[go: up one dir, main page]

WO2025004062A1 - Procédé de conditionnement d'une surface d'une première partie d'une capsule - Google Patents

Procédé de conditionnement d'une surface d'une première partie d'une capsule Download PDF

Info

Publication number
WO2025004062A1
WO2025004062A1 PCT/IN2024/050511 IN2024050511W WO2025004062A1 WO 2025004062 A1 WO2025004062 A1 WO 2025004062A1 IN 2024050511 W IN2024050511 W IN 2024050511W WO 2025004062 A1 WO2025004062 A1 WO 2025004062A1
Authority
WO
WIPO (PCT)
Prior art keywords
sealant
capsule
conditioning
dosing
dosing head
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.)
Pending
Application number
PCT/IN2024/050511
Other languages
English (en)
Inventor
Karan Singh
Werner Bongers
Tobias Johan LOUW
Horst Wolfgang Friedrich VON LENGELING
Duncan Miller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SCI-TECH CENTRE
Vantage Nutrition LLP
Combocap Inc
Original Assignee
SCI-TECH CENTRE
Vantage Nutrition LLP
Combocap Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by SCI-TECH CENTRE, Vantage Nutrition LLP, Combocap Inc filed Critical SCI-TECH CENTRE
Publication of WO2025004062A1 publication Critical patent/WO2025004062A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
    • B65B51/02—Applying adhesives or sealing liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
    • B65B7/28—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons by applying separate preformed closures, e.g. lids, covers
    • B65B7/2842—Securing closures on containers
    • B65B7/2871—Securing closures on containers by gluing

