Capsules with reduced powder leakage

Abstract

The present invention relates to a capsule shell having two parts, a cap and a body, which are telescopically engaged with each other, the capsule shell being used to store a solid substance in powder or granular form and exhibiting a minimized powder leakage rate when the capsule shell is filled with the solid substance in powder form and closed.

Description

Technical Field

[0001] The present invention relates to a capsule shell having two parts, namely a cap and a body, which are telescopically engaged with each other, the capsule shell being used to store solid matter in powder or granular form and exhibiting a minimized powder leakage rate when the capsule shell is filled with the solid matter in powder form and closed. Background Art

[0002] A standard container for solid-form medicines or other substances may be a capsule shell having two parts: a cap portion, also referred to as a cap, and a body portion, also referred to as a body. The cap and body are telescopically engaged with each other to close the capsule shell.

[0003] WO 97 / 17049 A1 in Figure 1 A telescopic capsule shell of this type is disclosed in [1], which has two telescopically joined parts, namely a cap and a body. The body of the capsule has a vent. In addition, the body has a ring-closure protrusion extending circumferentially around the body. Adjacent to the section with the ring-closure protrusion, the body extends toward its closed end in a hollow cylindrical shape. The vent extends from the edge of the open end of the body throughout the entire length of the section of the body with the ring-closure protrusion and into the section with the hollow cylindrical shape. The cap generally has a hollow cylindrical shape, as desired for a dome-shaped closed end. In the section of the cap with the hollow cylindrical shape, the cap has separate elliptical protrusions around its circumference. These protrusions interact with the ring-closure protrusions of the body in the pre-sealed position. The section carrying these elliptical protrusions itself does not exhibit further notches, so the area between the protrusions has the same diameter as the rest of the hollow cylindrical section of the cap.

[0004] A disadvantage of the disclosed capsule shell is that it has a certain leakage rate when it is filled with a solid substance in powder form.

[0005] There is a need for a telescoping capsule casing having these two telescopically joined parts, the cap and the body, which exhibits a reduced leakage rate.

[0006] The present invention relates to a specific design of the cap and body for reducing the leakage rate of powdered material contained within a capsule shell. Summary of the Invention

[0007] The subject of the present invention is a telescopic capsule shell CAPSSHELL having two separate parts, namely a cap and a body, wherein the cap and the body telescopically engage each other to close the CAPSSHELL;

[0008] The cap has a closed end CEC (20) and an open end;

[0009] The body has a closed end CEB (10) and an open end;

[0010] The cap contains four consecutive segments SC0, SC1, SC2, and SC3;

[0011] SC0 contains CEC (20);

[0012] SC1 comprises a closed ring CRC of the cap in the form of a protrusion extending over the entire circumference of the cap;

[0013] SC2 contains the protrusion region RPC of the cap;

[0014] SC3 contains the edge RIC of the open end of the cap;

[0015] The body consists of four consecutive segments SB0, SB1, SB2, and SB3;

[0016] SB0 contains CEB (10);

[0017] SB1 contains the hollow cylindrical segment CSB of the main body;

[0018] SB2 comprises a closed ring CRB of the body in the form of a protrusion extending over the entire circumference of the body;

[0019] SB3 includes the edge RIB of the open end of the body;

[0020] There are at least two protrusions PRPC in the RPC, the protrusions being separated from each other by portions of the RPC in the circumferential direction of the cap;

[0021] The closed position is where the cap is fully engaged with the body such that the CASPSHELL is closed.

[0022] In the closed position, the CRC engages the CRB;

[0023] Any protrusion of the CAPSSHELL extending inwardly into the cavity of the cap or body, respectively;

[0024] The extension of the CAPSSHELL when the cap is telescopically engaged with the body in the direction of its length is designated as the x-direction;

[0025] It is characterized by

[0026] There are at least two vents AV in the RIB in the form of projections, which are separated from each other and extend from the edge EB of the open end of the body to the CRB;

[0027] and

[0028] The RPC extends over the entire circumference of the cap.

[0029] abbreviation

[0030] The following abbreviations are used in this manual:

[0031] API active pharmaceutical ingredient

[0032] AV vent

[0033] CAPSSHELL capsule shell

[0034] Closed end of the CEB body

[0035] Closed end of the CEC cap

[0036] CMC Carboxymethyl Cellulose

[0037] Closed loop of the CRB body

[0038] Hollow cylindrical section of the CSB body

[0039] Closed loop of the CRC cap

[0040] DAV is between the lowest point of the outer surface of the recess formed by the AV and the outer surface of the diametrically opposed point of the wall of the RIB

[0041] DCRB The diameter between two diametrically opposed points on the outer surface of the CRB where the depth of the notch formed by the CRB is greatest

[0042] DCRC is the diameter between two diametrically opposed points on the inner surface of the CRC at the longitudinal point of maximum depth of the notch formed by the CRC.

[0043] DRPC is the diameter between two diametrically opposed points on the inner surface of the RPC, excluding any area formed by the PRPC, at the point of maximum depth of the recess formed by the RPC, i.e., at the lowest point of the inner surface of the RPC in the x-direction.

[0044] D-CEC-CRC The inner diameter of CEC and CRC at the transition between CEC and CRC

[0045] D-CRC-RPC Inner diameter of CRC and RPC at the transition between CRC and RPC

[0046] D-RPC-RIC At the transition between RPC and RIC, the inner diameters of RPC and RIC

[0047] DIPSOL FILMPOLYM solution in water

[0048] Dissolution of DISSOL FILMPOLYM in water

[0049] DPRPC is the diameter between the lowest point of the inner surface of the recess formed by the PRPC and the diametrically opposite point on the inner surface of the cap wall.

[0050] The edge of the open end of the EB body, i.e. the cutting edge of the RIB

[0051] The edge of the open end of the EC cap, i.e. the cutting edge of the RIC

[0052] FILLFORMUL Formulations filled into CAPSSHELL

[0053] FILMCOMP Capsule film composition

[0054] FILMPOLYM film-forming polymers

[0055] FURTHERSUBST Additional substances optionally included in FILMCOMP

[0056] HPMC Hydroxypropyl Methylcellulose

[0057] ICRC The interference between the lowest point of the inner surface of the recess formed by the CRC and the outer surface of the body, wherein the body has its largest diameter, preferably MDB

[0058] IDPRPC The interference between the lowest point of the inner surface of the recess formed by the PRPC and the outer surface of the body, where the body has its largest diameter, preferably MDB

[0059] Ingredients in INGR FILLFORMUL

[0060] Maximum outer diameter of the MDB body

[0061] Maximum inner diameter of the MDC cap

[0062] PINTEMP mold pin temperature

[0063] PLF pre-locking force

[0064] PROCFORMCAPS Process for the Preparation of CASPSHELL

[0065] PRPC protrusions in RPC

[0066] The edge of the open end of the RIB body

[0067] RIBC The closed end of the RIB segment towards the body

[0068] RIBO The segment of the RIB faces the open end of the body

[0069] The edge of the open end of the RIC cap

[0070] The protrusion area of the RPC cap

[0071] SB0, SB1, SB2, SB3 body segments

[0072] SC0, SC1, SC2, SC3 cap segments

[0073] SFF snap fit DETAILED DESCRIPTION

[0074] By providing the at least two AVs in the RIB extending from the EB into the CRB but not throughout the entire length of the CRB into the CSB, and by providing the RPC extending throughout the entire circumference of the cap, and by providing the PRPC in the RPC, the leakage rate is reduced.

[0075] Any AV in the RIB extends from the EB to the CRB, but does not extend into the CSB along the entire length of the CRB. Any AV terminates at or in the CRB. The CSB does not contain an AV or any portion of an AV. If an AV protrudes into the CSB, this will result in an opening in a closed position, which may cause powder leakage.

[0076] In the sense of the present invention, telescopic engagement means that the inner wall of the cap is at least partially in contact with the outer wall of the body. This also means that the cap and the body show at least partial fit of their forms where they overlap in the closed position. The telescopic engagement of the cap and the body can be achieved by sliding the cap over the body, in other words, by inserting the body into the cap. The body is slid into the cavity of the cap with the open end first. As a result, the cap and the body are at least partially properly connected or engaged. Therefore, the telescopic engagement device at least partially forms the proper engagement of the cap and the body.

[0077] In the closed position, the CAPSSHELL may have a substantially hollow cylindrical shape.

[0078] In the closed position, the telescopic engagement of the cap with the body may extend across SC1 , SC2 and SC3 of the cap and across SB3, SB2 and SB1 of the body, or at least across a portion of SB1 .

[0079] The pre-closed position of the CAPSSHELL is a position in which the cap is only partially engaged with the body in a telescopic manner. The CAPSSHELL is not yet closed in the pre-closed position.

[0080] When the cap is telescopically engaged with the body, such as in the closed or pre-closed position, the extension of the capscell in the direction of its length can be designated as the x-direction, or longitudinal direction. Similarly, the length of the cap and the length of the body refer to their lengths in the x-direction. Therefore, the term "length" is used to refer to the length in the x-direction. The length of the cap extends in the x-direction from the edge EC of the cap's open end to the end CEC. The length of the body extends in the x-direction from EB to the end CEB.

