CA2205553C - Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process - Google Patents
Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process Download PDFInfo
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- CA2205553C CA2205553C CA002205553A CA2205553A CA2205553C CA 2205553 C CA2205553 C CA 2205553C CA 002205553 A CA002205553 A CA 002205553A CA 2205553 A CA2205553 A CA 2205553A CA 2205553 C CA2205553 C CA 2205553C
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- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
Abstract
A process for encapsulation of caplets in a capsule comprises the following steps: a) providing empty capsule parts; b) filling at least one of said capsule parts with one or more caplets; c) putting said capsule parts together, and d) treating the combined parts by cold shrinking. The solid dosage forms obtainable by such a process are tamper-proof in that they cannot be opened in a way to be reassembled without showing such opening process.
Description
PROCESS FOR ENCAPSULATION OF CAPLETS IN A CAPSULE
AND SOLID DOSAGE FORMS OBTAINABLE BY SUCH PROCESS
Field of the Invention The present invention relates to a process for encapsulation of caplets in a capsule and to solid dosage forms obtainable by such a process, and more particularly, to the manufacture of a tamper-proof capsule containing a pharmaceutically active composition.
Background of the Invention Various oral medications have been manufactured in the form of so called caplets, which can be swallowed by patients during their regiment of taking medication.
Caplets, however, are not as easily swallowed by patients as capsules having, for example, a gelatin coating.
Additionally, capsule coatings are desirable over caplets since the coatings provide a neutral taste in contrast to caplets per se which sometimes contain pharmaceutical substances that taste, for example, bitter. Thus, patients, in particular children, refuse to swallow such caplets per se. Attempts have therefore been made to encapsulate caplets in a capsule by means of a gelatin cover.
U.S. Patent No. 4,867,983 to Berta describes a method for double dipping gelatin coated caplets. The method provides a procedure for coating solid cores, such as caplets, with a first gelatinous coating on one end, and then with a second gelatinous coating on the other end which is thicker than the first, to simulate the interlocking halves of a hollow capsule. The second, thicker gelatinous coating can be provided with a single gelatin coating from a bath having a higher viscosity than the bath used to provide the first gelatinous coating. Alternatively, the second gelatinous coating can be provided by double dipping to provide layers of gelatinous material or gelatin. This known coating is disadvantageous in that the gelatinous coating and the color distribution is not uniformly distributed over the caplets by this process. Moreover, an overlapping of the different coatings results in color changes of the coatings. Additionally, the dip margins obtained by the known process tend not to be straight. Furthermore, the coatings according to the above patent chip off under stress if the coated caplets are stored under dry conditions and/or high temperature. Finally, the dip coating process of U.S. Patent No. 4,867,983 is time consuming and expensive.
From U.S. Patent No. 5,081,822 to Boyd et al, an automatic caplet filler is known for filling normal gelatin capsules with caplets. The capsules formed by this automatic caplet filler, however, are disadvantageous in that they can be easily manipulated.
Sealing of the capsules has to be effected by means of an additional gelatin strip or by gluing of the caplets in the capsule with an adhesive, as e.g. described in U.S.
Patent No. 4,928,840 or European Patent Application No.
0435726. This further treatment of the capsules may have the effect that substances other than the medication are encapsulated in the capsule. If on one hand a water-based adhesive is used for gluing the capsule halves together, the capsule as well as the caplet may be deformed. If on the other hand, an adhesive containing an organic solvent is used, a brittleness of the capsule will be the result.
Finally, if the capsule halves are connected with each other by means of a heat shrinking process, a visible gap will remain between the capsule halves.
It is therefore the object of the present invention to provide a method for encapsulating caplets in a capsule in a tamper-proof form. It is yet another object of the invention to provide a cost-effective process for easily manufacturing tamper-proof solid dosage forms. It is yet another object of the present invention to provide a solid dosage form comprising a caplet covered by a capsule. It is yet another object of the present invention to provide a pharmaceutical dosage form having a greater resistance to breaking than known products. A
further object of the present invention is to provide a tamper-proof solid dosage form.
