US20100055174A1 - Chewable softgel capsules - Google Patents
Chewable softgel capsules Download PDFInfo
- Publication number
- US20100055174A1 US20100055174A1 US12/543,435 US54343509A US2010055174A1 US 20100055174 A1 US20100055174 A1 US 20100055174A1 US 54343509 A US54343509 A US 54343509A US 2010055174 A1 US2010055174 A1 US 2010055174A1
- Authority
- US
- United States
- Prior art keywords
- starches
- starch
- native
- chemically modified
- modified
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- 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
- A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
- A23L27/70—Fixation, conservation, or encapsulation of flavouring agents
- A23L27/72—Encapsulation
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
Definitions
- the present invention relates generally to soft gelatin capsules and in particular, to soft gelatin capsules having a chewable consistency.
- ingredients are encapsulated in a gelatin shell for consumption.
- the shell of a soft gelatin capsule comprises gelatin and a plasticizer to control the softness and flexibility of the shell.
- the shell further includes water and optionally other additives such as flavorants.
- the shells are typically dried until the water content is decreased to a certain level so as to prevent the capsule from being deformed or becoming undesirably sticky.
- Soft gelatin capsules with acceptable dosing, stability, and storage and handling characteristics are typical when a relatively high gelatin content and a relatively low plasticizer and end water content is found in the capsules.
- the chewability, texture and mouth feel, and client acceptance of the capsules are found when a lower gelatin content and higher plasticizer and end water contents is used.
- chewable soft gelatin capsules or chewable softgels
- these chewable softgels are intended to be completely or nearly completely dissolved by chewing.
- Such capsules are distinguished by particular fabrication problems, such as excessive stickiness during encapsulation and sticking of the end product to other capsules during post-encapsulation handling.
- chewable softgels with high end water content typically have poor storage performance, sticking to one another in packaging and often melting or leaking during storage.
- chewability of capsules can be affected by the bloom strength and the melting points of the gelatin used. In general, gelatins of lower bloom strength and lower melting point have preferable organoleptic qualities.
- U.S. Pat. No. 4,935,243 to Borkan, et al. discloses a chewable gelatin capsule composition that comprises less than about 30%, and preferably comprises about 20-26% water, and is directed to the use of a hydrogenated starch hydrolysate, which allowed a lower than expected end water content.
- U.S. Pat. No. 4,532,126 to Ebert, et al. discloses examples of soft gelatin capsules formed at as high as 37% water content, but specifies that these capsules were then subsequently dried to some undisclosed final end water content, in order to obtain desired chewing characteristics.
- U.S. Pat. No. 3,851,051 to Miskel et al. discloses numerous embodiments of a soft gelatin capsule that has an initial capsule shell water content of between 28.3 and 36.6%, but further discloses that the capsules are then dried to be in equilibrium with the internal gel-lattice composition, which has a water content of 15-20%.
- capsules are fabricated from a wet mass that is initially as much as 30% water by weight, but is then subsequently dried to 6%-8% water.
- the exemplary embodiments of the present invention relate to chewable softgel capsules suitable for encasing orally ingested articles, and to processes for producing such chewable softgel capsules.
- An exemplary embodiment of the present invention relates to a chewable soft capsule having an outer shell composition
- an outer shell composition comprising at least one gelatin in an amount selected from the range of 20% to 60% of the total weight of the shell composition, at least one plasticizer in an amount selected to render flexible said outer shell composition, an anti-tacking and softening agent in an amount selected to render said outer shell composition non-sticky and soft, and water.
- the outer shell composition of the chewable softgel capsule may optionally comprise at least one starch in an amount selected from the range of 0.1% to 35% of the total weight of the shell composition.
- the gelatin is selected from the group consisting of an animal-derived gelatin, a chemically modified gelatin, a physically modified gelatin, and combinations thereof.
- the anti-tacking and softening agent is selected from the group consisting of lecithin, polysorbate, biologically derived waxes, chemically derived waxes, fats, oils and combinations thereof.
- the oil is selected from the group consisting of palm oil, coconut oil, vegetable oil, middle chain triglycerins and mixtures thereof.
- the plasticizer is selected from the group consisting of glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol special, propylene glycol, maltitol, sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante, triethyl citrate, tributyl citrate, 1-2-propylenglycol, natural gum, isomerized sugar, xylitol, polyglycerol, glucose syrups, glucose, sugar alcohol, and combinations thereof.
- the starch is selected from the group consisting of native starches, modified starches, polysaccharides, and combinations thereof.
- the outer shell composition of the chewable softgel capsule may optionally comprise at least one of a flavorant, a colorant, a preservative, and optionally, combinations thereof.
- Another exemplary embodiment of the present invention is relates to a process for making the chewable softgel capsules.
