AU2021101281A4 - Orally-administered dosage form and method of producing the same - Google Patents

Orally-administered dosage form and method of producing the same Download PDF

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Publication number
AU2021101281A4
AU2021101281A4 AU2021101281A AU2021101281A AU2021101281A4 AU 2021101281 A4 AU2021101281 A4 AU 2021101281A4 AU 2021101281 A AU2021101281 A AU 2021101281A AU 2021101281 A AU2021101281 A AU 2021101281A AU 2021101281 A4 AU2021101281 A4 AU 2021101281A4
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AU
Australia
Prior art keywords
composition
capsule
orally
dosage form
outer capsule
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AU2021101281A
Inventor
Paul Ly
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Perday's Health Function Food Co Ltd
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Perdays Health Function Food Co Ltd
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Priority to AU2021101281A priority Critical patent/AU2021101281A4/en
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Assigned to PERDAY'S HEALTH FUNCTION FOOD CO., LIMITED reassignment PERDAY'S HEALTH FUNCTION FOOD CO., LIMITED Request to Amend Deed and Register Assignors: PERDAY'S HEALTH FUNCTIONAL FOOD CO., LIMITED
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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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

There is disclosed a method of producing an orally-administered dosage form, the method comprising: preparing a first composition; preparing a second composition; encapsulating the first composition into an inner capsule; and encapsulating the second composition and the inner capsule into an outer capsule and thereby forming a headspace in the outer capsule, wherein the headspace comprises a substantially inert gas. 1/2 100 200 Preparation of a first dry Preparation of a second liquid composition composition Encapsulation of the first dry -300 composition into an inner capsule Encapsulation of the second liquid composition and the inner capsule 00 into an outer capsule Band sealing the outer capsule I 500 Fig. 1