Summary of the Invention According to a first aspect, the present invention provides a process for encapsulation of a caplet in a capsule by cold shrinking together capsule parts, which are filled with a caplet. According to another aspect, the present invention provides a solid dosage form obtainable by such a process. The solid dosage form according to the present invention is tamper-proof in that the caplet contained in the capsule cannot be removed from the capsule without destroying same.
The process according to the present invention furthermore provides a capsule product comprising several parts, which are combined with each other in a way that no visible slits between the capsule parts are present after the cold shrink procedure. The solid dosage forms of the present invention have a completely smooth surface, so that same can be swallowed easily by patients.
AND SOLID DOSAGE FORMS OBTAINABLE BY SUCH PROCESS
Field of the Invention The present invention relates to a process for encapsulation of caplets in a capsule and to solid dosage forms obtainable by such a process, and more particularly, to the manufacture of a tamper-proof capsule containing a pharmaceutically active composition.
Background of the Invention Various oral medications have been manufactured in the form of so called caplets, which can be swallowed by patients during their regiment of taking medication.
Caplets, however, are not as easily swallowed by patients as capsules having, for example, a gelatin coating.
Additionally, capsule coatings are desirable over caplets since the coatings provide a neutral taste in contrast to caplets per se which sometimes contain pharmaceutical substances that taste, for example, bitter. Thus, patients, in particular children, refuse to swallow such caplets per se. Attempts have therefore been made to encapsulate caplets in a capsule by means of a gelatin cover.
U.S. Patent No. 4,867,983 to Berta describes a method for double dipping gelatin coated caplets. The method provides a procedure for coating solid cores, such as caplets, with a first gelatinous coating on one end, and then with a second gelatinous coating on the other end which is thicker than the first, to simulate the interlocking halves of a hollow capsule. The second, thicker gelatinous coating can be provided with a single gelatin coating from a bath having a higher viscosity than the bath used to provide the first gelatinous coating. Alternatively, the second gelatinous coating can be provided by double dipping to provide layers of gelatinous material or gelatin. This known coating is disadvantageous in that the gelatinous coating and the color distribution is not uniformly distributed over the caplets by this process. Moreover, an overlapping of the different coatings results in color changes of the coatings. Additionally, the dip margins obtained by the known process tend not to be straight. Furthermore, the coatings according to the above patent chip off under stress if the coated caplets are stored under dry conditions and/or high temperature. Finally, the dip coating process of U.S. Patent No. 4,867,983 is time consuming and expensive.
From U.S. Patent No. 5,081,822 to Boyd et al, an automatic caplet filler is known for filling normal gelatin capsules with caplets. The capsules formed by this automatic caplet filler, however, are disadvantageous in that they can be easily manipulated.
Sealing of the capsules has to be effected by means of an additional gelatin strip or by gluing of the caplets in the capsule with an adhesive, as e.g. described in U.S.
Patent No. 4,928,840 or European Patent Application No.
0435726. This further treatment of the capsules may have the effect that substances other than the medication are encapsulated in the capsule. If on one hand a water-based adhesive is used for gluing the capsule halves together, the capsule as well as the caplet may be deformed. If on the other hand, an adhesive containing an organic solvent is used, a brittleness of the capsule will be the result.
Finally, if the capsule halves are connected with each other by means of a heat shrinking process, a visible gap will remain between the capsule halves.
It is therefore the object of the present invention to provide a method for encapsulating caplets in a capsule in a tamper-proof form. It is yet another object of the invention to provide a cost-effective process for easily manufacturing tamper-proof solid dosage forms. It is yet another object of the present invention to provide a solid dosage form comprising a caplet covered by a capsule. It is yet another object of the present invention to provide a pharmaceutical dosage form having a greater resistance to breaking than known products. A
further object of the present invention is to provide a tamper-proof solid dosage form.