- the process generally comprises the steps of selecting a suitable amount of gelatin, selecting a suitable amount of plasticizer, selecting a suitable amount of starch, selecting a suitable amount of anti-tacking and softening agent, placing predetermined amounts of said selections into a cooking tank and adding a predetermined amount of water, mixing selections for at least 2 hours at 80-90° C., reducing the temperature of the mixture in the cooking tank to 55-65° C. until all air bubbles are removed from the mixture, transferring the mixture from the cooking tank to a machine configured for producing chewable softgel capsules from the mixture, and then producing chewable softgel capsules from the mixture with the machine.
- Some exemplary embodiments of the present invention relate to a chewable softgel capsule exhibiting extended storage stability, a soft chewing texture and low stickiness. Further, the chewable softgel capsule exhibits excellent manufacturing properties and can be produced using conventional encapsulation machinery known in the art.
- Some exemplary embodiments of the present invention relate to a chewable softgel capsule encasing an orally ingestible article, where the capsule having an outer shell composition comprising: at least one gelatin; at least one plasticizer in an amount sufficient to render the outer shell flexible; at least one starch; an anti-tacking and softening agent sufficient to render said outer shell non-sticky during manufacturing processes; and purified water.
- the capsule outer shell may optionally further include at least one of flavorants, colorants, and preservatives.
- the chewable softgel capsule of the present invention may be produced by mixing an anti-tacking and softening agent, for example lecithin and or beeswax, with gelatin, plasticizer, and starch.
- the softgel capsules produced from this mixture are non-sticky at a high moisture content of about 20% thereby facilitating their processing and production.
- the softgel capsule remains very soft and pliable, even at low moisture contents of about 3%.
- the softgel capsules remain non-sticky and soft during extended storage, for example, in conditions of 40° C., 75% RH.
- the composition of the present chewable softgel capsule utilizes the starch component, when mixed with the gelatin and plasticizer, to form a matrix in which the anti-tacking and softening agent is trapped so as to produce the chewable softgel capsule of the present invention.
- the starch does not act as a moisture retention agent as understood in the prior art.
- This anti-tacking and softening agent when used in the formulations disclosed by the present invention enables the production of a softgel capsule which: is non-sticky under storage conditions of high temperature and humidity for example, 40° C., 75% RH; and is non-sticky and soft at both low e.g. 3%, and high e.g. 24%, capsule moisture content.
- Some exemplary embodiments of the present invention related to a softgel capsule encasing an orally ingestible article, the capsule having an outer shell composition comprising at least (a) at least one gelatin, preferably between about 20 to 60% weight, more preferably between about 20 to 50% weight, even more preferably between about 30 to 47% weight; (b) at least one plasticizer in an amount sufficient to render said outer shell flexible, preferably between about 25 to 45% weight; (c) an anti-tacking and softening agent sufficient to render the outer shell non-sticky and soft, preferably 0.2 to 15% weight, more preferably between about 0.4 to 10% weight, even more preferably 0.6 to 5% weight; and (d) purified water, preferably between about 3 to 25% weight, more preferably between about 3 to 20% weight.
- an outer shell composition comprising at least (a) at least one gelatin, preferably between about 20 to 60% weight, more preferably between about 20 to 50% weight, even more preferably between about 30 to 47% weight; (b) at least one plasticizer in an amount
- the capsule outer shell further includes (e) at least one starch, preferably between about 0.1 to 35% weight, more preferably between about 2 to 25% weight, even more preferably between about 10 to 20% weight.
- the capsule outer shell may optionally further include (f) at least one of flavorants, colorants, and preservatives.
- Some exemplary embodiments of the present invention relate to at least one plasticizer selected from the group consisting of glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol special, propylene glycol, maltitol, sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante, triethyl citrate, tributyl citrate, 1-2-propylenglycol, natural gum, isomerized sugar, xylitol, polyglycerol, glucose syrups, glucose, sugar alcohol, and combinations thereof.
- plasticizer selected from the group consisting of glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol special, propylene glycol, maltitol, sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante, triethyl citrate, tributyl citrate, 1-2-propy
- Some exemplary embodiments of the present invention relate to at least one gelatin selected from the group consisting of animal-derived gelatin, chemically modified gelatin, physically modified gelatin, and combinations thereof.
- a particularly suitable animal-derived gelatin may be derived from pigskin or alternatively bovine bone.
- Some exemplary embodiments of the present invention relate to incorporation into the present chewable soft gelatin capsule composition of at least one starch exemplified by native starches and modified starches.
- Suitable native starches are exemplified by potato starches, corn starches, wheat starches, oat starch, barley starch, rice starches, sorghum starches, and tapioca starches.
- Modified starches are native starches that have been partially degraded by physical treatments or alternatively, by chemical treatments, and are commonly referred to as physically modified starches and chemically modified starches.
- Suitable physical treatments are exemplified by pre-gelatinization and by heat-moisture treatments.
- Suitable physically modified starches are exemplified by physically modified potato starches, physically modified corn starches, physically modified wheat starches, physically modified oat starch, physically modified barley starch, physically modified rice starches, physically modified sorghum starches, and physically modified tapioca starches.
- Suitable chemical treatments are exemplified by alkali washes, washes with inorganic acids, enzymatic hydrolysis, bleaching, oxidation, esterification, etherification, cross-linking, ionization, and combinations of these modifications such as acetylation and oxidation.