Description

1/2
100 200
Preparation of a first dry Preparation of a second liquid composition composition
Encapsulation of the first dry -300 composition into an inner capsule
Encapsulation of the second liquid composition and the inner capsule 00 into an outer capsule
Band sealing the outer capsule I 500
Fig. 1
Orally-administered dosage form and method of producing the same
Technical Field
[0001] The present disclosure relates to an orally-administered dosage form and a method of producing the orally administered form.
Background
[0002] Health supplements are typically orally consumed by a person so that the active ingredients are absorbed during digestion. However, certain ingredients are more efficiently absorbed at different stages of the digestive process. For example, certain vitamins are more efficiently absorbed in the stomach, whereas probiotics are more efficiently absorbed in the intestines.
[0003] In order to administer at least two different active ingredients in a supplement, a multi-layered tablet has been developed with each layer comprising an active ingredient. Upon consumption by a person, each layer would be designed to release its active ingredient at different stages of the digestive process.
[0004] Whilst the multi-layered tablet allows for more efficient absorption of at least two active ingredients, the multi-layered tablet cannot be utilised to administer liquid active ingredients. Further, it is often difficult to utilise the bi-layer tablet to administer probiotics as the compression of the probiotics during the manufacture of the tablet may impact its viability. Furthermore, the active ingredients in a multi-layered tablet are often prone to oxidation, which reduces the effectiveness and shelf-life of the same.
Object
[0005] It is an object of the present disclosure to substantially overcome or ameliorate one or more of the above disadvantages, or at least provide a useful alternative.
Summary
[0006] In accordance with an aspect of the present disclosure, there is provided a method of producing an orally-administered dosage form, the method comprising: preparing a first composition; preparing a second composition; encapsulating the first composition into an inner capsule; and encapsulating the second composition and the inner capsule into an outer capsule and thereby forming a headspace in the outer capsule, wherein the headspace comprises a substantially inert gas.
[0007] The substantially inert gas may comprise nitrogen.
[0008] The method may further comprise band sealing the outer capsule.
[0009] The first composition may be a dry composition comprising one or more of minerals, vitamins, herbal ingredients, probiotics, maltodextrin, microcrystalline cellulose, silicon dioxide, gum acacia, magnesium stearate, trehalose, croscarmellose sodium, crospovidone, calcium hydrogen phosphate, pectin, and fructose oligosaccharide. Further, the second composition may be a liquid composition comprising one or more of fish oil, docosahexaenoic acid (DHA) oil, omega oil, medium chain triglycerides, mixed tocopherol, minerals, vitamins, herbal ingredients, silicon dioxide, and silica colloidal anhydrous.
[0010] In accordance with another aspect of the present disclosure, there is provided an orally-administrated dosage form produced by the method as described above.
Brief Description of Drawings
[0011] An embodiment of the present disclosure will now be described hereinafter, byway of example only, with reference to the accompanying drawings, wherein:
[0012] Fig. 1 is a flow diagram showing an embodiment of a method of producing an orally administered dosage form; and
[0013] Fig. 2 is a perspective view of a capsule produced by the method of Fig. 1.
Description of Embodiments
[0014] Fig. 1 shows a method of producing an orally-administered dosage form according to an embodiment of the present disclosure. In this embodiment, as shown in Fig. 2, the orally administered dosage form is in the form of a health/dietary supplement capsule 10 for delivering dry and liquid compositions to a person. It will be appreciated, however, that the capsule 10 may be utilised for other purposes (e.g., pharmaceutical).
[0015] At step 100, a first dry composition is prepared by mixing solid components together in a dry blender. In this embodiment, the solid components include 5-95% by weight of actives and 10-95% by weight of excipients. The actives include one or more of minerals, vitamins, herbal ingredients, probiotics and fructose oligosaccharide. The excipients include one or more of maltodextrin, microcrystalline cellulose, silicon dioxide, gum acacia, magnesium stearate, trehalose, croscarmellose sodium, crospovidone, calcium hydrogen phosphate and pectin. The mixing process is conducted for 30-60 minutes at 5-20 RPM or until the first composition is homogenous. The mixing is also conducted in a controlled environment at 10-30°C and 15-50% relative humidity. After this mixing process, the first composition is stored in a dry holding tank.
[0016] At step 200, the second liquid composition is prepared by mixing oil components, solid components and viscosity enhances. The oil components make up about 40-80% by weight of the second composition and include one or more of fish oil, docosahexaenoic acid (DHA) oil, omega oil, algal oil, medium chain triglycerides and mixed tocopherol. The solid components make up 0-10% by weight of the second composition and include one or more of minerals, vitamins and herbal ingredients. The viscosity enhancers make up about 14% by weight of the second composition and include one or more of silicon dioxide and silica colloidal anhydrous. The mixing process is conducted for 30-60 minutes or until the second composition is homogenous, and the viscosity of the second composition is maintained between 50-200cps. After this mixing process, the second composition is stored in a liquid holding tank.
[0017] In this embodiment, steps 100 and 200 are carried out simultaneously. However, in other embodiments, it will be appreciated that steps 100 and 200 may be carried out one after the other.
[0018] At step 300, the first composition is encapsulated in a hard shell inner capsule 20. The inner capsule 20 may be in the form of a size #4 normal release capsule or modified/delayed release capsule, depending on when the first composition needs to be released in the digestive system. The inner capsule 20 comprises a body 20a and a cap 20b that is lockable with the body 20a to close the inner capsule 20. It will be generally understood that the cap 20b of the inner capsule 20 has 2 to 6 dimples that are engaged with a corresponding recessed ring on the body 20a of the inner capsule 20 to lock the cap 20b to the body 20a. Also, the inner capsule 20 is formed from one or more of the following ingredients: Hypromellose, gelatin, carrageenan, potassium acetate, colourants and purified water.
[0019] Instep 300, the first composition from the dry holding tank is inserted into the body a of the inner capsule 20. Then, the cap 20b of the inner capsule 20 is locked to the body a such that the first composition is encapsulated therein.
[0020] At step 400, the second composition and the inner capsule 20 (with the first composition encapsulated therein) are encapsulated in a hard shell outer capsule 30. The outer capsule 30 may be in the form of a size #0 normal release capsule. Similar to the inner capsule , the outer capsule 30 comprises a body 30a and a cap 30b that is lockable with the body a to close the outer capsule 30. The cap 30b and the body 30a of the outer capsule 30 lock in the same manner as described above in relation to the inner capsule 20. Also, the outer capsules 30 is formed from the same ingredient(s) as the inner capsule 20.
[0021] Instep 400, the second composition from the liquid holding tank is initially inserted into the body 30a of the outer capsule 30. Then, the inner capsule 20 is inserted into the body a of the outer capsule 30 with the second composition. Then, the cap 30b of the outer capsule 30 is locked to the body 30a such that the second composition and the inner capsule are encapsulated therein. In this embodiment, prior to the second composition being inserted into the outer capsule 30, the environment around the second composition is constantly purged with nitrogen to minimise the risk of oxidation. Additionally, the cap 30b and the body 30a of the outer capsule 30 are locked in an environment that is also constantly purged with nitrogen such that a headspace formed in the outer capsule 30 is substantially comprised of nitrogen. The headspace is approximately 0.05-0.2 ml.
[0022] In other embodiments, the nitrogen may be replaced with another substantially inert gas, such as helium, or an inert gas, such as argon.
[0023] At step 500, the outer capsule 30 is band sealed. Specifically, a band sealing solution is applied along the joint between the body 30a and the cap 30b of the outer capsule 30. Then, the outer capsule 30 is dried by using hot air at approximately 30-55°C such that the outer capsule 30 is hermetically sealed. The band sealing solution comprises one or more of the following ingredients: Hypromellose, gelatin, colourants, purified water, isopropyl alcohol, and ethyl alcohol.
[0024] According to the above-described embodiment, the produced capsule 10 composed of the inner 20 and outer capsules 30 allows the first composition to be released at the same or different time to the second composition, depending on whether the inner capsule 20 is a normal release or modified/delayed release capsule. Further, one of the produced capsules 10 is able to administer liquid active ingredients with dry active ingredients. Further, band sealing allows the outer capsule 30 to be a hard shell (rather than a soft gel) and contain a liquid composition. This reduces the overall cost of manufacturing. Further, as the first composition does not need to be compressed in any stage of the described method, the viability of the first composition (especially when comprising probiotics) is not impacted. Further, as the headspace in the outer capsule 30 is substantially comprised of nitrogen, oxidation of the second composition (especially when comprising fish oil, omega oil and/or algal oil) is substantially minimised. Furthermore, as the second composition and the headspace (comprised of nitrogen) surround the inner capsule 20, oxidation of the first composition in the inner capsule 20 is also substantially minimised.
[0025] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiment, without departing from the broad general scope of the present disclosure. The above-described embodiment is, therefore, to be considered in all respects as illustrative and not restrictive.