[0081] Width in the sense of the present invention means the direction along the circumference of the cap or the body, respectively.

[0082] Any protrusion within the meaning of the present invention is any kind of recess or groove, regardless of its shape, which extends inwardly into the cavity of the cap or body, respectively. The inward direction may be perpendicular to the surface of the wall. When the protrusion is observed from the outside of the cap or body, respectively, the protrusion forms a recess or groove in the wall of the cap or body, respectively.

[0083] Depth in the sense of the present invention means the direction from the outer surface into the cavity of the cap or body. The direction of the depth may be perpendicular to the surface of the cap or body.

[0084] The maximum inner diameter MDC of the cap may be the maximum inner diameter of the RIC.

[0085] The maximum outer diameter MDB of the body may be the maximum outer diameter of the RIB.

[0086] In the sense of the present invention, any diameter of the cap refers to the inner diameter, ie the diameter of two diametrically opposed points of the inner surface of the cap, if not expressly stated otherwise.

[0087] In the sense of the present invention, any diameter of a body refers to the outer diameter, ie the diameter of two diametrically opposed points of the outer surface of the body, if not expressly stated otherwise.

[0088] During or after telescopic engagement of the body and the cap, interference occurs between the body and the cap.

[0089] Interference in the sense of the present invention means that when the CAPSSHELL is closed or pre-closed, i.e. when the cap and body are in the closed or pre-closed position, the diameters of two diametrically opposite points on the inner surface of the cap are smaller than the corresponding diameters of corresponding diametrically opposite points on the outer surface of the body.

[0090] Interference can also occur during the telescopic engagement of the cap with the body, meaning that the diameter between two diametrically opposed points on the inner surface of the cap is smaller than the MDB, which can be the maximum outer diameter of the RIB. This interference creates tension in the radial direction when the cap is telescopically engaged with the body, and thus requires the application of force during the sliding of the cap over the body.

[0091] At the point where interference occurs, the interference causes the cap and / or body to deform.

[0092] During telescopic engagement of the cap and body, ie during sliding of the cap across the body, forces are required to deform the walls of the cap and / or body at the points and / or along the path where interference occurs.

[0093] Interference in the closed or pre-closed position means that the engagement of the cap with the body is a press-fit engagement.

[0094] The open position of a CAPSSHELL is any position of its cap and body in which the cap and body are separated from each other and any telescopic engagement of the cap with the body has not yet begun. Telescopic engagement of the cap with the body begins when the cap approaches the body in the x-direction from the open position and an edge EC of the open end of the cap is aligned in the x-direction with an edge EB of the open end of the body.

[0095] In the pre-closed position, the telescopic engagement of the cap with the body may extend across a portion of SC1 , SC2 , and SC3 of the cap and across a portion of SB3 , SB2 , and SB1 of the body.

[0096] In one embodiment A of the CAPSSHELL, the PRPC engages the CSB in the pre-sealed position. In this position, the CRC is on the other side of the RIB relative to the CRB, i.e., on the open end of the RIB. The PRPC is positioned within the RPC at a distance in the x-direction from the position of the CRC's minimum diameter that is greater than the x-direction distance between the EB and the end of the CRB adjacent to the CSB.

[0097] In another embodiment B of the CAPSSHELL, the PRPC engages the CRB in the pre-sealed position. In this pre-sealed position, the CRC is on the opposite side of the RIB from the CRB, i.e., on the open end of the RIB. The PRPC is positioned within the RPC at a distance in the x-direction from the location of the CRC's minimum diameter, which is equal to the x-direction distance between the EB and the location of the CRB's minimum diameter.

[0098] During the telescopic engagement of the cap and the body, in particular when bringing the body and the cap from the pre-closed position to the open position, a pre-locking force PLF must be applied. The PLF is the force required to move the cap from the pre-closed position to the open position; preferably, it is the maximum force generated during the movement of the cap from the pre-closed position to the open position.

[0099] The snap-fit force SFF is the force required to move the cap from the closed position to the open position; preferably, it is the maximum force generated during the movement of the cap from the closed position to the open position.

[0100] The PLF is preferably smaller than the SFF. The PLF may be 0.1 to 0.2 N. The SFF may be 3 to 6 N.

[0101] PLF may be caused by interference that occurs during the telescopic engagement of the cap with the body

[0102] SFF may be caused by interference occurring during the telescopic engagement of the cap with the body

[0103] The main part of the cap may have a hollow cylindrical shape; this is essentially related to SC3, SC2 and SC1.

[0104] The RIC may have a length of 0 to 20%, preferably 5 to 15%, of the length of the cap. When the RIC has a length of 0% of the length of the cap, then the RIC is effectively an EC. When the RIC has a length greater than 0% of the length of the cap, then its surface may be flat and may be part of or contribute to the hollow cylindrical shape of the cap.

[0105] The RPC forms a recess in the cap wall that extends into the cavity formed by the cap. The recess extends over the entire circumference of the cap. The RPC may have a length of 30 to 40% of the length of the cap, preferably 33 to 40%. The shape of the longitudinal cut of the recess formed by the RPC in the x-direction may be a curved shape, preferably a concave curved shape, in particular a concave curved shape forming a partial ellipse, or the shape of a barrel with a flat bottom and a rounded bevel. The shape of the longitudinal cut of the recess formed by the RPC in the x-direction may, for example, have a U-shape or a V-shape, preferably a U-shape.

[0106] The RPC has a smaller inner diameter than the MDC. At the point of maximum depth of the RPC recess, i.e., the lowest point of the RPC's inner surface in the x-direction, excluding any areas formed by the RPC, the reduction in diameter between two diametrically opposed points on the RPC's inner surface can be 0.5% to 2% of that of the MDC. Thus, at the point of maximum depth of the RPC recess, i.e., the lowest point of the RPC's inner surface in the x-direction, excluding any areas formed by the RPC, the diameter DRPC between two diametrically opposed points on the RPC's inner surface can be 98% to 99.5% of that of the MDC. Preferably, the lowest point of the RPC's inner surface extends over the entire circumference of the RPC; thus, the lowest point is effectively a line, preferably a straight line forming a loop. This is preferably the case when the longitudinal cutout in the RPC in the x-direction can have a U- or V-shape, preferably a U-shape. The maximum depth of the RPC recess can be 10 to 40 micrometers.

[0107] During the telescopic engagement of the cap with the body, i.e. during the sliding of the cap over the body, no interference occurs between the RPC and the circumference of the body with the MDB, except in any area formed by the DRPC. This means that the DRPC is equal to or greater than the MDB. The depth of the gap formed between the RPC and the point of the body with the MDB is called the spacing and can be represented by (DRPC-MDB) / 2. The spacing can range from 0 to 50 microns, preferably from 0 to 20 microns, and the spacing can extend continuously for up to 80%, preferably up to 70% of the length of the RPC. The RPC can therefore be shaped, for example, in the form of a concave curved depression throughout its length, in which case the spacing only exists at the point of the largest depression of the concave curved RPC, or the RPC can be shaped to have three consecutive segments throughout its length: a first segment with an inclination that produces a depression; a second segment, an intermediate segment, without an inclination, that produces a flat bottom; and a third segment with an inclination to remove the depression again. In this case, the spacing extends over the length of the second segment.

[0108] The RPC, the spacing, and its defined size and geometry, such as its length, help reduce leakage rates. It is assumed that particles may become lodged between the cap and the body as the cap slides over the body, particularly when the spacing between the cap and the body is large. During the sliding of the cap over the body, the gap between the cap and the body may be enlarged and may even remain in the closed state due to particles stuck in the spacing; therefore, powder may leak through this gap. By having a relatively small and defined spacing, the chances of particles becoming lodged between the cap and the body are reduced. The RPC creates a reduced and defined gap between the cap and the edge of the body during the final closure after filling the capsule, which is an important parameter for preventing powder leakage, for example for powders with a large particle distribution. To achieve this, the RPC needs to extend over the entire circumference of the cap.

[0109] If, during the telescopic engagement of the cap with the body, i.e. during the sliding of the cap over the body, interference were to occur between the RPC and the circumference of the body with the MDB, apart from any area formed by the RPC, air would be prevented or at least would have difficulty escaping while the cap slides over the body, thereby making closing of the capsule more difficult or even impossible; in the pre-closed or closed position, the cap is no longer resting on the body, but the capsule can be suddenly opened by the increased pressure in the capsule, which is generated by the air that did not escape during closing but was compressed when the capsule was closed.

[0110] The PRPC is a recess in the RPC. The diameter between the lowest point of the inner surface of the recess formed by the PRPC and a diametrically opposed point on the inner surface of its cap wall can be referred to by the abbreviation DPRPC; the diametrically opposed point on the inner surface of the cap wall can be a point on the inner surface of the RPC or a point on the inner surface of the PRPC. The DPRPC can be 96% to 99% of the MDC, preferably 97% to 99%.