Summary of the Invention According to a first aspect, the present invention provides a process for encapsulation of a caplet in a capsule by cold shrinking together capsule parts, which are filled with a caplet. According to another aspect, the present invention provides a solid dosage form obtainable by such a process. The solid dosage form according to the present invention is tamper-proof in that the caplet contained in the capsule cannot be removed from the capsule without destroying same.
The process according to the present invention furthermore provides a capsule product comprising several parts, which are combined with each other in a way that no visible slits between the capsule parts are present after the cold shrink procedure. The solid dosage forms of the present invention have a completely smooth surface, so that same can be swallowed easily by patients.
More specifically, a process for encapsulating caplets in a capsule is provided, which comprises the following steps:
a. providing empty capsule parts, b. filling at least one of said capsule parts with one or more caplets, c. putting said capsule parts together, and d. treating the combined capsule parts by cold shrinking.
Moreover, a solid dosage form comprising a caplet and a capsule coating obtainable by such process is described.
Description of Preferred Embodiments of the Invention The capsule shell in which the caplet is to be enclosed preferably comprises two shell halves, a body portion and a cap portion. Other capsules comprising more than two parts are also possible. The capsule is typically a hollow shell of generally cylindrical shape having a diameter and length sufficient so that the caplet fits appropriately in the empty capsule. The clearance of the capsule shell and the caplet is preferably about + 0.5 mm. According to a specifically preferred embodiment of the present invention, the clearance of the capsule shell and the caplet is in the range of from about 0 to to about -0.5 mm, which means that the caplet is compressed in the capsule.
A specifically preferred process of the present invention is carried out as follows. Empty capsule shell parts are either kept after production at humid 30 conditions in the range of from about 40 to about 90 %, particularly from about 60 to about 80 %, relative humidity to retain a moisture content of from about 16 to about 18 % by weight of the capsule shell or are re-hu:midified to said moisture content before feeding into a capsule filling machine.
'The first capsule shell. part: is then kept under humid conditions within the filling machine at said moist-ure content during rectifying and assembling with a caplet having a moisture content in the range of from about 0 to about 12 % by weight.
A second or further capsule shell part is processed in the same manner as the first one. Finally, t:ze encapsulated dosage form is dried at a relative humidity in the range of from about 20 to about 40 % and a temperature in the range of from about 15 to about 60 C, preferably from about 15 to about 40 C, more preferably from about 18 to about 25 C.
Caplets having a low moisture content of in the range of from about 0 to about 6 % by weight, or more prefe:rably of from about 0 to about: 3 % by weight, are especially suitable to be used in the process of the present invention. Conical ends of the caplet make the insertion of the caplet into one half of the capsule easie:r. After drying and shrinking the capsule parts together, the capsule can be further film coated, which coating may be enteric.
'The capsule shell material can be a hydrophilic polymer, gelatin being the preferred choice. Otller suita;ble capsule shell materials include starch, casein, chitosan, soya bean protein, safflower protein, alginates, geilan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gel.atin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, pol.yvinylacetate-phtalate, polymerisates of acrylic or mthacrylic esters or mixtures thereof. The capsule shell material may furthermore contain from about 0 to about 40 % pharmaceutically acceptable plasticizers based upon the weight of the hydrophilic polymer. The plasticizer which may be employed can be selected from polyethylene glycol, glycerol, sorbitol, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1,2-propyleneglycol, mono-, di, or tri-acetates of glycerol or mixtures thereof.
Additionally, the capsule shell material may contain pharmaceutically acceptable lubricants in the range of from about 0 to about 10% based upon the weight of the hydrophilic polymer. The lubricant may be selected from aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid or silicones or mixtures thereof.