Definitions

  • the present disclosure generally relates to methods of capsule manufacturing, and more particularly, the present disclosure relates to a method for conditioning a surface of a first portion of a capsule.
  • Capsules are used for holding ingredients in a sealed environment, thereby protecting the ingredients therein.
  • Capsules are known to be of two types, namely, hard capsules, and soft gel capsules.
  • the soft gel capsules are manufactured by making a soft gel layer using a hot layer and a soft capsule layer. The soft gel layer is pressed over a dosage form and then sealed to deliver an encapsulated dosage.
  • the hard capsules have a strong structure and are suitable for high- volume and high-speed production.
  • the hard capsules are, generally, separately filled and then closed, thereby allowing for secure holding of ingredients in the enclosed environment.
  • the hard capsules require different machinery for separation, filling, and reassembly thereof.
  • the hard capsules available worldwide, are manufactured by the aforementioned manufacturing process in various sizes to accommodate various dosage volumes and a variety of dosage formats.
  • the major drawback of the hard capsules is their inability to be sealed properly.
  • the hard capsules include an upper body and a lower body which are joined together by various techniques.
  • Typical hard capsules include a specifically engineered air gap and structures between the upper body and the lower body. The structures are adapted to assist in the venting of pressure created within an enclosed chamber. The pressure is created as the upper body is telescoped over the lower body and an available volume is compressed downwards, as part of the enclosure and locking process. Without these structures, the highspeed manufactured enclosure of commercially available capsules may become inefficient and unreliable over a period of time.
  • the hard capsules may contain liquid ingredients which may tend to leak out of gap(s) that are present in the venting structures between the upper body and the lower body.
  • Ingredients may also include sensitive ingredients, for example, probiotics, which are highly susceptible to moisture ingress through these structures in un-sealed capsules. Alternatively, a few sensitive ingredients may require a high moisture environment and a conventional enclosure may result in the dehydration of ingredients resulting in loss of efficacy thereof.
  • a layer of a sealant is applied on an exterior of the capsule body, specifically in the overlapping area of the upper body and the lower body.
  • the capsule may be fully sealed from the outside with a sealant layer.
  • the sealant layer may delay release of the ingredients, and may only find use in instances where such delay is desired.
  • the abovementioned sealing of an external surface of the enclosed capsule is advantageous as it allows the manufacturers to apply large volumes of sealant to the upper portion and the lower portion which may be subsequently sealed with high levels of airflow and temperature. There is a limited requirement for precise engineering and dosing of the capsule in such a case. This method may however expose the seal to external conditions and forces, due to which the capsule may experience high levels of production failure. Further, production rates are low as it takes time for the sealant to dry and may not work with all applications such as 3-part capsules. [0010] It is therefore advantageous to apply the method of internal application of the sealant between the upper body and the lower body prior to enclosure.
  • the sealant may be applied on an inner side of the upper body or an exterior side of the lower body.
  • the upper body and the lower body may then be enclosed. In doing so, both the upper body and the lower body are exposed to the sealant, thereby forming a seal between them.
  • US4403461 describes the challenges of mechanical scraping of the sealant from the inside of a capsule: “the adhesive is deposited inside the cap within a well-defined zone relatively distant from the edge of this cap, so that during fitting together, this adhesive tends to be pushed back inside the capsule and cannot, in any case, ooze out. ”
  • the referenced patent application further deals with the surplus pressure created from the compression of the internal volume between upper and lower bodies as the upper body is telescoped over the lower body during enclosure.
  • US4403461 attempts to seal a capsule under a vacuum in order to limit the outward venting effect. However, in the absence of a complete vacuum, the venting will still occur. Further, setting the sealant permanently requires time, thereby leading to a delay in withdrawing the vacuum.
  • the method suggested by the referenced patent application is slow, and includes highly technical manufacturing techniques, alongside producing a capsule that has a low internal pressure resulting in a likely failure of the capsule post-production.
  • US20110088355 describes pressure build-up due to recapping of the capsule, and the resultant venting.
  • the referenced patent application focuses on a pressure venting component of a recapping station aimed at serving to relieve pressure created by recapping.
  • US20100212261 also discloses pressure build-up created by the recapping of the capsule.
  • the referenced patent application mentions that “if the gas inside the capsule is under pressure, this may cause defects to occur in the applied band during or after the application of the banding liquid, as a result of gas escaping from the inside of the capsules at the junction with the cap. This induced gas flow leads to the formation of channels from the inside of the capsule to the outside and is observed for example through the formation of bubbles in the applied band at the junction of the banded capsule. ”
  • the patent application mainly aims at providing gases of differing temperatures aimed at mitigating the pressure build-up created through the recapping.