[0111] The recess of the PRPC extends into the cavity formed by the cap, which, during telescopic engagement of the cap with the body, interferes between the lowest point of the inner surface of the recess formed by the PRPC and the outer surface of the body (IDPRPC), wherein the body has its largest outer diameter, preferably the MDB, which may be the RIB. Therefore, during telescopic engagement of the cap with the body, interference may occur between the PRPC and the RIB. During telescopic engagement of the cap with the body, interference may occur between the PRPC and the circumference of the body having the MDB.

[0112] Preferably, the shape of the PRPC and the depth of the recess formed by the PRPC are identical for each PRPC, meaning that all PRPCs are identical in shape and depth. Preferably, the regions of the PRPC have an elliptical shape ranging from equal length and width to one with a length greater than width. Preferably, the length of the PRPC is less than the length of the RPC. Preferably, the width of the PRPC is 80% to 100% of its length, more preferably 82% to 90%. Preferably, the length of the PRPC is 20% to 30% of the length of the RPC, more preferably 22% to 27%. The maximum depth of the recess formed by the PRPC can be 60 to 80 microns.

[0113] IDPRPC can be represented by (MDB-DPRPC) / 2 and can be 10 to 50 microns, preferably 20 to 40 microns. IDPRPC can contribute to PLF and / or SFF.

[0114] The RPC may have, for example, 2, 3, 4, 5, 6, 7, 8, 9, or 10 PRPCs; preferably 4, 5, 6, 7, or 8; more preferably 4, 6, or 8, and even more preferably 6 PRPCs. Preferably, the PRPCs are separated from each other by portions of the RPC having equal widths, meaning that the PRPCs are placed at equal distances from each other throughout the circumference of the RPC. In one embodiment, the RPC may have an even number of PRPCs. The PRPCs may be placed in such a way that two PRPCs always form a pair located on diametrically opposite sides of the PRC.

[0115] Preferably, the PRPC is separated from the beginning and end of the RPC in the x-direction by a portion of the RPC; this means that the PRPC does not extend to either the beginning or the end of the RPC. Preferably, all PRPCs are the same distance from the RIC in the x-direction. In one specific embodiment, the PRPC is located at one-quarter of the length of the RPC closest to the RIC. In another specific embodiment, the center of the PRPC is located between 35% and 65% of the length of the RPC from the beginning of the RPC on the side of the RIC, preferably in the middle of the length of the RPC.

[0116] The PRPC and IDPRPC, resulting from the geometry of the PRPC, such as its depth and also its size, i.e., its length and width relative to the geometry of the RPC, help maintain the cap in the pre-closed position. The PLF is strongly influenced by the geometry of the PRPC. Without a PRPC, the cap would easily fall off the body when in the pre-closed position on the body. This needs to be prevented during any handling of the empty capsule, such as during the filling operation in the filling machine or during printing of any application on the capsule. This is because the empty capsule is handled before the filling step itself, with the cap in the pre-closed position on the body, and the cap needs to remain in this pre-closed position during any handling steps before the actual filling and closing. However, the PLF cannot be too high because once the capsule in the pre-closed position has been filled into the filling machine, the filling machine first opens the capsule by removing the cap from the body. For this removal, the PLF cannot be too high, otherwise the filling machine may no longer be able to open the capsule (i.e., remove the cap from the body), and such unopened capsules become wasted capsules in the filling process. The PRPC, its geometry, and the IDPRPC resulting from its geometry, such as the depth of the PRPC and its size, i.e., the length and width of the PRPC, relative to the geometry of the RPC, are also essential for reducing or keeping the leakage rate low. This is because if the interference caused by the PRPC is again much larger than the gap, i.e., the distance between the RPC and the body, the cap will be enlarged and become too large when sliding over the body, and particles may again become stuck between the cap and the body as the cap slides over the body, thereby counteracting the desired reduction in leakage rate resulting from optimizing the gap by the chosen RPC geometry, as described. For this reason, embodiment A is superior to embodiment B because, in embodiment A, the PRPC in the pre-sealed position is already engaged with the CSB and is no longer located in the area of the CSB. Therefore, when the capsule is filled and is about to be closed by moving the cap from the pre-sealed position to the closed position, the distance between the RPC and the body in embodiment A will be less affected by any interference of the PRPC with the body than in embodiment B.

[0117] The CRC may have a length of 13% to 23% of the length of the cap, preferably 13% to 20%, and more preferably 13% to 17%. The CRC forms a recess in the cap wall within the cavity formed by the cap. At the point of maximum depth of the recess formed by the CRC, i.e., at the lowest point of the inner surface of the CRC in the x-direction, the diameter DCRC between two diametrically opposed points on the inner surface of the CRC is 95% to 97.5% of the MDC. Preferably, this lowest point of the inner surface of the CRC extends over the entire circumference of the CRC; thus, the lowest point is effectively a line, preferably a straight line forming a loop.

[0118] DCRC may be equal to or smaller than DRPC, preferably smaller.

[0119] DCRC may be equal to or smaller than DPRPC, preferably smaller.

[0120] The shape of the longitudinal cut in the CRC in the x-direction may have a curved shape, preferably a concave curved shape, it may have a U-shape or a V-shape, which is preferably the case when the lowest point is actually a straight line forming a loop; preferably a V-shape.

[0121] During the telescopic engagement of the cap and body, an interference (ICRC) occurs between the lowest point of the inner surface of the recess formed by the CRC and the outer surface of the body, where the body has its maximum outer diameter, preferably the MDB, which may be the RIB. The ICRC facilitates SFF. Therefore, during the telescopic engagement of the cap and body, an ICRC may occur between the CRC and the RIB. The ICRC may be 60 to 100 microns.

[0122] In the closed position, the CRC may also engage the CRB with interference; the interference may be 20 to 40 microns.

[0123] In the closed position, the PRPC can engage the CSB.

[0124] In one embodiment, the cap has only one closed loop CRC.

[0125] In one embodiment, the body has only one closed loop CRB.

[0126] When the cap has only one closed loop CRC and the body has only one closed loop CRB of the body, these two closed loops are complementary to each other in the closed position.

[0127] When the cap has only one closed loop CRC and the body has only one closed loop CRB of the body, then this closed loop CRC of the cap engages with the complementary closed loop CRB of the body in the closed position.

[0128] In one embodiment, the regions CSB and CEB of the body do not have inwardly extending protrusions in the form of circumferential rings. Preferably, the regions CSB and CEB of the body do not have any inwardly extending protrusions. More preferably, the region CSB of the body has a continuous and circumferentially flat surface without any protrusions.

[0129] The CEC may have a length of 30% to 45% of the length of the cap, preferably 30% to 40%. The CEC may have any form. In one embodiment, the CEC is dome-shaped.

[0130] At the transition between the CEC and the CRC, the inner diameters of the CEC and the CRC may be the same diameter D-CEC-CRC, ie the CEC and the CRC transition from one to the other without a step change in diameter.

[0131] At the transition between CRC and RPC, the inner diameters of the CRC and RPC may be the same diameter D-CRC-RPC, ie, the CRC and RPC may transition from one to the other without a step change in diameter.

[0132] At the transition between RPC and RIC, the inner diameters of the RPC and RIC may be the same diameter D-RPC-RIC, ie, the RPC and RIC may transition from one to the other without a step change in diameter.

[0133] Between the transition between CRC and RPC and between RPC and RIC, a notch formed by the RPC occurs, ie the diameter between the transition between CRC and RPC and between RPC and RIC decreases relative to the diameters D-CRC-RPC and D-RPC-RIC.

[0134] D-CEC-CRC, D-CRC-RPC and D-RPC-RIC may be the same, and they may be the same as MDC.

[0135] The main part of the body may have a hollow cylindrical shape; this is essentially related to SB1 , SB2 and SB3.

[0136] The hollow cylindrical shape of the main body portion can have a taper, wherein the diameter of the main body portion at the closed end of the body is smaller than the diameter of the main body portion at the open end of the body. Preferably, the taper of the main body portion extends at least across SB1, more preferably across CSB. If the hollow cylindrical portion of the body has a taper, it can also be referred to as the hollow conical portion of the body. Therefore, within the meaning of the present invention, hollow cylindrical shapes also include hollow conical shapes.

[0137] Preferably, any taper of the hollow cylindrical portion of the body is minimal so as to still retain the impression of the substantially hollow cylindrical shape of the CAPSSHELL in the closed position.

[0138] The RIB may have a length of 4% to 8% of the length of the body.

[0139] In one embodiment, the diameter of the RIB may be the same throughout the length of the RIB.

[0140] In another embodiment, the RIB has two adjacent segments along its length, one segment RIBO toward the open end of the body, and one segment RIBC toward the closed end of the body. Where the RIBO and RIBC transition from one to the other, the outer diameters of the RIBO and RIBC may be the same, so there may not be a step change in outer diameter at the transition from RIBO to RIBC. The RIBO may have a taper whereby the diameter of the RIB decreases along the length of the RIBO toward the EB; the EB thus has a smaller diameter than the RIBC. This facilitates alignment of the cap with the body and initiation of telescopic engagement of the cap with the body as the cap slides over the body.

[0141] In one embodiment, the RIBC may have the same diameter throughout its length. Preferably, the diameter of the RIBC is the same as the diameter of the CSB at its end towards the open end of the body.