Moreover, the capsule shell material may contain pharmaceutically acceptable coloring agents in the range of from about 0 to about 10 % based upon the weight of the hydrophilic polymer. The coloring agent may be selected from azo-quinophthalone-, triphenylmethane-, xanthene-dyes, iron oxides or hydroxides, titanium dioxide or natural dyes or mixtures thereof. Further suitable coloring agents are sunset yellow, allura red, amaranth, cochineal red, azogeranine, tartrazine, brilliant black, canthaxanthin, patent blue, fast green, brilliant blue, acid green, erythrosine, quinoline yellow, indigotine, curcumin or carbon black.
Furthermore, the capsule shell material may contain pharmaceutically acceptable extenders in the range of from about 0 to about 95 % based upon the weight of the hydrophilic polymer. The extender may be selected from sunflower proteins, soybean proteins, cotton seed proteins, peanut proteins, rape seed proteins, lactose, gum arabic, acrylates or methacrylates, cellulose acetyl phthalates, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl. methylcellulosephthalate, hydroxymethylcellulose, polyvi.nylpyrrolidone, shellac, bentonite, polyvinyl-acetatephtalate, phthalated gelatin, succinated gelatin, agar agar, hydroxyalkyistarc:hes or mixtures thereof.
'.Phe solid pharmaceutical dosage form according to the present invention also may comprise a coatinq selected from cellacephate, polyvinyl acetate phthalate, methacrylic acid polymers, hyproniellose phthalate, hydroxyalkyl methyl cellulose phthalates or mixtures thereof.
The capsule parts of the solid dosage form of the preser.Lt invention may have the same or different lengths and/or the same or different color. In the contact area of the capsule parts, the solid dosage form may be banded or easily dividable. The caplet being contained in the capsule can have a preformed step or groove in the dividing position of the capsule. To furthermore improve the caplet which is contained in the capsule, the caplet can be coated with an acceptable coating for tablet processing. In some cases, uncoated caplets are, however, preferred. A better contact between the inner shells of the capsule parts and the caplets can be obtained by treating the inner shells and/or the surface of the caplet with an adhesive. A suitable technique to apply the adhesive is spraying same on the shells and caplets immediately before assembling same. Suitable adhesives are e.g. tackidex*or an aqueous gelatin solution.
*Trade-mark 7 The solid dosage form according to the present invention may, for example, comprise a pharmaceutically or agrochemically active composition. Furthermore comprised in the solid dosage form can, for example, be a foodstuff or a dyestuff composition. In case the solid dosage form of the present invention contains a.
pharmaceutical composition, the active substance of same can, for example, be selected from betamethason, thioctacid, sotalol, salbutamol, norfenefrin, silymarin, dihydergotamin, buflomedil, etofibrat, indometacin, oxazepam, acetyldigoxin, piroxicam, haloperidol, isosorbide mononitrate, amitriptylin, diclofenac, nifedipin, verapamil, pyritinol, nitrendipin, doxycyclin, bromhexin, methylprednisolon, clonidin, fenofibrat, allopurinol, pirenzepin, levothyroxin, tamoxifen, metildigoxin, o-(B-hydroxyethyl)-rutoside, propicillin, aciclovirmononitrat, paracetamol, naftidrofuryl, pentoxifyllin, propafenon, acebutolol, 1-thyroxin, tramadol, bromocriptin, loperamid, ketotifen, fenoterol, ca-dobelisat, propranolol, minocyclin, nicergolin, ambroxol, metoprolol, B-sitosterin, enalaprilhydrogenmaleate, bezafibrat, isosorbide dinitrate, gallopamil,.xantinolnicotinat, digitoxin, flunitrazepam, bencyclan, dexapanthenol, pindolol, lorazepam, diltiazem, piracetam, phenoxymethylpenicillin, furosemid, bromazepam, flunarizin, erythromycin, metoclopramid, acemetacin, ranitidin, biperiden, metamizol, doxepin, dipotassium-chlorazepat, tetrazepam, estramustinphosphate, terbutalin, captopril, maprotilin, prazosin, atenolol, glibenclamid, cefaclor, etilefrin, cimetidin, theophyllin, hydromorphon, ibuprofen, primidon, clobazam, oxaceprol, medroxyprogesteron, flecainid, Mg-pyridoxal-5-phosphateglutaminate, hymechromon, etofyllinclofibrat, vincamin, cinnarizin, diazepam, ketoprofen, flupentixol, molsidomin, glibornurid, dimetinden, melperon, soquinolol, P.