  • the above-mentioned conventional methods for sealing the capsules may make the capsule prone to mechanical disassembly and tampering, thereby leaving the ingredients available for overuse, substance abuse, etc., and may further carry risks of non-compliance with clinical trials. Regulatory exceptions, non-compliance notices, harm to industry reputation, and severe legal actions may be potential consequences of the same.
  • the capsules are required to be efficiently sealed with high integrity for delivering dosages. Further, the capsules are required to be leak-free, oxidization free, and strong for standing strong against the rigors of manufacturing, transportation, and for use and treatment by consumers.
  • the method includes positioning the first portion of the capsule to engage the surface of the first portion with a dosing head of a sealant dispenser.
  • a predetermined amount of a sealant is circumferentially applied onto the surface by the dosing head.
  • the sealant is adapted to be drawn into a space between the surface of the first portion and the surface of the dosing head.
  • the dosing head is adapted to dwell in an area of the sealant dosed onto the first portion for a predetermined dwell time ranging between 2 seconds to 5 seconds.
  • the predetermined amount of the sealant is in the range of 0.19 pl to 0.81 pl per millimetre diameter of the first portion.
  • the quantity of a sealant dosed is more than the predetermined amount, more than a desired amount of the sealant will be left as an excessive residue moisture on the first portion. Further, an inadequate amount of the sealant may not be able to make a bond at all or may make a weak bond.
  • the sealant is applied onto the surface with a predetermined dosing height ranging from 2 mm to 5 mm, and a predetermined dosing coverage ranging from 0.012 pl per mm 2 to 0.130 pl per mm 2 .
  • the predetermined dosing height and the predetermined dosing coverage of the sealant between the first portion and the second portion that are in contact with one another, are crucial factors, which help in managing a linear extent of the seal formed.
  • the sealant includes a solvent prepared by mixing water in a range of 5% to 30% by volume, with ethanol in a range of 70% to 95% by volume.
  • the first portion undergoes conditioning.
  • the method includes closing the capsule after the conditioning of the first portion, by positioning the second portion telescopically onto the first portion.
  • a surface of the second portion is concentrically positioned onto the surface of the first portion conditioned with the sealant.
  • the surface of the second portion fuses with the surface of the first portion due to the conditioning and absorption of the sealant into the second portion.
  • the term “conditioning” of the first portion refers to a partial softening of the surface of the first portion due to an introduction of moisture through the sealant. The moisture renders the first portion pliable and adhesive due to application of the sealant thereon.
  • the surface of the first portion includes either an internal surface of the first portion, or an external surface of the first portion.
  • the surface of the second portion includes either an internal surface of the second portion, or an external surface of the second portion.
  • a geometrical profile of the dosing head of the sealant dispenser depends on a shape of the first portion, and a desired location of the sealant to be applied to the surface of the first portion.
  • the method disclosed herein helps in preventing the forced leaking of the sealant during the closing of the capsule.
  • the method further helps in preventing mechanical scraping and disruption to the sealant layer while the dosing head is being lifted from the first portion after the application of the sealant on the surface of the first portion.
  • conditioning of the first portion by the method disclosed herein ensures forming of a fused bond which protects the ingredients of the capsule from leakage when the capsule is closed after conditioning of the first portion.
  • Figure 1 illustrates a block diagram depicting a method for conditioning a surface of a first portion of a capsule, according to an embodiment of the present disclosure
  • Figure 2a illustrates a schematic diagram depicting conditioning of an internal surface of the first portion of the capsule having a single compartment, according to an embodiment of the present disclosure
  • Figure 2b illustrates a schematic diagram depicting a conditioned internal surface of the first portion of the capsule having the single compartment, according to an embodiment of the present disclosure
  • Figure 3a illustrates a schematic diagram depicting conditioning of an external surface of the first portion of the capsule having a single compartment, according to an embodiment of the present disclosure
  • Figure 3b illustrates a schematic diagram depicting a conditioned external surface of the first portion of the capsule having the single compartment, according to an embodiment of the present disclosure
  • Figure 4a illustrates the process of dosing the sealant onto an inner surface of the first portion, such that the first portion is a cap of the capsule, according to an embodiment of the present disclosure
  • Figure 4b illustrates a conditioned inner surface of the first portion, such that the first portion is the cap of the capsule, according to an embodiment of the present disclosure
  • Figure 5a illustrates a schematic diagram depicting the process of dosing the sealant onto an external surface of the first portion and the second portion of the capsule having two compartments, according to an embodiment of the present disclosure
  • Figure 5b illustrates a schematic diagram depicting a conditioned external surface of the compartment of the capsule having the two compartments, such that the first portion is the body of the capsule, according to an embodiment of the present disclosure
  • Figure 5c illustrates a schematic diagram depicting the sealant between an internal surface of the compartment and an external surface of a membrane of the capsule having the two compartments, according to an embodiment of the present disclosure.
