingredients, auxiliary materials and water; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifying agent, a film forming agent, a plasticizer, a humectant, a flavoring agent, a salivation promoter and an oil phase.
The water used in step (1) may be any of the following: pure water, ultrapure water, RO water, distilled water, double distilled water, deionized water.
The film forming system in the step (1) is formed by mixing active ingredients, auxiliary materials and water. The mixing steps may be performed at the same temperature or at different temperatures. For example, the mixing step is carried out at room temperature to 90 ℃. In a preferred embodiment, the mixing step is carried out at room temperature to 50 ℃. In a preferred embodiment, the mixing step is carried out at 80 to 90 ℃. For another example, the mixing step may be performed at a lower temperature (e.g., room temperature to 50 ℃) and then at a higher temperature (e.g., 80 to 90 ℃). For another example, the mixing step may be performed at a higher temperature (e.g., 80 to 90 ℃) and then at a lower temperature (e.g., room temperature to 50 ℃).
The defoaming time in the step (2) is 1-24 hours; preferably, it can be between 6 and 12 hours. The defoaming in the step (2) may be performed under a vacuum environment or under an atmospheric environment. The defoaming in step (2) may also be performed under ultrasonic conditions.
The invention can prepare films with various thicknesses. In a preferred embodiment, the thickness of the film is 5 to 25 filaments. For example 5 to 12.5 or 12.5 to 20.
The method may further comprise the steps of: cutting the obtained film into size or shape suitable for administration; and then packaging. The unit dosage form of the film may be (1-5) cm x (1-5) cm in size. For example 2.5cm x3cm. The shape of the film agent can be square, rectangle or strip.
The invention has a plurality of advantages.
The film agent prepared from the film forming composition disclosed by the invention is not sticky and is resistant to traction. The film has good traction resistance when being coated, dried and formed, and the film is not easy to wrinkle due to overlarge elasticity and easy to crack due to overlarge elasticity.
The film agent prepared by the film forming composition has the advantages of uniform and complete appearance, uniform thickness, uniform color and no bubbles. The film agent prepared from the film forming composition has even distribution of active ingredients and accurate content of the active ingredients in each unit dosage form. The content of the active ingredient in the unit dosage form of the invention is 5 mg-80 mg. For example 5mg to 20mg or 20mg to 50mg.
The film agent prepared from the film forming composition has good water solubility. Can be completely dissolved in water within 5 seconds at the temperature of a human body; and can be completely dissolved even in 3 seconds.
The film agent prepared from the film forming composition is convenient to use and can not cause dysphagia. The film agent prepared by the film forming composition can be externally applied to the skin, can be applied to the oral mucosa or can be applied to the tongue. The film can be quickly adsorbed on the oral mucosa after entering the oral cavity, and the active ingredients can be quickly absorbed, so that the active ingredients can obtain higher bioavailability, and patients with dysphagia can take the medicine conveniently. The active ingredients in the film avoid the digestive system, thereby avoiding the influence of drug emesis on the bioavailability of the drug. The active ingredients in the film can be absorbed through the oral mucosa within a few seconds and enter the blood to exert the curative effect.
The film agent prepared from the film forming composition can be suitable for different subjects. The subject may be a mammal, such as a human or a pet. Therefore, it can be used for preparing medicines, foods or health care products for pets (such as dogs, cats and the like).
The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental methods, in which specific conditions are not noted in the following examples, are generally conducted under conventional conditions or under conditions recommended by the manufacturer.
Cannabidiol oil used in the following examples was purchased from pharmsstrip; wherein the content of cannabidiol is 95%.
The film making machines used in the following examples were purchased from Pingyang county Lushen mechanical technology Co., ltd; model OZM-360.
The peppermint oil used in the examples below had a density of 0.90g/ml.
The reagents used in the examples below were at least analytically pure.
Example 1
The formula comprises the following components:
the steps are as follows:
(1) Evenly mixing cannabis biphenol oil, beta cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia, guar gum, sucralose, peppermint oil, olive oil and water (70 mL);
(2) Standing the mixture obtained in the step (1) at room temperature to defoaming for 10 hours;
(3) And (3) uniformly coating and drawing the mixture obtained in the step (2) on a film forming machine (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain the film with the thickness of about 12 filaments.