dihydrocodein, clomethiazol, clemastin, glisoxepid, kallidinogenase, oxyfedrin, baclofen, carboxymethylcystsin, thioridacin, betahistin, 1-tryptophan, myrtol, bromelaine, prenylamin, salazosulfapyridin, astemizol, sulpirid, benzerazid, dibenzepin, acetylsalicylic acid, miconazol, nystatin, ketoconazol, sodium picosulfate, colestyramin, gemfibrocil, rifampicin, fluorcortolon, mexiletin, amoxicillin, terfenadrin, mucopolysaccharidpolysulfuric acid, triazolam, mianserin, tiaprofensdure, amenziniummetilsulfate, mefloquin, probucol, quinidine, carbamazepin, Mg-l-aspartate, penbutolol, piretanid, amitriptylin, caproteron, sodium valproinate, mebeverin, bisacodyl, 5-amino-salicyclic acid, dihydralazin, magaldrat, phenprocoumon, amantadin, naproxen, carteolol, famotidin, methyldopa, auranofin, estriol, nadolol, levomepromazin, doxorubicin, medofenoxat, azathioprin, flutamid, norfloxacin, fendilin, prajmaliumbitartrate, aescin, acromycin, anipamil, benzocain, B-carotin, cloramphenicol, chlorodiazepoxid, chiormadinonacetat, ciorothiazid, cinnarizin, clonazepam, codein, dexamethason, dicumarol, digoxin, drotaverin, gramicidin, griseofulvin, hexobarbital hydrochiorothiazide, hydrocortison, hydroflumethiazid, ketoproten, lonetil, medazepam, mefrusid, methandrostenolon, sulfaperin, nalidixic acid, nitrazepam, nitrofurantoin, estradiol, papaverin, phenacetin, phenobarbital, phenylbutazon, phenytoin, prednison, reserpin, spironolacton, streptomycin, sulfamethazin, sulfamethizol, sulfamethoxazol, sulfamethoxydiazin, sulfathiazol, sulfisoxazol, testosteron, tolazamid, tolbutamid, trimethoprim, tyrothricin or mixtures thereof.
The purpose of the above description is to illustrate some configurations and uses of the present invention, without implying any limitation. It will be apparent to those skilled in the art that various modifications and variations may be made in the process and product of the invention without departing from the spirit or scope of the invention.
a. providing empty capsule parts, b. filling at least one of said capsule parts with one or more caplets, c. putting said capsule parts together, and d. treating the combined capsule parts by cold shrinking.
Moreover, a solid dosage form comprising a caplet and a capsule coating obtainable by such process is described.
Description of Preferred Embodiments of the Invention The capsule shell in which the caplet is to be enclosed preferably comprises two shell halves, a body portion and a cap portion. Other capsules comprising more than two parts are also possible. The capsule is typically a hollow shell of generally cylindrical shape having a diameter and length sufficient so that the caplet fits appropriately in the empty capsule. The clearance of the capsule shell and the caplet is preferably about + 0.5 mm. According to a specifically preferred embodiment of the present invention, the clearance of the capsule shell and the caplet is in the range of from about 0 to to about -0.5 mm, which means that the caplet is compressed in the capsule.
A specifically preferred process of the present invention is carried out as follows. Empty capsule shell parts are either kept after production at humid 30 conditions in the range of from about 40 to about 90 %, particularly from about 60 to about 80 %, relative humidity to retain a moisture content of from about 16 to about 18 % by weight of the capsule shell or are re-hu:midified to said moisture content before feeding into a capsule filling machine.
'The first capsule shell. part: is then kept under humid conditions within the filling machine at said moist-ure content during rectifying and assembling with a caplet having a moisture content in the range of from about 0 to about 12 % by weight.