  • Figure 5d illustrates a schematic diagram depicting a combination of a conditioned external surface of the capsule body and a conditioned external surface of the membrane of the capsule having the two compartments, according to an embodiment of the present disclosure.
  • any terms used herein such as, “includes,” “comprises,” “has,” “consists,” and similar grammatical variants do not specify an exact limitation or restriction, and certainly do not exclude the possible addition of one or more features or elements, unless otherwise stated. Further, such terms must not be taken to exclude the possible removal of one or more of the listed features and elements, unless otherwise stated, for example, by using the limiting language including, but not limited to, “must comprise” or “needs to include.”
  • the present disclosure relates to a method of application of a sealant on a first portion of a capsule, before a second portion of the capsule is telescopically engaged with the first portion, such that the second portion overlaps a portion of the first portion which has been conditioned by the application of the sealant.
  • the present disclosure relates to a pre-closure application of sealant onto the first portion of the capsule.
  • pre-closure refers to a time before the first portion is closed by the second portion.
  • the pre-closure application of the sealant to seal the capsule holds numerous challenges. For instance, during the pre-closure application of the sealant, only a predetermined amount of the sealant must be dosed onto the first portion. Once closed, the sealant dosed on the first portion will be covered from all sides, thereby losing the ability to be externally heated or dried. Consequentially, if an unspecific amount of the sealant is dosed onto the first portion, either the sealant would be too less in the amount, or excessive in the amount. In a scenario where the amount of sealant is too less in the amount, the sealant may not be able to form a strong and continuous bond between the first portion and the second portion.
  • the sealant may leave behind a high level of residual moisture, given that this moisture has nowhere to go but interact with the capsule portions. Due to the hydroscopic nature of capsule materials, the excess moisture renders the capsule material soft and pliable, thereby affecting the integrity of the capsule, and ultimately resulting in capsule failure.
  • the amount of the sealant being applied to the first portion is controlled, thereby preventing application of the sealant in the excessive amount, as there may be a possibility that the sealant in the excessive amount may also leak during the closing of the capsule. Only an amount of the sealant sufficient for conditioning the first portion is dosed by a dosing head of a sealant dispenser.
  • the dosing head lifted upwards, thereby preventing mechanical scraping of the sealant layer deposited on the first portion, by the dosing head whilst it is being lifted. Further, conditioning of the first portion and closing the first portion with the second portion fuses both the first portion and the second portion with a bond efficient enough to protect the ingredients of the capsule from leakage when the capsule is closed post-conditioning of the first portion.
  • the first portion may be any portion of the capsule on which the sealant may be dosed.
  • the first portion may be a body (lower portion) of the capsule, the sealant may be dosed onto a surface of the body, as depicted in Figures 2a- 3b, and Figures 5a-5d.
  • the second portion 416 (as shown in Figures 5a-5d) will be a cap (upper portion) of the capsule, which is telescoped onto the first portion 202 after conditioning of the first portion 202 with the sealant.
  • the first portion 202 may be the cap, as the sealant may be dosed onto a surface 204 of the cap, as shown in Figures 4a and 4b.
  • the second portion will be the body of the capsule, on which the conditioned first portion 204-A (cap) may be telescoped after conditioning of the first portion 202 with the sealant.
  • Figure 1 illustrates a block diagram depicting a method 100 for sealing a capsule.
  • the capsule may include a first portion 202 and a second portion 416 (the second portion has been depicted in Figure 5d with referral numeral 416 and the same is applicable for description of all the Figures), as depicted in Figures 2a-3b.
  • Figure 2a illustrates a schematic diagram 200 depicting conditioning of an internal surface 204 of the first portion 202 of the capsule having a double compartment after the insertion of membrane 408, and
  • Figure 2b illustrates a schematic diagram 300 depicting a conditioned internal surface 204-A of the first portion 202 of the capsule having the double compartment.
  • Figure 3a illustrates a schematic diagram 400 depicting conditioning of an external surface 212 of the first portion 202 of the capsule having a single compartment
  • Figure 3b illustrates a schematic diagram 500 depicting a conditioned external surface 212- A of the first portion 202 of the capsule having the single compartment.
  • the first portion 202 and the second portion may be made up of, but is not limited to, animal products, fish products, a vegetable gelatine material, cellulose such as HPMC (hydroxypropyl methylcellulose or Hypromellose), and polymers.
  • the material used in manufacturing the first portion 202 and the second portion 416 may initially be in a crystalline form, as the capsules are manufactured through a dipping or forming process that is reconstituted.
  • the method 100 includes two major steps, including conditioning the surface 204, 212 of the first portion 202 and closing the capsule.
  • the method 100 includes positioning the first portion 202 of the capsule to engage the surface 204, 212 of the first portion 202 with a dosing head 302, 502 of a sealant dispenser.
  • the first portion 202 may include an ingredient therein.
  • the ingredient may include, but is not limited to, a pharmaceutical material, a nutritional supplement, and a nutraceutical material.
  • the first portion 202 may be positioned and held in place by a shuttle to be engaged with a surface of the dosing head 302.