Claims (5)

CLAIMS:
1. A method of producing an orally-administered dosage form, the method comprising: preparing a first composition; preparing a second composition; encapsulating the first composition into an inner capsule; and encapsulating the second composition and the inner capsule into an outer capsule and thereby forming a headspace in the outer capsule, wherein the headspace comprises a substantially inert gas.
2. The method of claim 1, wherein the substantially inert gas comprises nitrogen.
3. The method of claim 1 or 2, further comprising band sealing the outer capsule.
4. The method of any one of the preceding claims, wherein the first composition is a dry composition comprising one or more of minerals, vitamins, herbal ingredients, probiotics, maltodextrin, microcrystalline cellulose, silicon dioxide, gum acacia, magnesium stearate, trehalose, croscarmellose sodium, crospovidone, calcium hydrogen phosphate, pectin, and fructose oligosaccharide, and wherein the second composition is a liquid composition comprising one or more of fish oil, docosahexaenoic acid (DHA) oil, omega oil, medium chain triglycerides, mixed tocopherol, minerals, vitamins, herbal ingredients, silicon dioxide, and silica colloidal anhydrous.
5. An orally-administrated dosage form produced by the method of any one of the preceding claims.
AU2021101281A 2021-03-12 2021-03-12 Orally-administered dosage form and method of producing the same Active AU2021101281A4 (en)

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Application Number Priority Date Filing Date Title
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Owner name: PERDAY'S HEALTH FUNCTION FOOD CO., LIMITED

Free format text: FORMER NAME(S): PERDAY'S HEALTH FUNCTIONAL FOOD CO., LIMITED