A second or further capsule shell part is processed in the same manner as the first one. Finally, t:ze encapsulated dosage form is dried at a relative humidity in the range of from about 20 to about 40 % and a temperature in the range of from about 15 to about 60 C, preferably from about 15 to about 40 C, more preferably from about 18 to about 25 C.
Caplets having a low moisture content of in the range of from about 0 to about 6 % by weight, or more prefe:rably of from about 0 to about: 3 % by weight, are especially suitable to be used in the process of the present invention. Conical ends of the caplet make the insertion of the caplet into one half of the capsule easie:r. After drying and shrinking the capsule parts together, the capsule can be further film coated, which coating may be enteric.
'The capsule shell material can be a hydrophilic polymer, gelatin being the preferred choice. Otller suita;ble capsule shell materials include starch, casein, chitosan, soya bean protein, safflower protein, alginates, geilan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gel.atin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, pol.yvinylacetate-phtalate, polymerisates of acrylic or mthacrylic esters or mixtures thereof. The capsule shell material may furthermore contain from about 0 to about 40 % pharmaceutically acceptable plasticizers based upon the weight of the hydrophilic polymer. The plasticizer which may be employed can be selected from polyethylene glycol, glycerol, sorbitol, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1,2-propyleneglycol, mono-, di, or tri-acetates of glycerol or mixtures thereof.
Additionally, the capsule shell material may contain pharmaceutically acceptable lubricants in the range of from about 0 to about 10% based upon the weight of the hydrophilic polymer. The lubricant may be selected from aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid or silicones or mixtures thereof.
Moreover, the capsule shell material may contain pharmaceutically acceptable coloring agents in the range of from about 0 to about 10 % based upon the weight of the hydrophilic polymer. The coloring agent may be selected from azo-quinophthalone-, triphenylmethane-, xanthene-dyes, iron oxides or hydroxides, titanium dioxide or natural dyes or mixtures thereof. Further suitable coloring agents are sunset yellow, allura red, amaranth, cochineal red, azogeranine, tartrazine, brilliant black, canthaxanthin, patent blue, fast green, brilliant blue, acid green, erythrosine, quinoline yellow, indigotine, curcumin or carbon black.
Furthermore, the capsule shell material may contain pharmaceutically acceptable extenders in the range of from about 0 to about 95 % based upon the weight of the hydrophilic polymer. The extender may be selected from sunflower proteins, soybean proteins, cotton seed proteins, peanut proteins, rape seed proteins, lactose, gum arabic, acrylates or methacrylates, cellulose acetyl phthalates, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl. methylcellulosephthalate, hydroxymethylcellulose, polyvi.nylpyrrolidone, shellac, bentonite, polyvinyl-acetatephtalate, phthalated gelatin, succinated gelatin, agar agar, hydroxyalkyistarc:hes or mixtures thereof.
'.Phe solid pharmaceutical dosage form according to the present invention also may comprise a coatinq selected from cellacephate, polyvinyl acetate phthalate, methacrylic acid polymers, hyproniellose phthalate, hydroxyalkyl methyl cellulose phthalates or mixtures thereof.
The capsule parts of the solid dosage form of the preser.Lt invention may have the same or different lengths and/or the same or different color. In the contact area of the capsule parts, the solid dosage form may be banded or easily dividable. The caplet being contained in the capsule can have a preformed step or groove in the dividing position of the capsule. To furthermore improve the caplet which is contained in the capsule, the caplet can be coated with an acceptable coating for tablet processing. In some cases, uncoated caplets are, however, preferred. A better contact between the inner shells of the capsule parts and the caplets can be obtained by treating the inner shells and/or the surface of the caplet with an adhesive. A suitable technique to apply the adhesive is spraying same on the shells and caplets immediately before assembling same. Suitable adhesives are e.g. tackidex*or an aqueous gelatin solution.