  • the surface 204, 212 of the first portion 202 may include either the internal surface 204 of the first portion 202, or the external surface 212 of the first portion 202.
  • a geometrical profile of the dosing head 302 of the sealant dispenser may depend on a shape of the first portion 202, and a desired position of the sealant on the surface 204, 212 of the first portion 202.
  • the dosing head 302 may have a closed cylindrical geometry, such that a closed cylindrical tip of the dosing head 302 may be inserted into the first portion 202 having a hollow cylindrical portion, through an upper end of the hollow cylindrical portion. A lower end of the hollow cylindrical portion may be closed by a hemispherical portion formed below the hollow cylindrical portion.
  • the first portion 202 may include a body of the capsule, on which the sealant may be dosed, as depicted in Figures 2a-3b, and Figures 5a-5d (explained later).
  • the second portion 416 will be a cap of the capsule, which is telescoped onto the first portion 202 after conditioning of the first portion 202 with the sealant.
  • the first portion 202 may be the cap of the capsule, on which the sealant may be dosed, as depicted in Figures 4a and 4b.
  • Figure 4a illustrates dosing process of the sealant onto an inner surface of the first portion 202, such that the first portion 202 is the cap of the capsule
  • Figure 4b illustrates a conditioned inner surface 204-A of the first portion 202, such that the first portion 202 is the cap of the capsule.
  • the second portion will be the body of the capsule, on which the conditioned first portion 202 (cap) may be telescoped after conditioning of the first portion 202 with the sealant.
  • the dosing head 502 may have the hollow cylindrical geometry, the upper end of the hollow cylindrical portion of the first portion may be inserted into a hollow cylindrical tip of the dosing head 502, such that the external surface 212 of the first portion 202 is engaged with an internal surface of the hollow cylindrical geometry of the dosing head 502.
  • the method 100 includes circumferentially applying a predetermined amount of the sealant onto the surface 204, 212 by the dosing head 302, 502.
  • the sealant comprises a solvent prepared by mixing water in a range of 5% to 30% by volume, with ethanol in a range of 70% to 95% by volume.
  • the water content dictates the metrics of the sealant, as the water delivers the key bonding effect and ethanol is seen as a carrier agent.
  • the capsule configuration may have a higher chance of deformation and breakage. Further, the time taken for stabilization of the excessive moisture may be longer and the capsule may have a higher degree of potential for failure. Water further provides greater volume to assist in micro-dosing of the sealant and is easily evaporated postapplication.
  • the amount of sealant being applied onto the surface 204, 212 of the first portion 202 should neither be more than nor less than the predetermined amount, as excessive sealant may not be able to be removed from the first portion 202. Further, an inadequate amount of sealant may not be able to make a bond at all or may make a weak bond.
  • the predetermined amount of sealant may depend on whether conditioning is being done with the use of a vacuum or not. In one embodiment, the predetermined amount of the sealant may be in the range of 0.19 pl to 0.81 pl per millimeter diameter of the first portion 202.
  • the sealant is adapted to be drawn into a space between the surface 204, 212 of the first portion 202 and the surface of the dosing head 302, 502 through a capillary action. Due to the capillary action, the sealant may be applied onto the surface 204, 212 by being drawn into the space, with a predetermined dosing height.
  • the predetermined dosing length may range from 2 mm to 5 mm. The predetermined dosing length may be taken along a longitudinal axis A- A’ (as shown in Figure 2a) of the first portion 202.
  • the dosing head 302 is adapted to dwell in an area of the sealant dosed onto the first portion 202 for a predetermined dwell time ranging between 2 seconds to 5 seconds.
  • the sealant is adapted to be absorbed into the first portion 202 for a predetermined absorption time ranging between 2 seconds and 5 seconds.
  • the “predetermined absorption time” refers to the amount of time the sealant takes to be optimally absorbed into the first portion 202. If the sealant is left for a shorter predetermined absorption time on the first portion 202, the conditioning of the first portion 202 will not happen properly. Such underconditioning of the capsule shall lead to inadequate bonding between the first portion 202 and the second portion 416, 408, 402 due to inadequate surface preparation.
  • the dosing head 302, 502 is adapted to dwell in an area of the sealant dosed onto the first portion 202 for a predetermined dwell time.
  • predetermined dwell time refers to a time for which the dosing head 302, 502 remains engaged with the first portion 202 while conditioning of the first portion 202 is in progress.
  • the dosing head 302, 502 is lifted only after the completion of the predetermined dwell time giving the sealant the opportunity to be mostly absorbed into the surface 204, 212 of the first portion 202 thereby avoiding the mechanical scraping to a sealant layer 304, 504 dosed onto the first portion 202, while lifting the dosing head 302, 502 up.
  • the dosing head 302, 502 limits dripping of the sealant downwards due to gravity. This ensures that the sealant remains in an intended conditioned surface 304-A, 306-A on the surface 204, 212 of the first portion 202. Further, retaining the dosing head 302, 502 in the dosing position until the conditioning process completes, helps in avoiding either mechanical or vacuum-induced scraping of the sealant while pulling the dosing head 302, 502 upwards.
  • the excessive residue may be scraped, shoveled, or vented as a result of the telescoping of the second portion 416 over or inside the first portion 202.