[0142] In another embodiment, the RIBC may have a taper that reduces its diameter toward the closed end of the body. This is preferably the case when the main portion of the body, in particular the CSB, also has a corresponding taper that reduces the diameter of the CSB toward the closed end of the body. Preferably, the taper of the RIBC may be the same as the taper of the main portion of the body, in particular the CSB. Preferably, the change in the diameter of the RIBC and its taper toward the open end of the body is an extension of and corresponds to the change in the diameter of the CSB toward the open end of the body. Thus, the tapered surface of the RIBC is an extension of the tapered surface of the CSB.

[0143] The RIB may have, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 AVs, preferably 4, 5, 6, 7, 8, 9, 10, 11 or 12 AVs, more preferably 6, 7, 8, 9, 10, 11 or 12 AVs, even more preferably 6, 7, 8, 9, 10 or 11 AVs, especially 6, 7, 8, 9 or 10 AVs. In one embodiment, the RIB may have an even number of AVs, preferably 4, 6, 8, 10 or 12 AVs, more preferably 6, 8 or 10 AVs, even more preferably 8 AVs.

[0144] Preferably, the AVs are separated from each other by portions of the RIB, more preferably by portions of the RIB having equal width. This means that the AVs are preferably placed at equal distances from each other throughout the circumference of the RIB; portions of the RIB are located between the AVs, thereby separating each AV from the adjacent AVs. The AVs may be placed in such a way that two of the AVs always form a pair located on diametrically opposite sides of the RIB; preferably, the number of AVs is even.

[0145] The AV is a recess in the RIB. The recess caused by the AV reduces the diameter of the RIB. The diameter DAV between the lowest point of the outer surface of the recess formed by the AV and the outer surface of the diametrically opposed point of the RIB wall can be 99% to 99.9%, preferably 99.2% to 99.8%, even more preferably 99.3% to 99.7%, and particularly 99.4% to 99.7% of the MDB.

[0146] Preferably, the shape of the area of the AV and the depth of the recess formed by the AV are the same for each AV, which means that all AVs are identical, ie means that the shape and depth of all AVs are the same.

[0147] When the RIB is not tapered, the longitudinal cross-section of the AV may have a rectangular shape. When the RIBC or RIBO is tapered, the longitudinal cross-section of the AV may have a rectangular shape throughout the length of one or more regions of the RIB that are not tapered, and may have a corresponding trapezoidal shape throughout the length of one or more regions of the RIB that are tapered. When both the RIBC and the RIBO are tapered, various portions of the AV may have corresponding trapezoidal shapes.

[0148] The AV is the same length as the RIB. Thus, the AV extends from the EB to the CRB. Preferably, the outer diameter of the CRB at the transition from the RIB to the CRB is the same as the outer diameter of the RIB at that transition, meaning there is no step change in outer diameter at the transition between the RIB and the CRB. Since the CRB is a protrusion into the cavity of the body relative to the RIB, the AV extends to the beginning of the CRB based on their depth: the AV extends into the CRB until the depth of the AV protrusion equals the depth of the CRB protrusion. The AV does not extend into the CSB.

[0149] Preferably, the maximum width of the AV is equal to or less than the length of the AV, preferably, the width of the AV is 85% to 100%, more preferably 90% to 100% of the length of the AV.

[0150] Preferably, the lowest point of the surface of the AV extends over the entire length of the AV; thus, said lowest point is in fact a line, preferably a straight line, which extends in the x-direction.

[0151] Preferably, the surface of the region of the AV is flat.

[0152] To reduce leakage rate, the AVs are not extremely deep but rather shallow, so the size of the DAVs approaches that of the MDBs. When the AVs are relatively shallow, it is preferred that the RIB have more than the typical two AVs typically found in commercial capsules, with the preferred number of AVs being as described herein. A higher number of AVs allows air to escape during capsule closure as the cap slides over the body, even when the AVs are relatively shallow. Furthermore, to reduce leakage rate, it is preferred to have more than two PRPCs on the RIB, in conjunction with optimizing the PLF, with the preferred number of PRPCs being as described herein. Having a different number of PRPCs than the number of AVs, rather than an equal number and equal circumferential distribution of PRPCs and AVs, helps ensure that the PRPCs do not occupy the same circumferential position on the RPC as the AVs on the RIB. This makes it possible for the PRPCs to actually slide through the AVs while the cap slides over the body. This results in greater variation in the PLF: the PLF is lower when the cap and body are aligned such that the PRPCs slide through the AVs, and higher when the PRPCs are not circumferentially aligned with the AVs and therefore do not slide through the AVs when the cap slides over the body. Because it's impractical to align the cap and body with respect to the circumferential positions of the PRPCs and AVs to defined relative positions during filling, such as in a filling machine, the circumferential alignment of the cap relative to the body is arbitrary and can vary from capsule to capsule. It's desirable to have a different number of PRPCs than the number of AVs, and preferably, as described herein, the AVs and PRPCs are separated from each other by equal widths, respectively, by portions of the RIB and RPC. This means that the AVs and PRPCs are preferably positioned at equal distances from each other throughout the circumference of the RIB and RPC, respectively. This reduces potential variations in PLF, as in this arrangement where the distances between each AV and each RPC are equal, but the number of PRPCs and AVs is unequal. It's unlikely that all PRPCs will be circumferentially aligned with the AVs, and as the cap slides over the body, there will always be at least one PRPC that is not circumferentially aligned with the AV and does not slide past it. One such embodiment of the cap and body has a combination of eight AVs and six PRPCs.

[0153] The CRB forms a recess in the body wall within the cavity formed by the body.

[0154] The CRB may have a length of 4% to 8% of the length of the body. At the point of maximum depth of the recess formed by the CRB, i.e., at the lowest point of the outer surface of the CRB in the x-direction, the diameter DCRB between two diametrically opposed points on the outer surface of the CRB is 90% to 98%, more preferably 92% to 98%, even more preferably 94% to 98%, particularly 96% to 98%, and even more particularly 97.5% to 98% of the MDB. Preferably, this lowest point of the outer surface of the CRB extends over the entire circumference of the CRB; thus, the lowest point is effectively a line, preferably a straight line forming a loop.

[0155] Preferably, the diameter of the CRB and the diameter of the RIB are equal at the transition from the CRB to the RIB. This means that there is no step change in diameter at the transition from the CRB to the RIB.

[0156] Preferably, the diameter of the CSB and the diameter of the CRB are equal at the transition from the CSB to the CRB. This means that there is no step change in diameter at the transition from the CSB to the CRB.

[0157] Preferably, the diameter of the CRB decreases without step change in the direction of the end of the body starting from the transition from CRB to RIB until it reaches the point with the maximum depth of the recess formed by the CRB, and then this lowest point increases again without step change in the direction of the end of the body until it reaches the transition from CRB to CSB.

[0158] Preferably, the shape of the longitudinal cut in the CRB in the x-direction may have a curved shape, preferably a concave curved shape, it may have a U-shape or a V-shape, which is preferably the case when the lowest point is actually a straight line forming a loop; preferably a U-shape.

[0159] The combined length of the CSB and CEB may be 85% to 90% of the length of the main body.

[0160] Optionally, the CSB may have one or more protrusions corresponding to the PRPC, which engage with the PRPC in the closed position. The protrusion may be a ring in the form of a notch extending over the entire circumference of the body. Preferably, the engagement is without interference between the PRPC and the optional protrusion.

[0161] The CEB may have any form. In one embodiment, the CEB is dome-shaped.

[0162] Preferably, the cap has four consecutive segments SC0, SC1, SC2 and SC3.

[0163] Preferably, the body has four consecutive segments SB0, SB1, SB2 and SB3.

[0164] Preferably,

[0165] SC0 is CEC;

[0166] SC1 is CRC;

[0167] SC2 is RPC;

[0168] SC3 is RIC.

[0169] Preferably,

[0170] SB0 is CEB;

[0171] SB1 is CSB;

[0172] SB2 is CRB;

[0173] SB3 is RIB.

[0174] The cap and body of the CAPSSHELL may each be formed from elastic walls.

[0175] The elasticity provides for avoiding any breakage of the cap and / or the body during telescopic engagement of the cap with the body, in particular when interference occurs.

[0176] CASPSHELL is made of a capsule membrane having a composition FILMCOMP comprising a film-forming polymer FILMPOLYM commonly used for capsule membranes, such as cellulose derivatives, gelatin, pullulan and soluble starch or a soluble starch derivative.

[0177] Typical wall thicknesses of CAPSSHELLs, ie the wall thickness of the capsule membrane, are known to the skilled person and typical values may be 100 or 105 microns and a typical range may be 90 to 110 microns.

[0178] Typical sizes of CAPSSHELLs are known to the skilled person and can be exemplified by the sizes disclosed in the Technical Reference File Hard Gelatin Capsules, 2nd Edition, Capsugel Library, www.capsugel.com. Examples of sizes are 000, 00, 0, 1, 2, 3, 4 or 5.

[0179] FILMCOMP is therefore the composition of CASPSSHELL, cap, body, ie the composition forming the walls of CAPSSHELL, cap and body respectively.