- Suitable chemically modified starches are exemplified by esterified starch, starch phosphate, etherified starches, cross-linked starches, cationized starches, enzymatically digested starches, oxidized starches, and combinations thereof.
- Some exemplary embodiments of the present invention relate to a softgel capsule where the anti-tacking and softening agent is preferably between about 0.2 to 15% weight, more preferably between about 0.4 to 10% weight, and even more preferably between about 0.6 to 5% weight.
- Some exemplary embodiments of the present invention relate to an anti-tacking and softening agent selected from the group consisting of: lecithin, polysorbate such as Tween 60 or 80, biologically derived waxes, chemically derived waxes, fats, oils or combinations thereof.
- Some exemplary embodiments of the present invention relate to an anti-tacking and softening agent where it is preferably one of beeswax, lecithin, palm oil and coconut oil.
- Conventional softgel capsules known in the art were prepared according to the following method. A mixture of gelatin, glycerin, potato starch, stevia extract, orange flavor and water, in the proportions as indicated in Table 1 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity. The cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed. Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
- a mixture of gelatin, glycerin, potato starch, lecithin, stevia extract, orange flavor and water, in the proportions as indicated in Table 2 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity.
- the cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed.
- Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
- a mixture of gelatin, glycerin, potato starch, palm oil, aspartame, acesulfame-K, orange flavor and water, in the proportions as indicated in Table 3 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity.
- the cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed.
- Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with multi-vitamins paste.
- a mixture of gelatin, glycerin, potato starch, beeswax, stevia extract, mango flavor and water, in the proportions as indicated in Table 2 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity.
- the cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed.
- Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
- Each of the chewable soft capsules described in examples 1-4 were prepared and produced using the same methods. Two samples of the resulting capsules for each formulation were taken at a plurality of time points. These time points included: immediately after production (i.e. encapsulation); following 20-minutes of drying in a tumbler; after drying overnight in a room at 21° C., 23% room humidity (RH); and after drying in a room for three days at 21° C., 23% RH.
- the capsule samples for each time point and each formulation were packaged in glass bottles and sealed. Each sample comprised at least 86 soft capsules. A first set of samples was tested after being stored for a period of 2 weeks at 40° C. and 75% RH. A second set of samples was tested after being stored for a period of 12 months at 25° C. and 35% RH.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Nutrition Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
- This application is a continuation of application Ser. No. 12/537,092 filed Aug. 6, 2009, which is a continuation-in-part of application Ser. No. 12/200,850 filed Aug. 28, 2008 currently pending.
- The present invention relates generally to soft gelatin capsules and in particular, to soft gelatin capsules having a chewable consistency.
- Common routes for the administration of pharmacologically active agents, nutraceuticals, and vitamins are exemplified by a variety of oral dosage forms such as tablets, pills, and capsules. Additionally, a wide range of foodstuffs and oral hygiene products, such as breath fresheners are also orally dispensed. Such dosage forms are generally convenient, stable in storage and transport, and familiar to the user. However, they are not without problems, and these problems are often significant. It is extremely difficult for most people to swallow any of these oral dosage forms without supplemental water. It is frequently inconvenient or messy to have to take supplementary water with oral medicaments. Such difficulties are compounded for those with swallowing difficulties such as, for example, children and the elderly. Certain medical conditions, such as Parkinsons' disease and other neurological states, make it difficult to swallow oral dosage forms, even with supplemental water.
- Children and the elderly often experience difficulty in swallowing and ingesting medicines in solid forms such as tablets, pills, and capsules. Pharmaceuticals in forms which permit easy ingestion and whose active components are rapidly released in the oral cavity are desirable in the event of a medical emergency such as an attack of angina pectoris.
- Recently, with diversification of personal preferences in food and textures of food within the mouth, the texture of oral dosage forms of pharmaceuticals is an additional complication in oral medicaments.
- In conventional soft gelatin capsules, ingredients are encapsulated in a gelatin shell for consumption. Generally, the shell of a soft gelatin capsule comprises gelatin and a plasticizer to control the softness and flexibility of the shell. The shell further includes water and optionally other additives such as flavorants. The shells are typically dried until the water content is decreased to a certain level so as to prevent the capsule from being deformed or becoming undesirably sticky.
- Conventional soft gelatin capsules commonly available are often hard and tough because they are designed to dissolve after reaching the intestines so as to release their contents therein. Such capsules are not easily broken by teeth and are not suitable for chewing. In addition, twisting the capsule with the fingers to open the capsule is often a difficult practice, and generally opening the capsule requires a tool such as scissors. One measure to soften a soft gelatin capsule is to increase the plasticizer content and increase the capsule flexibility. However, this often makes a soft gelatin capsule more likely to stick to another soft gelatin capsule or to a container, thereby causing deterioration in storage stability. Increasing plasticizer content is further problematic in high-temperature, high-humidity regions. Soft gelatin capsules with acceptable dosing, stability, and storage and handling characteristics are typical when a relatively high gelatin content and a relatively low plasticizer and end water content is found in the capsules. However, the chewability, texture and mouth feel, and client acceptance of the capsules are found when a lower gelatin content and higher plasticizer and end water contents is used.