The film prepared by the formula is not sticky and is resistant to traction. The film prepared by the formula can be kept flat in the traction process of the film preparation process, and is not easy to wrinkle, break, foam and adhere; and is easy to cut and peel.
The film was finally cut into 2.5cm by 3cm films. The film prepared in this example was tested for an active ingredient content of about 20mg per dose.
Example 2
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 1.2 | |
| Emulsifying agent | Beta cyclodextrin | 3 | 10.25 |
| Emulsifying agent | Phosphatidylcholine | 3.5 | 11.96 |
| Film forming agent | Pullulan polysaccharide | 10 | 34.16 |
| Plasticizer(s) | Propylene glycol | 7 | 23.92 |
| Film forming agent | Xanthan gum | 0.1 | 0.34 |
| Film forming agent | Acacia gum | 0.1 | 0.34 |
| Humectant type | Guar gum | 0.12 | 0.41 |
| Flavoring agent | Sucralose | 1 | 3.42 |
| Salivation promoter | Peppermint oil | 2 | 6.83 |
| Oil phase | Olive oil | 1.25 | 4.27 |
| 100％ |
The steps are as follows:
(1) Evenly mixing cannabis biphenol oil, beta cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia, guar gum, sucralose, peppermint oil, olive oil and water (80 mL);
(2) Standing the mixture obtained in the step (1) at room temperature to defoaming for 10 hours;
(3) And (3) uniformly coating and dragging the mixture obtained in the step (2) on a film making machine (the dragging speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain the film with 6 filaments.
The film prepared by the formula is not sticky and is resistant to traction. The film prepared by the formula can be kept flat in the traction process of the film preparation process, and is not easy to wrinkle, break, foam and adhere; and is easy to cut and peel.
The film was finally cut into 2.5cm by 3cm films. The film agent prepared in this example has an active ingredient content of 5mg per agent, as tested.
Example 3
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 12 | 13.38 |
| Emulsifying agent | Beta cyclodextrin | 6 | 6.69 |
| Emulsifying agent | Phosphatidylcholine | 4 | 4.46 |
| Film forming agent | Pullulan polysaccharide | 50 | 55.76 |
| Plasticizer(s) | Propylene glycol | 9 | 10.04 |
| Film forming agent | Xanthan gum | 0.15 | 0.17 |
| Film forming agent | Acacia gum | 0.15 | 0.17 |
| Humectant type | Guar gum | 0.12 | 0.13 |
| Flavoring agent | Sucralose | 5 | 5.58 |
| Salivation promoter | Peppermint oil | 2 | 2.23 |
| Oil phase | Olive oil | 1.25 | 1.39 |
| 100％ |
The steps are as follows:
(1) Evenly mixing cannabis biphenol oil, beta cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia, guar gum, sucralose, peppermint oil, olive oil and water (90 mL);
(2) Standing the mixture obtained in the step (1) at room temperature to defoaming for 10 hours;
(3) And (3) uniformly coating and dragging the mixture obtained in the step (2) on a film making machine (the dragging speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain the film with the thickness of 25 filaments.
The film prepared by the formula is not sticky and is resistant to traction. The film prepared by the formula can be kept flat in the traction process of the film preparation process, and is not easy to wrinkle, break, foam and adhere; and is easy to cut and peel.
The film was finally cut into 2.5cm by 3cm films. The film agent prepared in this example has an active ingredient content of 40mg per agent, as tested.
Example 4
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 4.8 | 7.85 |
| Emulsifying agent | Beta cyclodextrin | 3.5 | 5.72 |
| Emulsifying agent | Phosphatidylcholine | 3.75 | 6.13 |
| Film forming agent | Pullulan polysaccharide | 35 | 57.22 |
| Plasticizer(s) | Propylene glycol | 7.5 | 12.26 |
| Film forming agent | Xanthan gum | 0.125 | 0.20 |
| Film forming agent | Acacia gum | 0.125 | 0.20 |
| Humectant type | Guar gum | 0.12 | 0.20 |
| Flavoring agent | Sucralose | 3 | 4.90 |
| Salivation promoter | Peppermint oil | 2 | 3.27 |
| Oil phase | Olive oil | 1.25 | 2.04 |
| 100％ |
The steps are as follows:
(1) Evenly mixing cannabis biphenol oil, beta cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia, guar gum, sucralose, peppermint oil, olive oil and water (90 mL);
(2) Standing the mixture obtained in the step (1) at room temperature to defoaming for 10 hours;
(3) And (3) uniformly coating and drawing the mixture obtained in the step (2) on a film forming machine (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain the film with the thickness of 12 filaments.
