CN111228241A - Film forming composition and application thereof - Google Patents

Film forming composition and application thereof Download PDF

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Publication number
CN111228241A
CN111228241A CN202010056963.9A CN202010056963A CN111228241A CN 111228241 A CN111228241 A CN 111228241A CN 202010056963 A CN202010056963 A CN 202010056963A CN 111228241 A CN111228241 A CN 111228241A
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film
forming composition
agent
oil
gum
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CN111228241B (en
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全越
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/03—Organic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/10—Foods or foodstuffs containing additives; Preparation or treatment thereof containing emulsifiers
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to a film-forming composition and application thereof, and specifically the film-forming composition comprises cannabidiol oil and auxiliary materials such as an emulsifier, a film-forming agent, a plasticizer, a humectant and the like. The film prepared by the film-forming composition can be dissolved in water quickly, is not sticky and resistant to drawing, is not easy to wrinkle and break in the film-forming process, and has high product quality and high yield.

Description

Film forming composition and application thereof
Technical Field
The invention belongs to the field of film preparation, and particularly relates to a film-forming composition containing a cannabis oily extract and application thereof.
Background
Cannabis sativa L, also called Cannabis sativa or Cannabis sativa, is a plant of the genus Cannabis of the family Moraceae. The cannabidiol component contained in cannabis is a phenolic compound which has not been isolated from other animals and plants at present. Cannabidiol is a non-addictive component and has high medicinal value. The research shows that if cannabidiol is reasonably applied to medicine, the cannabidiol has the functions of resisting epilepsy, resisting psychosis, resisting depression, relieving pain, relieving nausea caused by cancer chemotherapy, treating asthma and the like. Cannabidiol is also a powerful antioxidant, has the functions of blocking the adverse effects of certain drugs on human nerves, and has a series of physiological activities such as blocking breast cancer metastasis, resisting rheumatoid arthritis, resisting insomnia and the like.
Because of the pharmaceutical value of cannabidiol, more and more cannabidiol formulations are being developed. However, existing cannabidiol formulations suffer from a number of disadvantages, for example, cannabidiol administered orally does not always have a rapid onset of action. There are also some pediatric and/or geriatric patients who have difficulty taking oral formulations due to an inability to swallow, nausea or other gastrointestinal problems. In addition, the 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 generally cannot include a high loading of active ingredient.
Therefore, how to obtain a preparation with cannabidiol as an active ingredient, which has accurate unit dosage form content and convenient use, is an important research direction in the field.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and aims to provide a film-forming composition containing cannabidiol oil, which is used for preparing a film agent which is not sticky, has accurate unit dosage form content, is convenient to use and has 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 emulsifier, a film-forming agent, a plasticizer, a humectant, a flavoring agent, a salivation accelerator 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, poloxamer, cholesterol, octyldodecanol, polyoxylglyceride, Labrasol, Labrafil, Pluronics, polysorbate, ethyl linoleate, monoglycerides, diglycerides, triglycerides, sodium bis (2-ethylhexyl) sulfosuccinate, sodium monomethylnaphthalenesulfonate, sodium dimethylnaphthalenesulfonate, tocopheryl acetate, Solutol, soybean oil, Capmuls, sodium lauryl sulfate, sorbitol ester, sorbitan, stearic acid, tween, bile salts, fatty acids, and combinations thereof.
In a preferred embodiment, the film forming agent 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, polyvinyl pyrrolidone, polyethylene oxide, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl copolymer, ethyl cellulose, hydroxypropyl ethylcellulose, 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, 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 organic oil from one or more plants in the following group: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry and 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 invention provides a film forming system, which consists of an active ingredient, an auxiliary material and water; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifier, a film-forming agent, a plasticizer, a humectant, a flavoring agent, a salivation accelerator and an oil phase.
The third aspect of the present invention provides the use of the film-forming composition of the first aspect for the preparation of an oral preparation or an external preparation.
In a fourth aspect, the present invention provides the use of the film-forming composition of the first aspect for the manufacture of a medicament, food or nutraceutical.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.
Detailed Description
As used herein, the term "room temperature" means a temperature of 15-30 ℃.
As used herein, the term "filament" is 0.1 mm.
As used herein, "about" means within ± 10% of the defined range; preferably within + -5%.