- Typically, chewable soft gelatin capsules, or chewable softgels, are designed such that the user chews upon the capsule to release the fill into the mouth instead of swallowing the capsule with the fill still encapsulated within the shell. Furthermore, these chewable softgels are intended to be completely or nearly completely dissolved by chewing. Such capsules are distinguished by particular fabrication problems, such as excessive stickiness during encapsulation and sticking of the end product to other capsules during post-encapsulation handling. Further, chewable softgels with high end water content typically have poor storage performance, sticking to one another in packaging and often melting or leaking during storage. In addition to the effects of water content, chewability of capsules can be affected by the bloom strength and the melting points of the gelatin used. In general, gelatins of lower bloom strength and lower melting point have preferable organoleptic qualities.
- U.S. Pat. No. 4,935,243 to Borkan, et al. discloses a chewable gelatin capsule composition that comprises less than about 30%, and preferably comprises about 20-26% water, and is directed to the use of a hydrogenated starch hydrolysate, which allowed a lower than expected end water content. U.S. Pat. No. 4,532,126 to Ebert, et al. discloses examples of soft gelatin capsules formed at as high as 37% water content, but specifies that these capsules were then subsequently dried to some undisclosed final end water content, in order to obtain desired chewing characteristics.
- U.S. Pat. No. 3,851,051 to Miskel et al. discloses numerous embodiments of a soft gelatin capsule that has an initial capsule shell water content of between 28.3 and 36.6%, but further discloses that the capsules are then dried to be in equilibrium with the internal gel-lattice composition, which has a water content of 15-20%. In U.S. Pat. No. 6,258,380 to Overholt, capsules are fabricated from a wet mass that is initially as much as 30% water by weight, but is then subsequently dried to 6%-8% water.
- U.S. patent application Ser. No. 10/456,450 to Makino; accomplished a high degree of hydration using fish gelatin having a low sol-gel transition temperature, that is, a relatively low melting point. However, such formulations can be problematic when stored at high temperatures or high humidity. For example, it is very difficult to formulate a fish gelatin capsule that will be stable at a storage temperature above 35° C. Capsules made with such low melting point gelatins tend to become sticky during storage, and may even burst or melt, releasing their contents. On the other hand, it is known that mammalian gelatins, some of which have melting temperatures above 60° C., tend to be much more stable at higher storage temperatures, but too often have poorer organoleptic qualities.
- There is a need for chewable softgel compositions having commercially acceptable properties at the time the capsules are packaged and made available for sale. Additionally, these chewable capsules should exhibit stability under reasonably expected storage times and conditions. Further, these capsules need to exhibit a soft, pleasant chewing texture and low stickiness.
- The exemplary embodiments of the present invention relate to chewable softgel capsules suitable for encasing orally ingested articles, and to processes for producing such chewable softgel capsules.
- An exemplary embodiment of the present invention relates to a chewable soft capsule having an outer shell composition comprising at least one gelatin in an amount selected from the range of 20% to 60% of the total weight of the shell composition, at least one plasticizer in an amount selected to render flexible said outer shell composition, an anti-tacking and softening agent in an amount selected to render said outer shell composition non-sticky and soft, and water.
- According to one aspect the outer shell composition of the chewable softgel capsule may optionally comprise at least one starch in an amount selected from the range of 0.1% to 35% of the total weight of the shell composition.
- According to one aspect, the gelatin is selected from the group consisting of an animal-derived gelatin, a chemically modified gelatin, a physically modified gelatin, and combinations thereof.
- According to another aspect, the anti-tacking and softening agent is selected from the group consisting of lecithin, polysorbate, biologically derived waxes, chemically derived waxes, fats, oils and combinations thereof.
- According to another aspect, the oil is selected from the group consisting of palm oil, coconut oil, vegetable oil, middle chain triglycerins and mixtures thereof.
- According to yet another aspect, the plasticizer is selected from the group consisting of glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol special, propylene glycol, maltitol, sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante, triethyl citrate, tributyl citrate, 1-2-propylenglycol, natural gum, isomerized sugar, xylitol, polyglycerol, glucose syrups, glucose, sugar alcohol, and combinations thereof.
- According to a further aspect, the starch is selected from the group consisting of native starches, modified starches, polysaccharides, and combinations thereof.
- According to another further aspect, the outer shell composition of the chewable softgel capsule may optionally comprise at least one of a flavorant, a colorant, a preservative, and optionally, combinations thereof.
- Another exemplary embodiment of the present invention is relates to a process for making the chewable softgel capsules. The process generally comprises the steps of selecting a suitable amount of gelatin, selecting a suitable amount of plasticizer, selecting a suitable amount of starch, selecting a suitable amount of anti-tacking and softening agent, placing predetermined amounts of said selections into a cooking tank and adding a predetermined amount of water, mixing selections for at least 2 hours at 80-90° C., reducing the temperature of the mixture in the cooking tank to 55-65° C. until all air bubbles are removed from the mixture, transferring the mixture from the cooking tank to a machine configured for producing chewable softgel capsules from the mixture, and then producing chewable softgel capsules from the mixture with the machine.