  • Adequate capsule conditioning ensures that limited excessive residual liquid remains that could be displaced equally, so that sufficient conditioning takes place to ensure a reliable seal. Further scraping can not only displace the sealant thereby compromising the seal, but it can also result in high quantities of sealant being located and concentrated areas on the first portion 202, commonly referred to as “snowplowing”.
  • snowplowing refers to the accumulation of the excessive moisture residue in a localized area, giving rise to over-hydration of the localized area, resulting in collapse of the capsule.
  • the conditioning of the first portion 202 through the partial absorption of the sealant into the first portion 202 ensures that the process of adhesion takes place prior to the enclosure of the second portion 416. This also reduces excessive residue liquid, thereby avoiding displacement of the sealant and the creation of channels due to the venting of pressure created due to telescoping engagement of the second portion 416.
  • over conditioning due to excessively long dwell times results in over absorption of sealant on the first portion 202, migration of the moisture through the first portion, 202 and dispersing the moisture away from the intended sealing area. All of which give rise to failure in the capsule integrity due to overhydration or failure of the seal due to inadequate transferal of surface moisture to the second portion 416. In some cases, over conditioning may result in the premature drying of the conditioned surface 304-A, 306-A compromising its ability to bond to the second portion 416.
  • the first portion 202 undergoes conditioning, which is known as conditioning of the first portion 202.
  • conditioning which is known as conditioning of the first portion 202.
  • the time for which the first portion 202 is to be conditioned is one of the key aspects to be considered. If not maintained, an alteration in the character of the capsule may be noticeable throughout the conditioning stage. The longer the sealant is left on the first portion 202, the tackier and greater the propensity to bond. If the sealant is left for too long, the capsule may become overly flexible and begin to lose integrity. Loss of integrity may result in damage to the capsule due to the forces generated during recapping of the second portion 416or insertion of a membrane into the first portion 202. Further, if the sealant is left for too long, evaporation of the sealant and the capsule material may take place, resulting in dehydration and reversal of the conditioning process.
  • an over-conditioned capsule may encourage snow ploughing of the capsule material.
  • the sealant may spread and result in failure to form a continuous seal between the first portion 202 and the second portion 416. The spreading of the sealant may further stress the capsule, thereby increasing the likelihood of the capsule becoming prone to leakage.
  • the method 100 includes closing the capsule after the conditioning of the first portion 202.
  • the second portion 416 is positioned telescopically onto the first portion 202.
  • the second portion 416 may have a similar geometrical profile as that of the first portion 202.
  • a surface of the second portion 416 is concentrically positioned onto the surface 204, 212 of the first portion 202 conditioned with the sealant.
  • the surface of the second portion 416 may include either an internal surface (not shown) of the second portion 416, or the external surface (not shown) of the second portion 416.
  • the sealant will be applied to an internal surface 204 of the first portion 202.
  • the second portion 416 will be inserted into the first portion 202 such that the external surface of the second portion 416 faces the internal surface 204 of the first portion 202.
  • the sealant will be applied at the external surface 212 of the first portion 202.
  • the second portion 416 will be capped onto the first portion 202 such that the internal surface of the second portion 416 overlaps the external surface 212 of the first portion 202.
  • application of the sealant hydrates the first portion 202 sufficiently, such that the first portion 202 undergoes weakening of bonds, to change a state of the first portion 202 from solid and dry to tacky, adhesive, and equally susceptible to deformation, thereby conditioning the first portion 202.
  • the second portion 416 is brought in contact with the first portion 202 thereafter, which creates an area of fusion between the first portion 202 and the second portion 416, thereby sealing the first portion 202 and the second portion 416 together.
  • the amount of sealant being dispensed from the dosing head 302, 502 is required to be maintained, as the residual moisture, if present in high amounts, may compromise integrity between the first portion 202 and the second portion 416.
  • the residual moisture from the sealant migrates through walls of the capsule, drying and hardening until the sealant-rich homologated zone returns to a dry and fused state.
  • the process of applying the sealant in effect delivers a reservoir of moisture that is transferred to the surface 204, 212 of the first portion 202, thereby treating the surface.
  • the conditioned surface 304-A, 306-A becomes the reservoir of moisture.
  • the reservoir transfers a portion of the moisture into the non-conditioned surface of the second portion 416, thereby hydrating the surface of the second portion 416. This further ensures that no single portion receives a higher quantity of the sealant, and this results in a more predictable and even level of absorption as well as a capsule configuration that has not overhydrated and is robust.
  • the second portion 416 must be fused with the first portion 202 rapidly after conditioning the first portion 202 to avoid migration or dissipation of the sealant away from the sealed area, and to avoid formation of droplets of the sealant.
  • the sealant is discharged from the dosing head 302, 502 until the sealant covers a predetermined dosing height across the entire circumferential surface of the first portion 202 .
  • the bonding of the first portion 202 and the second portion 416 happens efficiently as a result of optimal hydration.