The film prepared by the formula is not sticky and is resistant to traction. The film prepared by the formula can be kept flat in the traction process of the film preparation process, and is not easy to wrinkle, break, foam and adhere; and is easy to cut and peel.
The film was finally cut into 2.5cm by 3cm films. The film agent prepared in this example has an active ingredient content of 80mg per agent, as tested.
Example 5
The formula comprises the following components:
the steps are as follows:
(1) Evenly mixing cannabis biphenol oil, beta cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia, guar gum, sucralose, simethicone, peppermint oil, olive oil and water (70 mL);
(2) Standing the mixture obtained in the step (1) at room temperature to defoaming for 10 hours;
(3) And (3) uniformly coating and dragging the mixture obtained in the step (2) on a film making machine (the dragging speed is 0.1-0.5 m/s), drying at 60-80 ℃ and drying at 70-80 ℃ to obtain the film with the thickness of 6 filaments.
The film prepared by the formula is not sticky and is resistant to traction. The film prepared by the formula can be kept flat in the traction process of the film preparation process, and is not easy to wrinkle, break, foam and adhere; and is easy to cut and peel.
The film was finally cut into 2.5cm by 3cm films. The film prepared in this example was tested for an active ingredient content of about 10mg per dose.
Comparative example 1
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 1.25 | 2.32 |
| Emulsifying agent | Beta cyclodextrin | 3.5 | 6.50 |
| Emulsifying agent | Phosphatidylcholine | 0 | 0.00 |
| Film forming agent | Pullulan polysaccharide | 35 | 64.97 |
| Plasticizer(s) | Propylene glycol | 7.5 | 13.92 |
| Film forming agent | Xanthan gum | 0.125 | 0.23 |
| Film forming agent | Acacia gum | 0.125 | 0.23 |
| Humectant type | Guar gum | 0.12 | 0.22 |
| Flavoring agent | Sucralose | 3 | 5.57 |
| Salivation promoter | Peppermint oil | 2 | 3.71 |
| Oil phase | Olive oil | 1.25 | 2.32 |
| 100％ |
The procedure is as in example 1; comparative example 1 differs from example 1 in that the use of phosphatidylcholine was removed from the formulation of comparative example 1. As a result, the surface of the film prepared by the formula has cannabidiol oil, so that the adhesion phenomenon of the film is serious, and the content of the active ingredients of the final film agent is inaccurate.
Comparative example 2
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 1.25 | 2.17 |
| Emulsifying agent | Beta cyclodextrin | 3.5 | 6.07 |
| Emulsifying agent | Phosphatidylcholine | 3.75 | 6.51 |
| Film forming agent | Pullulan polysaccharide | 35 | 60.74 |
| Plasticizer(s) | Propylene glycol | 7.5 | 13.02 |
| Film forming agent | Carrageenan gum | 0.125 | 0.22 |
| Film forming agent | Acacia gum | 0.125 | 0.22 |
| Humectant type | Guar gum | 0.12 | 0.21 |
| Flavoring agent | Sucralose | 3 | 5.21 |
| Salivation promoter | Peppermint oil | 2 | 3.47 |
| Oil phase | Olive oil | 1.25 | 2.17 |
| 100％ |
The procedure is as in example 1; comparative example 2 differs from example 1 in that the formulation of comparative example 2 replaced xanthan gum with carrageenan. As a result, the films produced from the formulation become brittle and very brittle.