- Some exemplary embodiments of the present invention relate to a chewable softgel capsule exhibiting extended storage stability, a soft chewing texture and low stickiness. Further, the chewable softgel capsule exhibits excellent manufacturing properties and can be produced using conventional encapsulation machinery known in the art.
- Some exemplary embodiments of the present invention relate to a chewable softgel capsule encasing an orally ingestible article, where the capsule having an outer shell composition comprising: at least one gelatin; at least one plasticizer in an amount sufficient to render the outer shell flexible; at least one starch; an anti-tacking and softening agent sufficient to render said outer shell non-sticky during manufacturing processes; and purified water. The capsule outer shell may optionally further include at least one of flavorants, colorants, and preservatives.
- Surprisingly, it has been found that the chewable softgel capsule of the present invention may be produced by mixing an anti-tacking and softening agent, for example lecithin and or beeswax, with gelatin, plasticizer, and starch. The softgel capsules produced from this mixture are non-sticky at a high moisture content of about 20% thereby facilitating their processing and production. In addition, the softgel capsule remains very soft and pliable, even at low moisture contents of about 3%. Moreover, the softgel capsules remain non-sticky and soft during extended storage, for example, in conditions of 40° C., 75% RH.
- The composition of the present chewable softgel capsule utilizes the starch component, when mixed with the gelatin and plasticizer, to form a matrix in which the anti-tacking and softening agent is trapped so as to produce the chewable softgel capsule of the present invention. The starch does not act as a moisture retention agent as understood in the prior art. This anti-tacking and softening agent when used in the formulations disclosed by the present invention enables the production of a softgel capsule which: is non-sticky under storage conditions of high temperature and humidity for example, 40° C., 75% RH; and is non-sticky and soft at both low e.g. 3%, and high e.g. 24%, capsule moisture content.
- Some exemplary embodiments of the present invention related to a softgel capsule encasing an orally ingestible article, the capsule having an outer shell composition comprising at least (a) at least one gelatin, preferably between about 20 to 60% weight, more preferably between about 20 to 50% weight, even more preferably between about 30 to 47% weight; (b) at least one plasticizer in an amount sufficient to render said outer shell flexible, preferably between about 25 to 45% weight; (c) an anti-tacking and softening agent sufficient to render the outer shell non-sticky and soft, preferably 0.2 to 15% weight, more preferably between about 0.4 to 10% weight, even more preferably 0.6 to 5% weight; and (d) purified water, preferably between about 3 to 25% weight, more preferably between about 3 to 20% weight. The capsule outer shell further includes (e) at least one starch, preferably between about 0.1 to 35% weight, more preferably between about 2 to 25% weight, even more preferably between about 10 to 20% weight. The capsule outer shell may optionally further include (f) at least one of flavorants, colorants, and preservatives.
- Some exemplary embodiments of the present invention relate to at least one plasticizer selected from the group consisting of glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol special, propylene glycol, maltitol, sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante, triethyl citrate, tributyl citrate, 1-2-propylenglycol, natural gum, isomerized sugar, xylitol, polyglycerol, glucose syrups, glucose, sugar alcohol, and combinations thereof.
- Some exemplary embodiments of the present invention relate to at least one gelatin selected from the group consisting of animal-derived gelatin, chemically modified gelatin, physically modified gelatin, and combinations thereof. A particularly suitable animal-derived gelatin may be derived from pigskin or alternatively bovine bone.
- Some exemplary embodiments of the present invention relate to incorporation into the present chewable soft gelatin capsule composition of at least one starch exemplified by native starches and modified starches. Suitable native starches are exemplified by potato starches, corn starches, wheat starches, oat starch, barley starch, rice starches, sorghum starches, and tapioca starches. Modified starches are native starches that have been partially degraded by physical treatments or alternatively, by chemical treatments, and are commonly referred to as physically modified starches and chemically modified starches.
- Suitable physical treatments are exemplified by pre-gelatinization and by heat-moisture treatments. Suitable physically modified starches are exemplified by physically modified potato starches, physically modified corn starches, physically modified wheat starches, physically modified oat starch, physically modified barley starch, physically modified rice starches, physically modified sorghum starches, and physically modified tapioca starches.
- Suitable chemical treatments are exemplified by alkali washes, washes with inorganic acids, enzymatic hydrolysis, bleaching, oxidation, esterification, etherification, cross-linking, ionization, and combinations of these modifications such as acetylation and oxidation. Suitable chemically modified starches are exemplified by esterified starch, starch phosphate, etherified starches, cross-linked starches, cationized starches, enzymatically digested starches, oxidized starches, and combinations thereof.
- Some exemplary embodiments of the present invention relate to a softgel capsule where the anti-tacking and softening agent is preferably between about 0.2 to 15% weight, more preferably between about 0.4 to 10% weight, and even more preferably between about 0.6 to 5% weight.