  • the capsule may lose integrity due to a weak bond.
  • the dosing area remains isolated from the external environment and has a limited exposed area for evaporation and drying of the sealant.
  • the sealant is applied onto the surface 204, 212 of the first portion 202 with a predetermined dosing coverage ranging from 0.012 pL per mm 2 to 0.13 pL per mm 2 .
  • the predetermined dosing height of the seal between the first portion 202 and the second portion 416 that are in contact with one another is a crucial factor, which helps in managing an extent of area on which the seal may be formed.
  • the area extent of the seal must be sufficient to provide strength to the seal, such that the first portion 202 and the second portion 416 not only stay in place but are also able to deal with any potential pressure generated and retained in enclosed volume inside the capsule.
  • the pressure may increase in cases where the ingredients are exposed to heat, and therefore the length of the seal must be greater to provide enough strength to the seal.
  • the pressure may be decreased due to high altitudes in a scenario where the capsules may be transported via air.
  • the capsule may have more than one ingredient chamber, as depicted in Figures 5a-5d.
  • Figure 5a illustrates a schematic diagram 600 depicting the process of dosing on an external surface of the compartment 402 of the capsule having the two compartments 402, 408, such that the compartment 402 is the first portion 202 of the capsule.
  • Figure 5b illustrates a schematic diagram depicting the sealant a conditioned external surface of the compartment 402 of the capsule having the two compartments 402, 408, such that the compartment 402 is the first portion 202 of the capsule .
  • Figure 5c illustrates a schematic diagram depicting the sealant between an internal surface of the compartment 402 and an external surface of a membrane 414 of the capsule having the two compartments 402, 408.
  • Figure 5d illustrates a schematic diagram depicting a combination of conditioned external surface of the compartment 402 and a conditioned external surface of the membrane 414 of the capsule having the two compartments 402, 408.
  • the capsule may include a membrane 414 that is telescopically fixed into the compartment 402 by interference fit, and bonded with the compartment 402 with help of the sealant, by using the method 100.
  • the membrane may be adapted to divide the capsule in more than one compartments 402, 408.
  • the membrane 414 may be considered as the first portion 202 (as explained in the paragraphs [0050] and [0060]).
  • the sealant may be dosed onto an external surface of the membrane 414, and the membrane 414 may then be telescopically fit into the compartment 402 after conditioning of the external surface of the membrane 414.
  • the compartment 402 may be considered as the first portion 202 (as explained in the paragraphs [0050] and [0060]).
  • the sealant may be dosed onto an internal surface of the compartment 402.
  • the inner surface of the compartment 402 gets conditioned with the help of the sealant. Consequently, the membrane 414 may be telescopically fit into the compartment 402 after conditioning of the inner surface of the compartment 402.
  • the second portion 416 may then be engaged with the compartment 402 with the method 100 as already explained above with reference to Figures l-3b.
  • the membrane 414 helps in dividing the capsule into two compartments 402, 408, for containing two different ingredients for being consumed together.
  • the method 100 may be applicable to capsules having more than two compartments.
  • the method 100 may be applicable to capsules having variable configurations. [0084] All of the mechanical and material principles and benefits of the method 100 disclosed herein help in securing a reliable seal between compartments 402 and 408 thereby ensuring that all ingredients delivered in compartments 402 and 408 remain hermetically confined.
  • the method 100 ensures a continuous and efficient seal between the compartment 402 and the second portion 416, which may be capable of restricting oxygen ingress into the capsule, thereby preventing oxidation of the ingredients therein.
  • the same helps in ensuring an efficient delivery of the dosage form as well as dosage amount, by ensuring that no part of the ingredients is accidentally oxidized.
  • the seal further limits the degradation of moisture-sensitive ingredients such as probiotics, which in turn also have a major impact on the efficacy of such sensitive ingredients.
  • the method 100 helps in controlling the amount of sealant being applied to the compartment 402, thereby ensuring an optimal conditioning level of the compartment 402. Further, the method 100 also helps in controlling the predetermined absorption time of the sealant into the compartment 402, before closing the capsule with the second portion 416. Controlling the amount of the sealant being applied and the predetermined absorption time and the dwell time for which the sealant is left on the surface 404, 412, helps in achieving a seal that is robust, and long-lasting.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un procédé de conditionnement d'une surface d'une première partie d'une capsule. Le procédé comprend le positionnement de la première partie de la capsule pour venir en prise avec la surface de la première partie avec une tête de dosage d'un distributeur de produit d'étanchéité. Une quantité prédéterminée de produit d'étanchéité est appliquée de manière circonférentielle sur la surface par la tête de dosage. Le produit d'étanchéité est conçu pour être aspiré dans un espace entre la surface de la première partie et une surface de la tête de dosage par action capillaire. Le produit d'étanchéité est conçu pour être absorbé dans la première partie pendant un temps de conditionnement prédéterminé compris entre 2 seconde et 5 secondes.
PCT/IN2024/050511 2023-06-26 2024-05-10 Procédé de conditionnement d'une surface d'une première partie d'une capsule Pending WO2025004062A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202321042759 2023-06-26
IN202321042759 2023-06-26