Comparative example 3
The formula comprises the following components:
| component name | Dosage (g) | Percentage (wt%) | |
| Active ingredient | Cannabidiol oil | 1.25 | 2.16 |
| Emulsifying agent | Beta cyclodextrin | 3.5 | 6.05 |
| Emulsifying agent | Phosphatidylcholine | 3.75 | 6.48 |
| Film forming agent | Pullulan polysaccharide | 35 | 60.50 |
| Plasticizer(s) | Propylene glycol | 7.5 | 12.96 |
| Film forming agent | Xanthan gum | 0.125 | 0.22 |
| Film forming agent | Acacia gum | 0.125 | 0.22 |
| Humectant type | Guar gum | 0.35 | 0.61 |
| Flavoring agent | Sucralose | 3 | 5.19 |
| Salivation promoter | Peppermint oil | 2 | 3.46 |
| Oil phase | Olive oil | 1.25 | 2.16 |
| 100％ |
The procedure is as in example 1; comparative example 3 differs from example 1 in that the amount of guar gum was increased from 0.12g to 0.35g. As a result, the films produced from this formulation are not tacky, but the films are stretched. In the drawing process of the film making process, the film prepared by the formula cannot be kept flat, is extremely easy to wrinkle, has high product reject ratio in the production process, and cannot obtain a film agent with accurate dosage in the production process.
Test example 1 dissolution time in Water
The films prepared in examples 1 to 5 were taken to give 2.5cm x3cm films for testing the dissolution time in water.
The films prepared in examples 1 to 5 were all found to be completely dissolved in water in 3 seconds by placing a beaker containing 50ml of distilled water in a constant temperature bath at 37.+ -. 2 ℃ and adding 2.5cm x3cm of the films prepared in examples 1 to 5 with stirring.
The films prepared in examples 1 to 5 were used for oral administration. The film agent can be quickly adsorbed on the oral mucosa and quickly dissolved after entering the oral cavity, so that the active ingredients can be quickly absorbed.
The films prepared in examples 1 to 5 can also be used for external application, for example, the film can be directly attached to skin with acne, wound or pigment, and can effectively relieve symptoms of the part.
50 acne patients were recruited as volunteers. Wherein 25 patients did not use the films prepared in examples 1 to 5; while another 25 patients used the films prepared in examples 1 to 5 (the films were directly applied to the acne sites). As a result, it was found that the red swelling at the whelk was significantly resolved after 24 hours of using the film agent of the present invention; and the acne of the patient who does not use the film of the invention is not relieved.
The film agent prepared by the formula of the invention has the advantages of uniform and complete appearance, uniform thickness, uniform color and no bubbles.
The film prepared by the formula of the invention is not sticky, is resistant to traction (keeps smooth, is not wrinkled and is not broken in the traction process), and is easy to cut (the cutting edge is not broken and is neat) and peel. The product percent of pass is extremely high (the percent of pass exceeds 99 percent) in the film making process; and the film agent is instant in water, which is beneficial to improving bioavailability.
All documents mentioned in this application are incorporated by reference as if each were individually incorporated by reference. Further, it will be appreciated that various changes and modifications may be made by those skilled in the art after reading the above teachings, and such equivalents are intended to fall within the scope of the claims appended hereto.
Claims (7)
1. A film-forming composition, characterized in that it comprises an active ingredient and an auxiliary material; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifying agent, a film forming agent, a plasticizer, a humectant, a flavoring agent, a salivation promoter and an oil phase;
the emulsifying agent is phosphatidylcholine and beta cyclodextrin;
the film forming agent is pullulan, xanthan gum and acacia;
the humectant is guar gum;
the weight of the humectant accounts for 0.13-0.5-wt% of the total weight of the film-forming composition.
2. The film-forming composition of claim 1, wherein the plasticizer is selected from the group consisting of: propylene glycol, ethylene glycol, glycerin, triacetin, triacetyl citrate, polypropylene glycol, polyethylene glycol, mineral oil, and combinations thereof.
3. The film-forming composition of claim 1, wherein the flavoring agent is selected from the group consisting of: sucralose, sucrose, glucose, sodium saccharin, fructose, xylitol, stevioside, acesulfame potassium, maltose, mannitol, saccharin, citric acid, licorice, fruit juice, aspartame, honey, and combinations thereof; or the flavoring agent is an organic oil from one or more of the following plants: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry, blueberry.
4. The film-forming composition of claim 1, wherein the film-forming composition further comprises an antifoaming agent.
5. A film-forming system, characterized in that it consists of a film-forming composition according to any one of claims 1 to 4 and water.
6. Use of the film-forming composition according to claim 1, for the preparation of an oral or external preparation.
7. Use of a film-forming composition according to claim 1 for the preparation of a medicament.
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