- Some exemplary embodiments of the present invention relate to an anti-tacking and softening agent selected from the group consisting of: lecithin, polysorbate such as Tween 60 or 80, biologically derived waxes, chemically derived waxes, fats, oils or combinations thereof.
- Some exemplary embodiments of the present invention relate to an anti-tacking and softening agent where it is preferably one of beeswax, lecithin, palm oil and coconut oil.
- The following Examples illustrate practical formulations of chewable softgel capsules of the present invention. It is to be understood these examples should not be considered as limitations, the experimental data is only for illustration.
- Conventional softgel capsules known in the art were prepared according to the following method. A mixture of gelatin, glycerin, potato starch, stevia extract, orange flavor and water, in the proportions as indicated in Table 1 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity. The cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed. Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
-
TABLE 1 Item Name % weight Gelatin 170-180 Bloom Pigskin 33.58 Glycerin 99.5% 28.79 Potato Starch 11.5 Stevia extract 0.0144 Orange Flavor 0.191 Purified Water 26.0
Exemplary embodiments of the softgel capsules of the present invention disclosed above are detailed in Examples 2-4 below. - A mixture of gelatin, glycerin, potato starch, lecithin, stevia extract, orange flavor and water, in the proportions as indicated in Table 2 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity. The cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed. Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
-
TABLE 2 Item Name % weight Gelatin 170-180 Bloom Pigskin 33.58 Glycerin 99.5% 28.79 Potato Starch 11.5 Lecithin 0.96 Stevia extract 0.0144 Orange Flavor 0.191 Purified Water 24.96 - A mixture of gelatin, glycerin, potato starch, palm oil, aspartame, acesulfame-K, orange flavor and water, in the proportions as indicated in Table 3 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity. The cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed. Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with multi-vitamins paste.
-
TABLE 3 Item Name % weight Gelatin 170-180 Bloom Pigskin 34 Glycerin 99.5% 28 Potato Starch 10.0 Palm Oil 1.5 Aspartame 0.190 Acesulfame-K 0.199 Orange Flavor 0.191 Purified Water 25.92 - A mixture of gelatin, glycerin, potato starch, beeswax, stevia extract, mango flavor and water, in the proportions as indicated in Table 2 below, up to a weight of 200 kg were placed in a cooking tank with 800 L of capacity. The cooking tank was heated to 80-90° C. and the temperature was maintained for a period of 1-3 hours. The temperature of the cooking tank was then reduced to 55° C. until air bubbles were about completely removed. Chewable soft capsules of 20-oval size were produced using conventional soft capsule machinery and were filled with seal oil.
-
TABLE 4 Item Name % Gelatin 170-180 Bloom Pigskin 33 Glycerin 99.5% 26 Potato Starch 12 beewax 1.0 Stevia extract 0.0144 Mango Flavor 0.191 Purified Water 27.79 - Each of the chewable soft capsules described in examples 1-4 were prepared and produced using the same methods. Two samples of the resulting capsules for each formulation were taken at a plurality of time points. These time points included: immediately after production (i.e. encapsulation); following 20-minutes of drying in a tumbler; after drying overnight in a room at 21° C., 23% room humidity (RH); and after drying in a room for three days at 21° C., 23% RH. The capsule samples for each time point and each formulation were packaged in glass bottles and sealed. Each sample comprised at least 86 soft capsules. A first set of samples was tested after being stored for a period of 2 weeks at 40° C. and 75% RH. A second set of samples was tested after being stored for a period of 12 months at 25° C. and 35% RH.
- The results of the comparison of samples for each of the formulations taken at different time points and then stored under different conditions are shown in Table 5. The samples of the capsules at each time point had variable degrees of capsule shell moisture ranging from 3%-24%. Despite the variable in shell moisture content, each of the formulations (B, C, and D) of the present invention exhibited no stickiness and softness under either set of the storage conditions tested. However, the capsule from formulation A containing no anti-tacking and softening agent showed stickiness for each sample time-point tested under both sets of storage conditions. In addition, the capsule formulation A produced capsules which were significantly harder than the formulations of the present invention, especially when the shell moisture is lower than 11%. In Table 5, N represents no sticky, Y represents sticky, S represents soft, and H represents hard.