Unless otherwise indicated, percentages and parts used herein are by weight.
film-Forming composition of the invention
The film-forming composition of the present invention comprises an active ingredient and an adjuvant for the preparation of a fast dissolving film.
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 comprising cannabidiol. It may be extracted from cannabis according to known methods by the inventors 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 greater than or equal to 80%.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of 85% or greater.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of greater than or equal to 90%.
In another preferred embodiment, the cannabidiol oil used in the present invention has a cannabidiol content of greater than or equal to 95%.
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 accounts for 1.51-29.95 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the active ingredient accounts for 1.51-13.38 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the active ingredient accounts for 2.15-29.95 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the active ingredient accounts for 2.15-13.38 wt% of the total weight of the film-forming composition.
The film-forming compositions of the present invention are formulated to form films for oral administration which dissolve and release the active ingredient rapidly upon contact with saliva. Therefore, the selection of appropriate excipients has a critical role for the formulation to be prepared. In addition, the adjuvants used in the film-forming compositions should be well compatible with the active ingredients and non-toxic to the subject.
Emulsifiers useful in the present invention can render the active ingredient cannabidiol oil well compatible with other ingredients include, but are not limited to, cyclodextrins (e.g., β cyclodextrin), phospholipids, phosphatidylcholine (or lecithin), polyethylene glycol, tocopheryl polyethylene glycol succinate, Cremophor (e.g., nonionic polyethoxylated detergents), Lutrol, poloxamers (e.g., polyethylene-polypropylene glycol), cholesterol, octyldodecanol, polyglycerol esters, Labrasol, Labrafil, Pluronics, polysorbates, ethyl linoleate, monoglycerides (e.g., capric acid monoglyceride, caprylic acid monoglyceride), diglycerides (e.g., capric acid diglyceride, caprylic acid diglyceride), triglycerides, sodium bis (2-ethylhexyl) sulfosuccinate, sodium monomethylnapthalene, dimethylnapthalene, acetic acid ester, soybean oil, soy oil, sodium lauryl sulfate, sodium oleate, sodium lauryl sulfate, sodium oleate, sodium lauryl sulfate, sodium oleate.
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 1560 (polyoxyethylene (20) sorbitan monostearate), polysorbate 80 (polyoxyethylene (20) sorbitan monooleate).
In another preferred embodiment, the emulsifier is selected from the group consisting of β cyclodextrin, phospholipids, phosphatidylcholine, poloxamer, cholesterol, octyldodecanol, polyoxylglycerides, Labrasol, Labrafil, Pluronics, polysorbate, ethyl linoleate, capric acid monoglycerides, caprylic acid monoglycerides, capric acid diglycerides, caprylic acid diglycerides, 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 β cyclodextrins, phospholipids, phosphatidylcholines, poloxamers, cholesterol, Labrasol, Labrafil, Pluronics, ethyl linoleate, capric acid monoglycerides, caprylic acid monoglycerides, capric acid diglycerides, caprylic acid diglycerides, triglycerides, Solutol, Capmuls, sodium lauryl sulfate, tweens, and combinations thereof.
In another preferred embodiment, the emulsifier is selected from the group consisting of β cyclodextrin, phosphatidylcholine, poloxamer, cholesterol, tween, and combinations thereof.
In another preferred embodiment, the emulsifier is a combination of β cyclodextrin and phosphatidylcholine.
In another preferred embodiment, the emulsifier is a combination of β cyclodextrin and a poloxamer.
In another preferred embodiment, the emulsifier is a combination of β cyclodextrin and tween.
In another preferred embodiment, the emulsifier accounts for 7.34-32.03 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the emulsifier accounts for 7.34-22.21 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the emulsifier accounts for 11.15-32.03 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the emulsifier accounts for 11.15-22.21 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the emulsifier is β cyclodextrin and phosphatidylcholine, β cyclodextrin is 3.44-18.59 wt% (preferably 3.44-10.25 wt%, or preferably 5.72-18.59 wt%, or preferably 5.72-10.25 wt%) of the total weight of the film-forming composition, and phosphatidylcholine is 3.9-13.44 wt% (preferably 3.9-11.96 wt%, or preferably 4.46-13.44 wt%, or preferably 4.46-11.96 wt%) of the total weight of the film-forming composition.