Publications (1)

Publication Number Publication Date
WO2025004062A1 true WO2025004062A1 (fr) 2025-01-02

Family

ID=93937842

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2024/050511 Pending WO2025004062A1 (fr) 2023-06-26 2024-05-10 Procédé de conditionnement d'une surface d'une première partie d'une capsule

Country Status (1)

Country Link
WO (1) WO2025004062A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20070007315A (ko) * 2004-02-27 2007-01-15 아이.엠.에이. 인듀스트리아 마친 오토메티크 에스.피.에이. 시일링된 캡슐을 제조하기 위한 방법 및 이것에 관련된캡슐 충전 장치
WO2021024930A1 (fr) * 2019-08-02 2021-02-11 クオリカプス株式会社 Formulation de capsule dure scellée avec un bande de scellement comprenant une étiquette

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20070007315A (ko) * 2004-02-27 2007-01-15 아이.엠.에이. 인듀스트리아 마친 오토메티크 에스.피.에이. 시일링된 캡슐을 제조하기 위한 방법 및 이것에 관련된캡슐 충전 장치
WO2021024930A1 (fr) * 2019-08-02 2021-02-11 クオリカプス株式会社 Formulation de capsule dure scellée avec un bande de scellement comprenant une étiquette

Similar Documents

Publication Publication Date Title
US4250997A (en) Locking capsule filled with viscous material
US4196564A (en) Method of manufacturing a joined capsule filled with viscous material
CA1252441A (fr) Methode de scellement de capsules
US4749600A (en) Liquid absorbing and immobilizing packet
CA1283391C (fr) Methode de scellement de capsules de gelatine ferme
CA2617967C (fr) Contenant
AU2014246703B2 (en) Capsule with internal diaphragm
WO2025004062A1 (fr) Procédé de conditionnement d'une surface d'une première partie d'une capsule
KR100478350B1 (ko) 캡슐의밴드형밀봉부형성방법
JP5622185B2 (ja) 粉末高含有軟カプセル及びその製造方法
EP4225276B1 (fr) Fluide d'étanchéité pour sceller des capsules
RU2386433C2 (ru) Контейнер
GB1596008A (en) Sealed capsule
EP2800720B1 (fr) Capsule pour encapsuler un comprimé
CA2508963C (fr) Methode pour former une bande de scellement sur une capsule
TWI612976B (zh) 膠囊之封存組合物及其封存方法
US20050257498A1 (en) Tube filling process for liquid filled cotton swabs

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24831246

Country of ref document: EP

Kind code of ref document: A1

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112025029069

Country of ref document: BR