-
TABLE 5 Formulation A containing no anti-tacking and soften Formulation B Formulation C Formulation D agent % % % % Shell 12 Shell 12 Shell 12 Shell 12 Timepoints Moisture 2 weeks months Moisture 2 weeks months Moisture 2 weeks months Moisture 2 weeks months Sample 1 Immediately 22% NS NS 23% NS NS 24% NS NS 22% YS YS following production Sample 2 After drying 11% NS NS 11% NS NS 12% NS NS 11% YH YH for 30 mins in a tumbler Sample 3 After drying 6% NS NS 7% NS NS 7% NS NS 6% YH YH overnight 21° C., 23% RH Sample 4 After drying 3% NS NS 3% NS NS 4% NS NS 3% YH YH for 3 days 21° C., 23% RH - While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
Claims (12)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/543,435 US7662406B1 (en) | 2009-08-06 | 2009-08-18 | Chewable softgel capsules |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/537,092 US20100092548A1 (en) | 2008-08-28 | 2009-08-06 | Chewable softgel capsules |
US12/543,435 US7662406B1 (en) | 2009-08-06 | 2009-08-18 | Chewable softgel capsules |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/537,092 Continuation US20100092548A1 (en) | 2008-08-28 | 2009-08-06 | Chewable softgel capsules |
Publications (2)
Publication Number | Publication Date |
---|---|
US7662406B1 US7662406B1 (en) | 2010-02-16 |
US20100055174A1 true US20100055174A1 (en) | 2010-03-04 |
Family
ID=41665773
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/537,092 Abandoned US20100092548A1 (en) | 2008-08-28 | 2009-08-06 | Chewable softgel capsules |
US12/543,435 Active US7662406B1 (en) | 2009-08-06 | 2009-08-18 | Chewable softgel capsules |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/537,092 Abandoned US20100092548A1 (en) | 2008-08-28 | 2009-08-06 | Chewable softgel capsules |
Country Status (4)
Country | Link |
---|---|
US (2) | US20100092548A1 (en) |
EP (1) | EP2315534A4 (en) |
CA (1) | CA2707882C (en) |
WO (1) | WO2011014942A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2315534A1 (en) * | 2009-08-06 | 2011-05-04 | Viva Pharmaceuticals Inc. | Chewable softgel capsules |
JP2014516995A (en) * | 2011-06-10 | 2014-07-17 | ハンヂョウ・ヤンシェンタン・ヘルスケア・プロダクツ・カンパニー・リミテッド | Chewable soft capsule shell and chewable soft capsule |
JP2018076315A (en) * | 2016-11-02 | 2018-05-17 | 富士カプセル株式会社 | Soft capsule film |
KR20220068904A (en) * | 2020-11-19 | 2022-05-26 | (주)알피바이오 | Composition for animal-based chewable soft capsule and animal-based chewable soft capsule using the same |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8621764B2 (en) | 2011-03-16 | 2014-01-07 | John PUCKETT | Gelatin capsule formulation and drying system |
US10350296B1 (en) * | 2013-07-22 | 2019-07-16 | Aspire Pharmaceuticals | Chewable gelatin formulations |
US20200221752A1 (en) * | 2013-09-13 | 2020-07-16 | Phood Station | Encapsulated food products and methods of making same |
US20150209360A1 (en) * | 2014-01-30 | 2015-07-30 | Orbz, Llc | Oral caffeine delivery composition |
CN104622843B (en) * | 2015-01-07 | 2017-10-10 | 汤臣倍健股份有限公司 | A kind of flexible glue encapsulated gluing method |
WO2017070578A1 (en) * | 2015-10-21 | 2017-04-27 | The Regents Of The University Of Michigan | Detection and treatment of caries and microcavities with nanoparticles |
EP3456322A4 (en) * | 2016-05-11 | 2020-01-01 | Blanco Fernández, María Del Carmen | Single-dose container and method for manufacturing same |
CA3112541A1 (en) * | 2018-10-18 | 2020-04-23 | Johnson & Johnson Consumer Inc. | Novel dosage form |
US11707074B2 (en) | 2020-04-09 | 2023-07-25 | Kim Schwarz | Edible hydration pod and method of manufacturing an edible hydration pod |
CN111420065A (en) * | 2020-05-09 | 2020-07-17 | 李太适 | Mixed glue composition and preparation method thereof |
CN114632068A (en) * | 2020-12-16 | 2022-06-17 | 李振全 | Composition of chewing type capsule |
CN114767651B (en) * | 2022-03-07 | 2023-06-02 | 石家庄华加药用胶囊有限公司 | High-toughness hard plant hollow capsule and preparation method thereof |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2811483A (en) * | 1954-12-09 | 1957-10-29 | Pfizer & Co C | Pharmaceutical composition and process for preparing the same |
US4609403A (en) * | 1984-03-12 | 1986-09-02 | Warner-Lambert Company | Foam soft gelatin capsules and their method of manufacture |
US4935243A (en) * | 1988-12-19 | 1990-06-19 | Pharmacaps, Inc. | Chewable, edible soft gelatin capsule |
GB9313329D0 (en) * | 1993-06-28 | 1993-08-11 | Scherer Ltd R P | Softgel capsule shell compositions |
CA2165783C (en) * | 1993-06-28 | 2006-04-11 | Keith Graeme Hutchison | Soft gelatin capsule shell compositions |