The inventor screens other emulsifiers, and finds that different emulsifiers have large difference on the emulsification effect of the cannabidiol oil. The emulsifier screened by the invention can enable the cannabidiol oil to be compatible with other components better, and the obtained film agent is not sticky and is resistant to drawing, and easy to produce and cut.
The film-forming compositions of the present invention also comprise one or more film-forming agents. The film forming agent used in the invention has good compatibility with active ingredients. Film-forming agents 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 copolymer, carboxyvinyl copolymer, ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, calcium phosphate, talc, calcium silicate, calcium carbonate, and combinations thereof.
In another preferred embodiment, the film forming agent 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 forming agent is selected from the group consisting of: pullulan, starch, xanthan gum, gum arabic, guar gum, pectin, gelatin, and combinations thereof.
In another preferred embodiment, the film forming agent is a combination of pullulan, xanthan gum and arabic gum.
In another preferred embodiment, the film forming agent accounts for 20.15-73.20 wt% of the total weight of the film forming composition.
In another preferred embodiment, the film forming agent accounts for 20.15-61.18 wt% of the total weight of the film forming composition.
In another preferred embodiment, the film forming agent accounts for 34.85-73.20 wt% of the total weight of the film forming composition.
In another preferred embodiment, the film forming agent accounts for 34.85-61.18 wt% of the total weight of the film forming composition.
In another preferred embodiment, the film forming agent is pullulan, xanthan gum and arabic gum; pullulan accounts for 19.93-72.18 wt% (preferably 19.93-60.74 wt%, or preferably 34.16-72.18 wt%, or preferably 34.16-60.74 wt%) of the total weight of the film-forming composition; xanthan gum is 0.11-0.51 wt% (preferably 0.11-0.34 wt%, or preferably 0.17-0.51 wt%, or preferably 0.17-0.34 wt%) of the total weight of the film forming composition; the gum arabic is 0.11-0.51 wt% (preferably 0.11-0.34 wt%, or preferably 0.17-0.51 wt%, or preferably 0.17-0.34 wt%) of the total weight of the film-forming composition.
The film-forming compositions of the present invention also comprise one or more plasticizers. The plasticizer 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 glycerin.
In another preferred embodiment, the plasticizer is 7.94 to 28.78 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the plasticizer is 7.94 to 23.92 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the plasticizer is 10.04 to 28.78 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the plasticizer is 10.04 to 23.92 wt% of the total weight of the film-forming composition.
The film-forming compositions of the present invention also comprise 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 example, the humectant is sorbitol.
In another preferred embodiment, the humectant is polyethylene glycol.
In another preferred embodiment, the humectant accounts for 0.13 to 0.5 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the humectant accounts for 0.13 to 0.41 wt% of the total weight of the film-forming composition.
The inventor screens the amount of the humectant, and as a result, found that if the content of the humectant exceeds 0.5%, the film-forming system can produce a film which is not resistant to drawing, and is easy to stretch and wrinkle during film drawing, so that the produced film has uneven appearance and is not easy to cut, and the content of the active ingredient in 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 by 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, glucose, sodium saccharin, fructose, xylitol, stevia, acesulfame potassium, maltose, mannitol, saccharin, citric acid, licorice, fruit juices, aspartame, honey, and combinations thereof.
In another preferred embodiment, the flavoring agent is an organic oil from one or more plants of the following group: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry and 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 accounts for 1.16-15.03 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the flavoring agent accounts for 1.16-5.58 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the flavoring agent accounts for 3.42-15.03 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the flavoring agent accounts for 3.42-5.58 wt% of the total weight of the film-forming composition.
The film-forming composition of the present invention further comprises one or more salivation enhancers. The salivation promoter used in the invention can promote salivation of a subject and accelerate dissolution of a film agent in an oral cavity. Salivation enhancers suitable for use in the present invention include, but are not limited to, peppermint oil, citric acid, malic acid, lactic acid, tartaric acid, and combinations thereof.
In another preferred embodiment, the salivation enhancer is peppermint oil.
In another preferred embodiment, the salivation enhancer is present in an amount of 2.22 to 6.83 wt% based on 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 more compatible with the 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 example, the oil phase is olive oil.
In another preferred embodiment, the oil phase accounts for 1.39-4.27 wt% of the total weight of the film-forming composition.