[0180] The cellulose derivative may be hypromellose (hydroxypropyl methylcellulose, HPMC).

[0181] Examples of HPMC include HPMC 2910, which contains about 29% methoxy groups and about 10% hydroxypropoxy groups; HPMC 2906, which contains about 29% methoxy groups and about 6% hydroxypropoxy groups; and HPMC 2208, which contains about 22% methoxy groups and about 8% hydroxypropoxy groups.

[0182] The polymers can be used individually or as a mixture.

[0183] CAPSSHELL may be a hard or soft capsule shell, preferably a hard capsule shell.

[0184] CAPSSHELL may contain water. The water comes from the production process of CAPSSHELL using an aqueous composition, so the water in CAPSSHELL is typically residual water remaining in the CAPSSHELL after drying. The typical water content in CAPSSHELL is 25 wt% or less, preferably less than 20 wt%, more preferably 0 to 14 wt%, even more preferably 1 wt% to 14 wt%, particularly 2 wt% to 14 wt%, and more preferably 3 wt% to 14 wt% water, where wt% is based on the total weight of the CAPSSHELL.

[0185] FILMCOMP may contain additional substances FURTHERSUBST, such as selected from the group consisting of salts, additives such as gelling agents, gelling aids, plasticizers, pH adjusters, sweeteners, acidulants, preservatives, flavorings, binders, thickeners, colorants, and mixtures thereof.

[0186] Possible content of FURTHERSUBST may be 0.025 wt% to 25 wt%, preferably 0.04 wt% to 22 wt%, wt% being based on the total weight of dry CAPSSHELL.

[0187] Examples of salts include sodium salts, potassium salts, ammonium salts, or magnesium salts. Examples of sodium salts include sodium malate, sodium citrate, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium succinate, sodium polyphosphate, sodium pyrophosphate, sodium carbonate, and sodium bicarbonate. Examples of potassium salts include dipotassium hydrogen phosphate, potassium dihydrogen phosphate, potassium acetate, and potassium carbonate. Examples of ammonium salts include ammonium chloride. Examples of magnesium salts include magnesium chloride and magnesium sulfate.

[0188] These salts may be used alone or in combination of two or more thereof.

[0189] The total amount of the salt may be in the range of 0.5 to 30 parts by weight relative to 100 parts by weight of the total amount of FILMPOLYM on a dry weight basis.

[0190] Examples of the gelling agent include, but are not particularly limited to, carrageenan, gellan gum, agar, pectin, gelatin, xanthan gum, locust bean gum, curdlan, alginic acid, sodium alginate, guar gum, gum arabic, glucomannan, tamarind gum, furcellaran, tara gum, and karaya gum.

[0191] The gelling agent is used in an amount of 0 to 10 wt %, and preferably 0 to 5 wt %, based on the dry weight of CASPSSHELL.

[0192] Examples of plasticizers include triethyl citrate, glycerol, D-sorbitol (D-sorbitol / sorbitan solution), D-mannitol, trehalose, vegetable oils (sesame oil, castor oil), medium chain triglycerides, triacetin, phthalates (dioctyl phthalate), phytosterols, propylene glycol, polysorbate, and polyethylene glycol (MacroTarget).

[0193] Examples of the pH adjuster include phosphoric acid, hydrochloric acid, citric acid, glycine, gluconic acid, succinic acid, acetic acid, tartaric acid, lactic acid, fumaric acid, boric acid, maleic acid, sulfuric acid, malic acid, ammonia, hydroxides, amines, and salts thereof.

[0194] Examples of sweeteners include aspartame, acesulfame potassium, amacha powder, liquid sugar, fructose, glucose, reduced maltitol syrup, licorice, xylitol, glycine, glycerin, glycyrrhizic acid, brown sugar, saccharin, sucralose, stevia extract, refined white sugar, refined honey, D-sorbitol, maltitol, maltose, and D-mannitol.

[0195] Examples of the acidulant include adipic acid, itaconic acid, citric acid, trisodium citrate, glucono-delta-lactone, gluconic acid, potassium gluconate, sodium gluconate, succinic acid, monosodium succinate, disodium succinate, sodium acetate, tartaric acid, lactic acid, sodium lactate, acetic acid, phytic acid, fumaric acid, malic acid, and phosphoric acid.

[0196] Examples of preservatives include benzoic acid, sodium benzoate, parahydroxybenzoates, sodium sulfite, sodium dithionite, sodium metabisulfite, potassium metabisulfite, propionic acid, calcium propionate, sodium propionate, styrax extract, artemisia argyi extract, protamine extract, sorbic acid compounds, sodium dehydroacetate, nisin, sulfur dioxide, pectin degradation products, and ε-polylysine.

[0197] Examples of flavoring agents include various essences, spices, mint, menthol, peppermint, cinnamon, anise, and camphor.

[0198] When FILMCOMP is used in edible products, it is suitable for use with sweeteners, acidulants and flavorings.

[0199] Examples of the thickener include alginic acid, alginates, gum arabic, karaya gum, guar gum, gellan gum, tamarind gum, tara gum, tragacanth gum, carrageenan, CMC-Ca, CMC-Na, glucosamine, pullulan, pectin, sodium polyacrylate, methylcellulose, curdlan, and modified starch.

[0200] The strength of the capsule membrane can be improved by using thickeners and binders.

[0201] The colorant may be a dye or pigment having black, white, gray or any color. The term color herein refers to all colors except black, white and gray.

[0202] Another subject of the invention is a method for preparing CASPSHELL by the process PROCFORMCAPS;

[0203] in

[0204] In PROCFORMCAPS, the capsule shell is formed by the solution DIPSOL, which is a solution of FILMPOLYM in water;

[0205] wherein CAPSSHELL and FLIMPOLYM are as defined herein and all embodiments thereof are as defined herein.

[0206] PROCFORMCAPS may be any conventional process known to those skilled in the art for forming capsule shells, such as extrusion, injection molding, casting or dipping, preferably by dipping.

[0207] The CAPSSHELL, i.e. the cap, and the body, i.e. the capsule membrane, are formed by drying the DIPSOL.

[0208] Dip molding can also be called dip coating.

[0209] The cap of a CAPSSHELL manufactured by dip molding is formed by a mold pin having a corresponding geometric shape that complements the desired shape of the cap. The body of a CAPSSHELL manufactured by dip molding is formed by a mold pin having a corresponding geometric shape that complements the desired shape of the body. By using the corresponding mold pins for dip molding, the cap or body is obtained.

[0210] Dip molding includes the following steps:

[0211] 1. Immerse the mold pin of the first of the two parts of CAPSSHELL into DIPSOL;

[0212] 2. allowing a film to form on the mold pin after dipping to provide a film on the mold pin;

[0213] 3. Drying the film on mold pins to provide the first portion of CAPSSHELL; and

[0214] 4. Remove the first portion of the CAPSSHELL shell from the mold pin;

[0215] 5. Repeat steps 1 to 4 using the mold pins from the second section of CAPSSHELL.

[0216] wherein DIPSOL is as defined herein and all its embodiments.

[0217] Step 2 and step 3 can be performed simultaneously.

[0218] After the two parts of the CAPSSHELL are prepared, the two parts can be telescopically engaged with each other to form a capsule.

[0219] The portion of the capsule shell removed from the mold pin may be of a size that is even longer than the target length of the desired portion of the capsule shell, in which case the portion of the capsule shell on the mold pin and after being removed from the mold pin represents the green body, or may also be referred to as the unmachined portion, and is cut to the desired length to provide the desired portion of the capsule shell of the desired length.

[0220] The mold pin may have a temperature PINTEMP for dip molding. In one embodiment, the mold pin has PINTEMP when the mold pin is immersed in DIPSOL, and after immersion, the film is dried on the mold pin.

[0221] PINTEMP can be from ambient temperature to 60°C.

[0222] The temperature of the DIPSOL during immersion of the mold pin in the DIPSOL may be from ambient temperature to 75°C, preferably from 20°C to 75°C, more preferably from 20°C to 70°C, even more preferably from 20°C to 65°C.

[0223] The film on the mold pins can be dried by air drying. Drying can be carried out at an elevated temperature.

[0224] The drying temperature of the film on the die pins can be from ambient temperature to 60°C, preferably from 20°C to 60°C.

[0225] After the two parts are combined to form the capsules, the CAPSSHELL may be further dried; this drying may be carried out at temperatures ranging from ambient temperature to 60°C.

[0226] The typical wall thickness of a CAPSSHELL manufactured by dip molding is substantially the same for each segment or portion of the CAPSSHELL, each segment or portion of the cap, and each segment or portion of the body.

[0227] DIPSOL can be prepared by dissolving FILMPOLYM in water, DISSOL.

[0228] DIPSOL may further comprise FURTHERSUBST; it may be mixed with the water prior to dissolving the FILMPOLYM in water, or it may be mixed with the solution of FILMPOLYM in water.

[0229] DIPSOL contains an amount of FILMPOLYM and any FURTHERSUBST, based on the dry weight of DIPSOL, which is equal to the amount of FILMPOLYM and any FURTHERSUBST, based on the dry weight of CAPSSHELL, in FILMCOMP, ie, in CAPSSHELL.