CA2205553C (en) * | 1994-12-16 | 2009-04-07 | Warner-Lambert Company | Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process |
JP3261331B2 (en) * | 1997-03-31 | 2002-02-25 | 東海カプセル株式会社 | Soft capsule for chewing |
US6258380B1 (en) * | 1999-03-05 | 2001-07-10 | Banner Pharmacaps, Inc. | Chewable soft capsule |
US6949256B2 (en) * | 2002-01-18 | 2005-09-27 | Banner Pharmacaps, Inc. | Non-gelatin capsule shell formulation |
JP4226846B2 (en) * | 2002-06-07 | 2009-02-18 | キャタレント・ジャパン株式会社 | Soft capsule that can disintegrate in the oral cavity |
US20060233873A1 (en) * | 2003-01-24 | 2006-10-19 | Julien Meissonnier | Dispersion of taste masked crystals or granules of active substances, chewable soft capsules filled with said dispersion, and process for preparing same |
US9241902B2 (en) * | 2003-12-17 | 2016-01-26 | R.P. Scherer Technologies, Llc | Chewable soft capsules containing ungelatinized starch |
CA2677036A1 (en) | 2007-03-06 | 2008-09-12 | Bioriginal Food & Science Corp. | Soft gelatin capsule shells containing oil soluble flavoring and methods of making the same |
US20100092548A1 (en) * | 2008-08-28 | 2010-04-15 | Viva Pharmaceuticals Inc. | Chewable softgel capsules |
-
2009
- 2009-08-06 US US12/537,092 patent/US20100092548A1/en not_active Abandoned
- 2009-08-18 US US12/543,435 patent/US7662406B1/en active Active
-
2010
- 2010-04-27 CA CA2707882A patent/CA2707882C/en active Active
- 2010-04-27 EP EP10760206A patent/EP2315534A4/en not_active Withdrawn
- 2010-04-27 WO PCT/CA2010/000788 patent/WO2011014942A1/en active Application Filing
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2315534A1 (en) * | 2009-08-06 | 2011-05-04 | Viva Pharmaceuticals Inc. | Chewable softgel capsules |
EP2315534A4 (en) * | 2009-08-06 | 2011-08-31 | Viva Pharmaceutical Inc | Chewable softgel capsules |
JP2014516995A (en) * | 2011-06-10 | 2014-07-17 | ハンヂョウ・ヤンシェンタン・ヘルスケア・プロダクツ・カンパニー・リミテッド | Chewable soft capsule shell and chewable soft capsule |
US9232810B2 (en) | 2011-06-10 | 2016-01-12 | Hangzhou Yangshengtang Healthcare Products Co., Ltd. | Chewable soft capsule shell and chewable soft capsule |
JP2018076315A (en) * | 2016-11-02 | 2018-05-17 | 富士カプセル株式会社 | Soft capsule film |
KR20220068904A (en) * | 2020-11-19 | 2022-05-26 | (주)알피바이오 | Composition for animal-based chewable soft capsule and animal-based chewable soft capsule using the same |
KR102523186B1 (en) | 2020-11-19 | 2023-04-18 | (주)알피바이오 | Composition for animal-based chewable soft capsule and animal-based chewable soft capsule using the same |
Also Published As
Publication number | Publication date |
---|---|
EP2315534A4 (en) | 2011-08-31 |
WO2011014942A1 (en) | 2011-02-10 |
US7662406B1 (en) | 2010-02-16 |
CA2707882A1 (en) | 2010-09-22 |
EP2315534A1 (en) | 2011-05-04 |
US20100092548A1 (en) | 2010-04-15 |
CA2707882C (en) | 2012-04-03 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US7662406B1 (en) | Chewable softgel capsules | |
ES2367076T3 (en) | SEALED COMPOSITE PACKS OF EDIBLE FILM STRIPS AND MANUFACTURING AND USING PROCEDURES OF THE SAME. | |
US20100055175A1 (en) | Soft gelatin capsule shells containing oil soluble flavoring and methods of making the same | |
US6582727B2 (en) | Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same | |
US6280767B1 (en) | Soft gelatin capsule | |
JP4971298B2 (en) | Enteric / sustained release soft capsule and method for producing the same | |
JPH08511795A (en) | Soft gelatin capsule shell composition | |
MXPA05000280A (en) | Chewable soft capsule. | |
JP4790629B2 (en) | Chewable soft capsules containing non-gelatinized starch | |
US20240130977A1 (en) | Orally available articles containing at least one stabilized supplement therein | |
KR100732199B1 (en) | Masticatable capsule and process for producing the same | |
US11793761B2 (en) | Soft gel capsule preparations | |
KR102438852B1 (en) | Chewable soft capsule composition in gummy jelly form |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: VIVA PHARMACEUTICAL INC.,CANADA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:XIE, XUEJU;KO, YU-LUNG;KO, CHIEN-KUANG;AND OTHERS;REEL/FRAME:023723/0371 Effective date: 20090818 |
|
STCF | Information on status: patent grant |
Free format text: PATENTED CASE |
|
FPAY | Fee payment |
Year of fee payment: 4 |
|
FPAY | Fee payment |
Year of fee payment: 8 |
|
MAFP | Maintenance fee payment |
Free format text: PAYMENT OF MAINTENANCE FEE, 12TH YR, SMALL ENTITY (ORIGINAL EVENT CODE: M2553); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY Year of fee payment: 12 |