The film-forming composition of the present invention may further comprise one or more defoamers. The defoaming agent used in the invention can reduce the generation of bubbles in a film forming system and improve the quality of film agent products. Defoamers suitable for use in the present invention include, but are not limited to, dimethicone, polydimethylsiloxane, polyethylene glycol, fatty alcohol, fatty acid soap, fatty acid ester, and combinations thereof.
In another preferred example, the defoaming agent is dimethyl silicone oil.
In another preferred embodiment, the defoaming agent is 0 to 1.68 wt% of the total weight of the film-forming composition.
In another preferred embodiment, the defoaming agent is 0 to 0.68 wt% or 0.68 to 1.68 wt% of the total weight of the film-forming composition.
The film-forming compositions of the present invention may also comprise one or more release agents. The release agent used in the invention can reduce the adhesion of a film agent product and a basement membrane. Suitable mold release agents for use in the present invention include, but are not limited to, titanium dioxide, calcium carbonate, barium sulfate, silica, and combinations thereof.
In another preferred example, the release agent is titanium dioxide.
In another preferred embodiment, the release agent is 0 wt% to 0.5 wt% of the total weight of the oral film agent.
Use of the film-forming composition of the invention
The film-forming composition of the present invention can be used for the preparation of a film, which can be prepared by a method well known to those skilled in the art, for example, a solvent casting method, a hot-melt extrusion method, a solid dispersion extrusion method, a rolling method, a coating method, etc.
The film dosage may also be prepared by the methods described below. The method comprises the following steps:
(1) providing a film forming system; mixing the active ingredient, the 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 making 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 emulsifier, a film-forming agent, a plasticizer, a humectant, a flavoring agent, a salivation accelerator and an oil phase.
The water used in step (1) may be any one of the following: pure water, ultrapure water, RO water, distilled water, double distilled water and deionized water.
The film forming system in the step (1) is formed by mixing active ingredients, auxiliary materials and water. The mixing step may be carried out 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 can 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 can be performed first 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 may be between 6 and 12 hours. The defoaming in the step (2) can be performed in a vacuum environment or a normal pressure environment. The defoaming of step (2) may also be carried out under ultrasonic conditions.
The invention can prepare film agent with various thickness. In a preferred example, the thickness of the film agent is 5 to 25 filaments. For example, 5 to 12.5 or 12.5 to 20 filaments.
The method may further comprise the steps of: cutting the obtained pellicle into suitable size or shape for administration; and then packaging. The unit dosage form of the film agent can be (1-5) cm x (1-5) cm in size. For example 2.5cm x3 cm. The shape of the film agent can be square, rectangle or strip.
The invention has many advantages.
The film agent prepared by the film forming composition is not sticky and is resistant to traction. The film has good drawing resistance when being coated, dried and formed into a film, and the film is not easy to wrinkle because of too high elasticity, and is not easy to crack because of too low elasticity.
The film agent prepared by the film forming composition has uniform and complete appearance, uniform thickness, uniform color and no bubbles. The film agent prepared by the film forming composition has uniform distribution of active ingredients, and the content of the active ingredients in each unit dosage form is accurate. The unit dosage form of the invention has a content of active ingredient of 5mg to 80 mg. For example, 5mg to 20mg or 20mg to 50 mg.
The film agent prepared by the film forming composition has good water solubility. Can be completely dissolved in water within 5 seconds at the temperature of human body; and can be completely dissolved even within 3 seconds.
The film agent prepared by the film forming composition is convenient to use and can not cause dysphagia. The film agent prepared from the film forming composition can be applied to skin for external use, oral mucosa or sublingual administration. The film agent can be quickly adsorbed on oral mucosa after entering the oral cavity and enables active ingredients to be quickly absorbed, so that the active ingredients obtain higher bioavailability and the film agent is convenient for patients with dysphagia to take the medicine. The active ingredients in the pellicle avoid digestive system, thereby avoiding influence of emesis on bioavailability of the medicine. The active ingredients in the film agent can be absorbed through oral mucosa within a few seconds and enter blood to exert curative effect.
The film agent prepared by the film forming composition can be suitable for different subjects. The subject may be a mammal, such as a human or a pet. Therefore, the compound can be used for preparing medicines, foods or health care products for pets (such as dogs, cats and other pets).
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers.
Cannabidiol oil used in the following examples was purchased from Pharmstrip; wherein, the content of cannabidiol is 95%.
The film making machine adopted in the following examples was purchased from Pingyang county Rui Sheng mechanical science and technology, LLC; the model numbers are OZM-360.