[0230] The amounts of FILMPOLYM and any FURTHERSUBST are calculated and selected in such a manner as to provide the desired amounts of FILMPOLYM and any FURTHERSUBST in DIPSOL so as to provide the desired amounts of FILMPOLYM and any FURTHERSUBST in FILMCOMP, ie, in CAPSSHELL.

[0231] The amount of FILMPOLYM and any FURTHERSUBST in dry DIPSOL is equal to the corresponding amounts in dry FILMCOMP, ie, in dry CAPSSHELL.

[0232] Another subject of the present invention is a CAPSSHELL filled with a formulation FILLFORMUL comprising an ingredient INGR, which may be an active pharmaceutical ingredient API, a medicament, a nutritional supplement, a nutraceutical, a vitamin, a mineral, a cosmetic, a health food or a mixture thereof;

[0233] wherein CAPSSHELL is as defined herein and all its embodiments are as defined herein.

[0234] Another subject of the invention is the use of a CAPSSHELL filled with a FILLFORMUL, wherein CAPSSHELL and FILLFORMUL are as defined herein, and all their embodiments are also as defined herein.

[0235] The FILLFORMUL may comprise INGR in an amount of 0.05 wt% to 100 wt%, preferably 0.5 wt% to 90 wt%, more preferably 1 wt% to 50 wt%, even more preferably 5 wt% to 30 wt%, the wt% being based on the total dry weight of the FILLFORMUL.

[0236] Examples of pharmaceutical agents or APIs are dihydropyridine derivatives (e.g., nifedipine), antiviral HIV protease inhibitors (e.g., ritonavir, saquinavir), hyperlipidemia therapeutics (e.g., clofibrate), iodine compounds (e.g., sodium iodate, sodium iodide), polyunsaturated fatty acid derivatives (e.g., eicosapentaenoic acid ethyl ester (EPA), docosahexaenoic acid (DHA)), carotenoids (e.g., lycopene, nopal, β-carotene, lutein, lutein), ubiquinones (coenzyme Q) (e.g., ubidecarenone, which is used as a metabolizable cardiotonic),

[0014] The present invention also includes but is not limited to: vitamin D derivatives, such as phenanthene, ... Examples include vitamin A derivatives (e.g., tretinoin, hepatic oil, retinyl palmitate), vitamin A analogs (e.g., etretinate), vitamin D derivatives, vitamin E derivatives (e.g., tocopheryl nicotinate, tocopheryl acetate, calcium tocopheryl succinate), or vitamin K derivatives (e.g., phytonadione (vitamin K1), menaquinone (vitamin K2), menaquinone (vitamin K3), menatetrenone, phytonadione).

[0237] The pharmaceutical agent or API as an INGR can be filled into the CAPSSHELL alone or in combination with any matrix or carrier, additive or excipient. Any type of matrix or carrier, whether fat-soluble or water-soluble, can be used, as long as it does not impair the activity of the pharmaceutical agent or API and does not affect the various physical properties of the CAPSSHELL, such as strength, air permeability, and decomposition or solubility characteristics. Similarly, the matrix itself can be liquid or solid at room temperature, as long as it can be filled into the CAPSSHELL with the help of heating or dilution with other solvents. Examples of such matrices include vegetable oils (e.g., soybean oil, sesame oil, cottonseed oil, olive oil), fatty acid glycerides (e.g., medium-chain triglycerides), propylene glycol, propylene glycol fatty acid esters, polyethylene glycol, polyvinyl pyrrolidone, triacetin, liquid paraffin, polyoxyethylene sorbitan fatty acid esters, sucrose fatty acid esters, ethanol, and purified water, which can be used alone or in combination. Preferred matrices for dissolving fat-soluble pharmaceutical agents or APIs, such as vitamins A, D, E, and K, are vegetable oils or fatty acid glycerides, with medium-chain triglycerides being particularly preferred. In the case of using a water-soluble matrix, it is preferable to provide a protective layer between the capsule shell layer and the drug or API layer or crystallization inhibitor in consideration of the influence on CAPSSHELL.

[0238] The pharmaceutical agent or API to be filled into the CAPSSHELL of the present invention is preferably exemplified by, but not limited to, those in liquid form or those dissolved, suspended, or emulsified in such matrices as listed above. The pharmaceutical agent or API may also be in a solid form (e.g., powder, granules) or a semi-solid form (e.g., cream or gel). BRIEF DESCRIPTION OF THE DRAWINGS

[0239] The present invention will be described again with reference to the accompanying drawings, in which:

[0240] Figure 1 : A schematic cross-sectional view of a first embodiment of the body of CAPSSHELL is shown.

[0241] Figure 2 : A schematic cross-sectional view showing a second embodiment of the body of CAPSSHELL.

[0242] Figure 3 : A schematic cross-sectional view of a first embodiment of a cap of CAPSSHELL is shown.

[0243] Figure 4 : A schematic cross-sectional view showing a second embodiment of the cap of CAPSSHELL.

[0244] Figure 5 : Shown in closed position Figure 4 The covering in Figure 2 The coverage on.

[0245] Figure 6 : Shown in the pre-closed position Figure 4 The covering in Figure 2 The coverage on.

[0246] Figure 7 : Shown in closed position Figure 3 The covering in Figure 2 The coverage on.

[0247] Figure 8 : Shown in the pre-closed position Figure 3 The covering in Figure 2 The coverage on.

[0248] Figure 9 : Shows the top view of EB.

[0249] Detailed Description of the Preferred Embodiments

[0250] The present invention will now be described in more detail with reference to the accompanying drawings. The same components and arrangements are indicated by the same reference numerals in the drawings, and the corresponding descriptions may be omitted to avoid redundancy.

[0251] Figure 1 An embodiment of a body 1 having four segments CEB 10 , CSB 11 , CRB 12 and RIB 13 is shown.

[0252] CEB 10 is dome-shaped. CSB 11 is a hollow cylindrical section of a body with a taper that increases its diameter from the closed end of CEB 10 toward the open end of the body. CRB 12 extends over the entire circumference of the body. Its cross-section in the x-direction has a U-shape. Line 120 indicates the lowest point of CRB 12, i.e., the point where the recess of CRB 12 has the greatest depth. RIB 13 has AV 14. Figure 1Three AVs 14 are shown. Line 140 indicates the lowest path of the AV 14, i.e., the line where the recess of the AV 14 has the greatest depth. The RIB 13 has two segments: RIBO 130 and RIBC 131. RIBO 130 is the segment of the RIB 13 toward the open end of the main body, and RIBC 131 is the segment of the RIB 13 toward the closed end of the main body. The RIBO 130 tapers in the x-direction, so the diameter of the RIBO 130 decreases in the x-direction toward the open end of the main body. Furthermore, the RIBC 131 tapers in the x-direction, so the diameter of the RIBC 131 decreases in the x-direction toward the closed end of the main body. Where the RIBO 130 transitions to the RIBC 131, the diameters of the RIBO 130 and RIBC 131 are identical, so there is no step in diameter between the RIBO 130 and RIBC 131. EB 15 is the edge of the open end of the main body. The MDB 16 is the diameter at which the RIBO 130 and the RIBC 131 are connected to each other. The AV 14 of the RIB 13 extends from the EB 15 to the beginning of the CRB 12 throughout the entire length of the RIB 13.

[0253] The inclination of the tapers of the CSB 11 and the RIBC 131 is the same. The area of the RIBC 131 is an extension of the area of the CSB 11.

[0254] Figure 2 Another embodiment of the body 1 is shown having four segments CEB 10 , CSB 11 , CRB 12 and RIB 13 .

[0255] CEB 10 is dome-shaped. CSB 11 is a hollow cylindrical section of a body with a taper that increases its diameter from the closed end toward the open end. CRB 12 extends over the entire circumference of the body. Its cross-section in the x-direction has a U-shape. Line 120 indicates the lowest path of CRB 12, i.e., the point where the recess of CRB 12 has the greatest depth. RIB 13 has AV 14. Figure 1Three AVs 14 are shown. Line 140 indicates the lowest path of the AV 14, i.e., the line where the recess of the AV 14 has the greatest depth. The RIB 13 has two segments: RIBO 130 and RIBC 131. RIBO 130 is the segment of the RIB toward the open end of the body, while RIBC 131 is the segment of the RIB 13 toward the closed end of the body. The RIBO 130 tapers in the x-direction, so its diameter decreases in the x-direction toward the open end of the body. The RIBC 131 does not taper in the x-direction, so its diameter remains constant throughout its entire length. Where the RIBO 130 and RIBC 131 transition from one to the other, their diameters remain the same, so there is no step in diameter between them. EB 15 is the edge of the open end of the body. MDB 16 is the diameter of RIBC 131.

[0256] The diameter of the edge of the RIBC 131 is an extrapolation of the x-direction growth diameter of the CSB 11. Thus, the diameter of the edge of the RIBC 131 is the same as the diameter of the edge of the CSB 11 towards the open end of the body.

[0257] Figure 3 An embodiment of a cap 2 having four sections CEC 20, CRC 21, RPC 22 and RIC 23 is shown.