The density of the peppermint oil used in the examples below was 0.90 g/ml.
The reagents used in the following examples were at least analytically pure.
Example 1
The formula is as follows:
Figure BDA0002369829160000101
Figure BDA0002369829160000111
the method comprises the following steps:
(1) mixing cannabidiol oil, β cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, acacia gum, guar gum, sucralose, peppermint oil, olive oil and water (70mL) uniformly;
(2) standing and defoaming the mixture obtained in the step (1) at room temperature for 10 hours;
(3) and (3) uniformly coating the mixture obtained in the step (2) on a film making machine, drawing (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain a film with the thickness of about 12 filaments.
The film prepared by the formula is not sticky and is resistant to drawing. The film prepared by the formula can keep flat in the traction process of the film preparation process, is not easy to wrinkle, break, bubble or adhere; and is easy to cut and peel.
Finally, the film was cut into 2.5cm x3cm films. The active ingredient content of the film formulations prepared in this example was tested to be about 20mg per dose.
Example 2
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 1.2
Emulsifier β Cyclodextrin 3 10.25
Emulsifier Phosphatidylcholine 3.5 11.96
Film forming agent Pullulan polysaccharide 10 34.16
Plasticizer Propylene glycol 7 23.92
Film forming agent Xanthan gum 0.1 0.34
Film forming agent Arabic gum 0.1 0.34
Moisture-retaining agent Guar gum 0.12 0.41
Flavouring agent Sucralose 1 3.42
Saliva secretion promoter Mint oil 2 6.83
Oil phase Olive oil 1.25 4.27
100％
The method comprises the following steps:
(1) mixing cannabidiol oil, β cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, arabic gum, guar gum, sucralose, peppermint oil, olive oil and water (80mL) uniformly;
(2) standing and defoaming the mixture obtained in the step (1) at room temperature for 10 hours;
(3) and (3) uniformly coating the mixture obtained in the step (2) on a film making machine, drawing (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain a film with the thickness of 6 filaments.
The film prepared by the formula is not sticky and is resistant to drawing. The film prepared by the formula can keep flat in the traction process of the film preparation process, is not easy to wrinkle, break, bubble or adhere; and is easy to cut and peel.
Finally, the film was cut into 2.5cm x3cm films. The content of active ingredient in the film agent prepared in this example was tested to be 5mg per dose.
Example 3
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 12 13.38
Emulsifier β Cyclodextrin 6 6.69
Emulsifier Phosphatidylcholine 4 4.46
Film forming agent Pullulan polysaccharide 50 55.76
Plasticizer Propylene glycol 9 10.04
Film forming agent Xanthan gum 0.15 0.17
Film forming agent Arabic gum 0.15 0.17
Moisture-retaining agent Guar gum 0.12 0.13
Flavouring agent Sucralose 5 5.58
Saliva secretion promoter Mint oil 2 2.23
Oil phase Olive oil 1.25 1.39
100％
The method comprises the following steps:
(1) mixing cannabidiol oil, β cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, arabic gum, guar gum, sucralose, peppermint oil, olive oil and water (90mL) uniformly;
(2) standing and defoaming the mixture obtained in the step (1) at room temperature for 10 hours;
(3) and (3) uniformly coating the mixture obtained in the step (2) on a film making machine, drawing (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain a film with the thickness of 25 filaments.
The film prepared by the formula is not sticky and is resistant to drawing. The film prepared by the formula can keep flat in the traction process of the film preparation process, is not easy to wrinkle, break, bubble or adhere; and is easy to cut and peel.
Finally, the film was cut into 2.5cm x3cm films. The content of active ingredient in the film agent prepared in this example was tested to be 40mg per dose.
Example 4
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 4.8 7.85
Emulsifier β Cyclodextrin 3.5 5.72
Emulsifier Phosphatidylcholine 3.75 6.13
Film forming agent Pullulan polysaccharide 35 57.22
Plasticizer Propylene glycol 7.5 12.26
Film forming agent Xanthan gum 0.125 0.20
Film forming agent Arabic gum 0.125 0.20
Moisture-retaining agent Guar gum 0.12 0.20
Flavouring agent Sucralose 3 4.90
Saliva secretion promoter Mint oil 2 3.27
Oil phase Olive oil 1.25 2.04
100％
The method comprises the following steps:
(1) mixing cannabidiol oil, β cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, arabic gum, guar gum, sucralose, peppermint oil, olive oil and water (90mL) uniformly;
(2) standing and defoaming the mixture obtained in the step (1) at room temperature for 10 hours;
(3) and (3) uniformly coating the mixture obtained in the step (2) on a film making machine, drawing (the drawing speed is 0.1-0.5 m/s), and drying at 60-80 ℃ to obtain a film with the thickness of 12 filaments.
The film prepared by the formula is not sticky and is resistant to drawing. The film prepared by the formula can keep flat in the traction process of the film preparation process, is not easy to wrinkle, break, bubble or adhere; and is easy to cut and peel.
Finally, the film was cut into 2.5cm x3cm films. The content of active ingredient in the film agent prepared in this example was tested to be 80mg per dose.
Example 5
The formula is as follows:
Figure BDA0002369829160000131
Figure BDA0002369829160000141
the method comprises the following steps:
(1) mixing cannabidiol oil, β cyclodextrin, phosphatidylcholine, pullulan, propylene glycol, xanthan gum, arabic gum, guar gum, sucralose, simethicone, peppermint oil, olive oil and water (70mL) uniformly;
(2) standing and defoaming the mixture obtained in the step (1) at room temperature for 10 hours;
(3) and (3) uniformly coating and drawing the mixture obtained in the step (2) on a film making machine (the drawing speed is 0.1-0.5 m/s), drying at 60-80 ℃, and drying at 70-80 ℃ to obtain a film with the thickness of 6 filaments.
The film prepared by the formula is not sticky and is resistant to drawing. The film prepared by the formula can keep flat in the traction process of the film preparation process, is not easy to wrinkle, break, bubble or adhere; and is easy to cut and peel.
Finally, the film was cut into 2.5cm x3cm films. The active ingredient content of the film formulations prepared in this example was tested to be about 10mg per dose.
Comparative example 1
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 1.25 2.32
Emulsifier β Cyclodextrin 3.5 6.50
Emulsifier Phosphatidylcholine 0 0.00
Film forming agent Pullulan polysaccharide 35 64.97
Plasticizer Propylene glycol 7.5 13.92
Film forming agent Xanthan gum 0.125 0.23
Film forming agent Arabic gum 0.125 0.23
Moisture-retaining agent Guar gum 0.12 0.22
Flavouring agent Sucralose 3 5.57
Saliva secretion promoter Mint oil 2 3.71
Oil phase Olive oil 1.25 2.32
100％
The operation procedure is the same as in example 1; comparative example 1 differs from example 1 in that the formulation of comparative example 1 eliminates the use of phosphatidylcholine. As a result, cannabidiol oil exists on the surface of the film prepared by the formula, so that the film adhesion phenomenon is serious, and the content of active ingredients of the final film agent is not accurate.
Comparative example 2
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 1.25 2.17
Emulsifier β Cyclodextrin 3.5 6.07
Emulsifier Phosphatidylcholine 3.75 6.51
Film forming agent Pullulan polysaccharide 35 60.74
Plasticizer Propylene glycol 7.5 13.02
Film forming agent Carrageenan 0.125 0.22
Film forming agent Arabic gum 0.125 0.22
Moisture-retaining agent Guar gum 0.12 0.21
Flavouring agent Sucralose 3 5.21
Saliva secretion promoter Mint oil 2 3.47
Oil phase Olive oil 1.25 2.17
100％
The operation procedure is the same as in example 1; comparative example 2 differs from example 1 in that the formulation of comparative example 2 has carrageenan instead of xanthan gum. As a result, the films produced by the formulation are brittle and easily broken.
Comparative example 3
The formula is as follows:
name of ingredient Dosage (g) Percent (wt%)
Active ingredient Cannabidiol oil 1.25 2.16
Emulsifier β Cyclodextrin 3.5 6.05
Emulsifier Phosphatidylcholine 3.75 6.48
Film forming agent Pullulan polysaccharide 35 60.50
Plasticizer Propylene glycol 7.5 12.96
Film forming agent Xanthan gum 0.125 0.22
Film forming agent Arabic gum 0.125 0.22
Moisture-retaining agent Guar gum 0.35 0.61
Flavouring agent Sucralose 3 5.19
Saliva secretion promoter Mint oil 2 3.46
Oil phase Olive oil 1.25 2.16
100％
The operation procedure is the same as in example 1; comparative example 3 differs from example 1 in that the amount of guar gum was increased from 0.12g to 0.35 g. As a result, the film produced from the formulation is not sticky, but the film is stretched. In the drawing process of the film preparation process, the film prepared by the formula cannot be kept flat and is easy to wrinkle, the product qualification rate is high in the production process, and the film agent with accurate dosage cannot be obtained in the production process.