[0258] CEC 20 is dome-shaped. CRC 21 is a closed ring of the cap extending over the entire circumference of cap 2. CRC 21 has a V-shaped cross-section in the x-direction. Line 210 indicates the lowest path of the CRC, i.e., the line where the recess of CRC 21 has the greatest depth. RPC 22 has a U-shaped cross-section in the x-direction. RPC 22 has a protrusion PRPC 24. Figure 1 Four PRPCs 24 are shown, the middle two (PRPC 242 and PRPC 243) are shown in side view, and the top one (PRPC 241) and the bottom one (PRPC 244) are shown in cross-section in the x-direction. PRPC 241 and PRPC 242 are on diametrically opposite sides of the cap relative to each other. Not shown are two additional PRPCs located on diametrically opposite sides of PRPC 242 and PRPC 243, respectively. Thus, Figure 3The cap 2 shown has a total of six PRPCs 24. The area of the PRPC 24 is an elliptical shape with a greater length than width. The cross-section of the PRPC 24 in the x-direction is U-shaped. The PRPCs 24 are positioned throughout the circumference of the cap 2, separated by sections of the RPC 22 and equidistant from one another. All PRPCs 24 are at the same distance from the EC 25. The PRPC 24 is located in the middle of the RPC 22 relative to the x-direction. The RIC 23 does not taper, so the diameter of the RIC 23 is the same throughout its length.

[0259] D-CEC-CRC 2021, diameter of CEC 20 and CRC 21 at the transition from CEC 20 to CRC 21,

[0260] D-CRC-RPC 2122, diameter of CRC 21 and RPC 22 at the transition from CRC 21 to RPC 22,

[0261] D-RPC-RIC 2223, diameter of RPC 22 and RIC 23 at the transition from RPC 22 to RIC 23,

[0262] They are respectively identical, so there is no step change in diameter between the CEC 20 and the CRC 21 , between the CRC 21 and the RPC 22 , and between the RPC 22 and the RIC 23 , which are the MDC 26 .

[0263] Figure 4 Another embodiment of the cap 2 is shown; this embodiment is the same as the cap 2 except that the RPC 24 is located at the first third of the length of the RPC 22 relative to the x-direction of the EC 25. Figure 3 The embodiments shown are identical.

[0264] Figure 5 Shown in closed position Figure 4 The covering in Figure 2 The cap 20 is telescopically engaged with the body 10. The capscell is in the closed position. The PRPC 24 is engaged with the CSB 11. The CRC 21 is engaged with the CRB 12.

[0265] Figure 6 Shown in the pre-closed position Figure 4 The covering in Figure 2 The cap 20 is telescopically engaged with the body 10. The capscell is in the pre-sealed position. The PRPC 24 is engaged with the CSB 11. The CRC 21 is located on the other side of the RIB 13 relative to the CRB 12, that is, the CRC 21 is located on the open end side of the RIB 13.

[0266] Figure 7 Shown in closed position Figure 3 The covering in Figure 2 The cap 20 is telescopically engaged with the body 10. The capscell is in the closed position. The PRPC 24 is engaged with the CSB 11. The CRC 21 is engaged with the CRB 12.

[0267] Figure 8 Shown in the pre-closed position Figure 3 The covering in Figure 2 The cap 20 is telescopically engaged with the body 10. The capscell is in the pre-sealed position. The PRPC 24 is engaged with the CRB 12. The CRC 21 is located on the other side of the RIB 13 relative to the CRB 12, that is, the CRC 21 is located on the open end side of the RIB 13.

[0268] Figure 9 A top view of an EB 15 with six AVs 14 is shown. EB 15 is the cutting edge of RIB 13. The grooves formed by AVs 14 have flat bottoms. The six AVs 14 are three pairs of AVs 14, with the AVs 14 in each pair located on diametrically opposite sides of the EB 15. The AVs 14 are identical in size and shape. All six AVs 14 are separated by sections of RIB 13 of equal width, so the AVs 14 are placed at equal distances from each other throughout the circumference of the RIB 13.

[0269] Examples

[0270] Two designs D1 and D2 are exemplified with the following dimensions and features.

[0271] • The wall thickness of D1 and D2, ie the wall thickness of the capsule membrane, is about 105 microns.

[0272] • The capsule size of D1 and D2 is 0 as disclosed in Technical Reference File Hard Gelatin Capsules, 2nd Edition, Capsugel Library, www.capsugel.com.

[0273] • In the closed position, D1 and D2 have a substantially hollow cylindrical shape, except for the dome-shaped CEC and CEB.

[0274] The average PLF of D1 and D2 is 0.15N.

[0275] The average SFF of D1 and D2 is 5N.

[0276] Cap size:

[0277] • For D1 and D2, the inner length of the cap, ie from the inner surface of the CEC to the cut edge of the RIC, is 10'600 microns.

[0278] • For D1 and D2, the MDC is 7'440 microns.

[0279] Table 1 gives the lengths of the segments as percentages of the length of the cap, the percentages adding up to 100%.

[0280]

[0281]

[0282] Additional sizes of caps:

[0283] DCRC: 96.3% of MDC for D1 and D2

[0284] DRPC: 0.66% of MDC for D1 and D2

[0285] DPRPC: 98.2% of MDC for D1, 98.3% of MDC for D2

[0286] Length of PRPC: 25% of the length of RPC for D1, 23% of the length of RPC for D2

[0287] Width of PRPC relative to its length: 86% for D1; 87% for D2

[0288] The location of PRPC in RPC:

[0289] D1: One quarter of the length of the RPC closest to the RIC

[0290] D2: The center of the PRPC is in the middle of the length of the RPC

[0291] Maximum depth of the notch formed by PRPC: 70 μm for D1, 65 μm for D2

[0292] D1 and D2:

[0293] RPC has 6 PRPCs.

[0294] All PRPCs are identical in shape and depth.

[0295] • The PRPCs are placed at equal distances from each other throughout the circumference of the RPC. The PRPCs are placed in such a way that two PRPCs always form a pair located on diametrically opposite sides of the PRC.

[0296] D-CEC-CRC, D-CRC-RPC, and D-RPC-RIC are the same as MDC.

[0297] • The RPC extends over the entire circumference of the cap.

[0298] Dimensions of the main body:

[0299] • For D1 and D2, the outer length of the body, ie from the outer surface of the CEB to the cutting edge of the RIB, is 18'440 microns.

[0300] • For D1 and D2, the MDB is 7'325 microns.

[0301] Table 2 gives the lengths of the segments as percentages of the length of the body, the percentages adding up to 100%.

[0302] Table 2 [％] [％] D1 D2 Combined length of CEB and CSB 89 89 CRB 5 5 RIB 6 6

[0303] Additional dimensions of the body:

[0304] DCRB: 97.9% of MDB for D1 and D2

[0305] AV:

[0306] DAV: 99.6% of MDB for D1 and D2

[0307] • D1 and D2: The RIB has 8 AVs placed at equal distances from each other throughout the circumference of the RIB in such a way that two of the AVs always form a pair located on diametrically opposite sides of the RIB.

[0308] • The shape of the area of the AV and the depth of the notch formed by the AV are the same for each AV, which means that all AVs are identical, ie means that the shape and depth of all AVs are the same.

[0309] • The length of the AV is the same as that of the RIB, so the AV extends from the EB to the CRB.

[0310] The outer diameter of the CRB at the transition from the RIB to the CRB is the same as the outer diameter of the RIB at the transition, which means that there is no step change in outer diameter at the transition between the RIB and the CRB.

[0311] • The AV extends into the CRB to a point where the depth of the protrusion of the AV equals the depth of the protrusion of the CRB.

[0312] The width of the AV is 90% of the length of the AV.

[0313] D1 and D2:

[0314] • RIB is divided into RIBO with a length of 450 microns and RIBC with a length of 600 microns; RIBO has a taper with an inclination of 23°, resulting in a diameter reduction of 36 microns.

[0315] • The diameter of the CRB and the diameter of the RIB are equal at the transition from the CRB to the RIB.

[0316] The diameter of the CSB and the diameter of the CRB are equal at the transition from the CSB to the CRB.

[0317] Interference between cap and body

[0318] • For D1 and D2, the shape of the RPC throughout its length is a concave curve shape.

[0319] • For D1 and D2, the depth of the gap formed between the RPC and the point of the body with the MDB, which is called the pitch, is 10 microns.

[0320] IDPRPC: 22 microns for D1, 27 microns for D2

[0321] Relative position:

[0322] D1: The PRPC engages the CSB in the pre-sealed position. In the pre-sealed position, the CRC is on the other side of the RIB relative to the CRB, i.e., on the open end of the RIB. The PRPC is positioned within the RPC at a distance in the x-direction from the position of the CRC's minimum diameter that is greater than the x-direction distance between the EB and the end of the CRB adjacent to the CSB.

[0323] D2: The PRPC engages the CRB in the pre-sealed position. In this position, the CRC is on the other side of the RIB relative to the CRB, that is, on the open end of the RIB. The PRPC is positioned within the RPC at a distance in the x-direction from the location of the CRC's minimum diameter that is equal to the distance in the x-direction between the EB and the location of the CRB's minimum diameter.