Test example 1 dissolution time in Water
2.5cm x3cm films from examples 1 to 5 were tested for dissolution time in water.
A beaker containing 50ml of distilled water was placed in a thermostatic bath at 37. + -. 2 ℃ and 2.5cm X3cm films obtained in examples 1 to 5 were added with stirring, and it was found that all the films obtained in examples 1 to 5 were completely dissolved in water within 3 seconds.
The films prepared in examples 1 to 5 can be used for oral administration. The film agent can be quickly adsorbed on oral mucosa and quickly dissolved after entering 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 is directly stuck on skin with whelk, wound or pigment, and can effectively relieve the symptoms of the part.
50 whelk patients were recruited as volunteers. Among them, 25 patients did not use the film prepared in examples 1 to 5; the films prepared in examples 1 to 5 were used by another 25 patients (the films were directly applied to the whelk). The result shows that the acne red and swelling obviously subsides after the film agent is used for 24 hours; and the acne of the patient who does not use the film agent has no relief.
The film agent prepared by the formula has uniform and complete appearance, uniform thickness, uniform color and no bubbles.
The film agent prepared by the formula is not sticky, is resistant to traction (keeps flat, does not wrinkle and does not break in the traction process), and is easy to cut (the cut edge is not broken and neat) and peel. The product yield in the film making process is extremely high (the yield is over 99 percent); the film agent is instant in water, and is favorable for improving bioavailability.
All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.

Claims (10)

1. A film-forming composition comprising an active ingredient and an adjuvant; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifier, a film-forming agent, a plasticizer, a humectant, a flavoring agent, a salivation accelerator and an oil phase.
2. The film forming composition of claim 1, wherein the emulsifier is selected from the group consisting of: cyclodextrin, phospholipids, phosphatidylcholine, polyethylene glycol, tocopheryl polyethylene glycol succinate, Cremophor, Lutrol, poloxamer, cholesterol, octyldodecanol, polyoxylglyceride, Labrasol, Labrafil, Pluronics, polysorbate, ethyl linoleate, monoglycerides, diglycerides, triglycerides, sodium bis (2-ethylhexyl) sulfosuccinate, sodium monomethylnaphthalenesulfonate, sodium dimethylnaphthalenesulfonate, tocopheryl acetate, Solutol, soybean oil, Capmuls, sodium lauryl sulfate, sorbitol ester, sorbitan, stearic acid, tween, bile salts, fatty acids, and combinations thereof.
3. The film-forming composition of claim 1, wherein the film-forming agent 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, polyvinyl pyrrolidone, polyethylene oxide, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl copolymer, ethyl cellulose, hydroxypropyl ethylcellulose, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, calcium phosphate, talc, calcium silicate, calcium carbonate, and combinations thereof.
4. The film-forming composition of claim 1, wherein the plasticizer is selected from the group consisting of: propylene glycol, ethylene glycol, glycerin, triacetin, polypropylene glycol, polyethylene glycol, mineral oil, and combinations thereof.
5. The film forming composition of claim 1, wherein the humectant is selected from the group consisting of: guar gum, sorbitol, glycerin, propylene glycol, polyethylene glycol, and combinations thereof.
6. 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 organic oil from one or more plants in the following group: ginger, fennel, cinnamon, mint, sweet orange, lavender, orange, cherry, mango, strawberry and blueberry.
7. The film-forming composition of claim 1, further comprising an antifoaming agent.
8. A film forming system is characterized in that the film forming system consists of active ingredients, auxiliary materials and water; the active ingredient is cannabidiol oil; the auxiliary materials comprise an emulsifier, a film-forming agent, a plasticizer, a humectant, a flavoring agent, a salivation accelerator and an oil phase.
9. Use of the film-forming composition according to claim 1 for the preparation of an oral or topical formulation.
10. Use of the film-forming composition according to claim 1 for the preparation of a medicament, food or nutraceutical.
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