[0324] D1 in Figure 5 and Figure 6 As shown schematically in the figure, the cap of D1 is Figure 4 As shown schematically in FIG, the main body of D1 is Figure 2 It is schematically shown in FIG.

[0325] D2 in Figure 7 and Figure 8 As shown schematically in FIG, the cap of D2 is Figure 3 As shown schematically in FIG, the main body of D2 is Figure 2 It is schematically shown in FIG.

[0326] D1 and D2:

[0327] • In the closed position, the PRPC engages the CSB.

[0328] • In the closed position, the CRC engages the CRB.

[0329] Reference Signs List

[0330] 1 Main body

[0331] 10 CEB

[0332] 11 CSB

[0333] 12 CRB

[0334] Line 120 indicates the lowest path of the CRB

[0335] 13 RIB

[0336] 130 RIBO

[0337] 131 RIBC

[0338] 14 AV

[0339] 140 lines indicate the lowest path of AV

[0340] 15 EB

[0341] 16 MDB

[0342] 2 caps

[0343] 20 CEC

[0344] 2021 D-CEC-CRC

[0345] 21 CRC

[0346] Line 210 indicates the lowest path of the CRC

[0347] 2122 D-CRC-RPC

[0348] 22 RPC

[0349] 2223 D-RPC-RIC

[0350] 23 RIC

[0351] 24, 241, 242, 243, 244 PRPC

[0352] 25 EC

[0353] 26 MDC

Claims

1. A telescopic capsule shell CAPSSHELL having two separate parts, namely a cap (2) and a body (1), wherein the cap (2) and the body (1) are telescopically engaged with each other to close the CAPSSHELL; The cap (2) has a closed end CEC (20) and an open end; The body (1) has a closed end CEB (10) and an open end; The cap (2) comprises four consecutive segments SC0, SC1, SC2 and SC3 in the x-direction; SC0 contains CEC (20); SC1 comprises a closed ring CRC (21) of the cap (2) in the form of a protrusion extending over the entire circumference of the cap (2); SC2 comprises the protrusion region RPC (22) of the cap (2); SC3 comprises a rim RIC (23) of the open end of the cap (2); The body (1) comprises four consecutive segments SB0, SB1, SB2 and SB3 in the x-direction; SB0 contains CEB (10); SB1 comprises a hollow cylindrical section CSB (11) of the body (1); SB2 comprises a closed ring CRB (12) of the body (1) in the form of a protrusion extending over the entire circumference of the body (1); SB3 comprises a rim RIB (13) of the open end of the body (1); There are at least two protrusions PRPC (24) in the RPC (22), the protrusions being separated from each other by portions of the RPC (22) in the circumferential direction of the cap (2); The closed position is the position where the cap (2) is fully engaged with the body (1) so that the CASPSHELL is closed. In the closed position, the CRC (21) engages the CRB (12); Any protrusion of the CAPSSHELL extends inwardly into the cavity of the cap (2) or the body (1), respectively; When the cap (2) is telescopically engaged with the body (1) in the direction of its length, the extension of the CAPSSHELL is designated as the x-direction; It is characterized by There are at least two vents AV (14) in the form of projections in the RIB (13), which are separated from each other and extend from the edge EB (15) of the open end of the body (1) to the CRB (12), but do not extend into the CSB throughout the entire length of the CRB; and The RPC (22) extends over the entire circumference of the cap (2).

2. The CAPSSHELL of claim 1, wherein The maximum inner diameter MDC (26) of the cap (2) is the maximum inner diameter of the RIC (23).

3. CAPSSHELL according to claim 1 or 2, wherein The maximum outer diameter MDB (16) of the body (1) is the maximum outer diameter of the RIB (13).

4. CAPSSHELL according to claim 1 or 2, wherein The PRPC (24) engages the CSB (11) in the pre-sealed position.

5. CAPSSHELL according to claim 1 or 2, wherein In the pre-sealed position, the CRC (21) is located on the other side of the RIB (13) relative to the CRB (12).

6. CAPSSHELL according to claim 1 or 2, wherein The PRPC (24) is arranged in the RPC (22) at a distance in the x-direction from the position of the minimum diameter of the CRC (21), the distance being greater than the distance in the x-direction between the EB (15) and the end of the CRB (12) adjacent to the CSB (11).

7. CAPSSHELL according to claim 1 or 2, wherein The PRPC (24) engages the CRB (12) in the pre-sealed position.

8. The CAPSSHELL according to claim 1 or 2, wherein In the pre-sealed position, the CRC (21) is located on the other side of the RIB (13) relative to the CRB (12).

9. The CAPSSHELL according to claim 1 or 2, wherein The PRPC (24) is arranged in the RPC (22) at a distance in the x-direction from the position of the minimum diameter of the CRC (21), the distance being equal to the distance in the x-direction between the positions of the minimum diameters of the EB (15) and the CRB (12).

10. The CAPSSHELL according to claim 1 or 2, wherein The shape of the longitudinal cut of the notch formed by the RPC (22) in the x-direction is a curved shape.

11. The CAPSSHELL according to claim 1 or 2, wherein During telescopic engagement of the cap (2) with the body (1), no interference occurs between the RPC (22) and the circumference of the body (1) with the MDB (16) except in any area formed by the PRPC (24); Interference means that the diameter between two diametrically opposed points of the inner surface of the cap (2) is smaller than the MDB (16), which may be the maximum outer diameter of the RIB (13).

12. The CAPSSHELL according to claim 1 or 2, wherein During telescopic engagement of the cap (2) with the body (1), interference occurs between the PRPC (24) and the circumference of the body (1) with the MDB (16); The interference is as defined in claim 7.

13. The CAPSSHELL according to claim 1 or 2, wherein The RPC (22) has 2, 3, 4, 5, 6, 7, 8, 9 or 10 PRPCs (24).

14. The CAPSSHELL according to claim 1 or 2, wherein The PRPCs (24) are placed at equal distances from each other throughout the circumference of the RPC (22).

15. The CAPSSHELL according to claim 1 or 2, wherein All of the PRPCs (24) are identical in shape and depth.

16. The CAPSSHELL according to claim 1 or 2, wherein The PRPC (24) is separated from the beginning and end of the RPC (22) in the x-direction by a portion of the RPC (22).

17. The CAPSSHELL according to claim 1 or 2, wherein All of the PRPCs (24) have the same distance from the RIC (23) in the x-direction.

18. The CAPSSHELL according to claim 1 or 2, wherein The shape of the longitudinal cut of the CRC (21) in the x-direction has a U-shape or a V-shape.

19. The CAPSSHELL according to claim 1 or 2, wherein During the telescopic engagement of the cap (2) with the body (1), an interference ICRC occurs between the CRC (21) and the RIB (13) during the telescopic engagement of the cap (2) with the body (1).

20. The CAPSSHELL of claim 1 or 2, wherein In the closed position, the CRC (21) engages the CRB (12) using interference.

21. The CAPSSHELL of claim 1 or 2, wherein In the closed position, the PRPC (24) engages the CSB (11).

22. The CAPSSHELL of claim 1 or 2, wherein The RIB (13) has two adjacent segments throughout its length, a segment RIBO (130) towards the open end of the body (1) and a segment RIBC (131) towards the closed end of the body (1); the RIBO (130) has a taper by which the diameter of the RIB (13) decreases throughout the length of the RIBO (130) towards the EB (15).

23. The CAPSSHELL of claim 1 or 2, wherein The RIB (13) has 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 AVs (14).

24. The CAPSSHELL of claim 1 or 2, wherein The AVs (14) are placed at equal distances from each other throughout the circumference of the RIB (13).

25. The CAPSSHELL of claim 1 or 2, wherein The shape and depth of all said AVs (14) are identical.

26. The CAPSSHELL of claim 1 or 2, wherein The longitudinal cutout of the CRB (12) in the x-direction has a U-shape or a V-shape.

27. The CAPSSHELL of claim 1 or 2, wherein The cap (2) and the body (1) of the CAPSSHELL are each formed by an elastic wall.

28. The CAPSSHELL of claim 1 or 2, wherein CASPSHELL is made of a capsule membrane having the composition FILMCOMP, which contains a film-forming polymer FILMPOLYM commonly used in capsule membranes.

29. The CAPSSHELL according to claim 28, wherein the film-forming polymer FILMPOLYM is a cellulose derivative, gelatin, pullulan and soluble starch or a soluble starch derivative.

30. The CAPSSHELL of claim 1 or 2, wherein CAPSSHELL is a hard capsule shell.

31. A method for preparing CASPSHELL by process PROCFORMCAPS; in In PROCFORMCAPS, the capsule shell is formed by the solution DIPSOL, which is a solution of FILMPOLYM in water; wherein CAPSSHELL is as defined in claim 1 and FLIMPOLYM is as defined in claim 28.

32. A CAPSSHELL filled with a FILLFORMUL containing an ingredient INGR, wherein the INGR may be an active pharmaceutical ingredient (API), a medicament, a nutritional supplement, a nutraceutical, a vitamin, a mineral, a cosmetic, a health food, or a mixture thereof; Wherein CAPSSHELL is as defined in claim 1.

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