*Trade-mark 7 The solid dosage form according to the present invention may, for example, comprise a pharmaceutically or agrochemically active composition. Furthermore comprised in the solid dosage form can, for example, be a foodstuff or a dyestuff composition. In case the solid dosage form of the present invention contains a.
pharmaceutical composition, the active substance of same can, for example, be selected from betamethason, thioctacid, sotalol, salbutamol, norfenefrin, silymarin, dihydergotamin, buflomedil, etofibrat, indometacin, oxazepam, acetyldigoxin, piroxicam, haloperidol, isosorbide mononitrate, amitriptylin, diclofenac, nifedipin, verapamil, pyritinol, nitrendipin, doxycyclin, bromhexin, methylprednisolon, clonidin, fenofibrat, allopurinol, pirenzepin, levothyroxin, tamoxifen, metildigoxin, o-(B-hydroxyethyl)-rutoside, propicillin, aciclovirmononitrat, paracetamol, naftidrofuryl, pentoxifyllin, propafenon, acebutolol, 1-thyroxin, tramadol, bromocriptin, loperamid, ketotifen, fenoterol, ca-dobelisat, propranolol, minocyclin, nicergolin, ambroxol, metoprolol, B-sitosterin, enalaprilhydrogenmaleate, bezafibrat, isosorbide dinitrate, gallopamil,.xantinolnicotinat, digitoxin, flunitrazepam, bencyclan, dexapanthenol, pindolol, lorazepam, diltiazem, piracetam, phenoxymethylpenicillin, furosemid, bromazepam, flunarizin, erythromycin, metoclopramid, acemetacin, ranitidin, biperiden, metamizol, doxepin, dipotassium-chlorazepat, tetrazepam, estramustinphosphate, terbutalin, captopril, maprotilin, prazosin, atenolol, glibenclamid, cefaclor, etilefrin, cimetidin, theophyllin, hydromorphon, ibuprofen, primidon, clobazam, oxaceprol, medroxyprogesteron, flecainid, Mg-pyridoxal-5-phosphateglutaminate, hymechromon, etofyllinclofibrat, vincamin, cinnarizin, diazepam, ketoprofen, flupentixol, molsidomin, glibornurid, dimetinden, melperon, soquinolol, P.
dihydrocodein, clomethiazol, clemastin, glisoxepid, kallidinogenase, oxyfedrin, baclofen, carboxymethylcystsin, thioridacin, betahistin, 1-tryptophan, myrtol, bromelaine, prenylamin, salazosulfapyridin, astemizol, sulpirid, benzerazid, dibenzepin, acetylsalicylic acid, miconazol, nystatin, ketoconazol, sodium picosulfate, colestyramin, gemfibrocil, rifampicin, fluorcortolon, mexiletin, amoxicillin, terfenadrin, mucopolysaccharidpolysulfuric acid, triazolam, mianserin, tiaprofensdure, amenziniummetilsulfate, mefloquin, probucol, quinidine, carbamazepin, Mg-l-aspartate, penbutolol, piretanid, amitriptylin, caproteron, sodium valproinate, mebeverin, bisacodyl, 5-amino-salicyclic acid, dihydralazin, magaldrat, phenprocoumon, amantadin, naproxen, carteolol, famotidin, methyldopa, auranofin, estriol, nadolol, levomepromazin, doxorubicin, medofenoxat, azathioprin, flutamid, norfloxacin, fendilin, prajmaliumbitartrate, aescin, acromycin, anipamil, benzocain, B-carotin, cloramphenicol, chlorodiazepoxid, chiormadinonacetat, ciorothiazid, cinnarizin, clonazepam, codein, dexamethason, dicumarol, digoxin, drotaverin, gramicidin, griseofulvin, hexobarbital hydrochiorothiazide, hydrocortison, hydroflumethiazid, ketoproten, lonetil, medazepam, mefrusid, methandrostenolon, sulfaperin, nalidixic acid, nitrazepam, nitrofurantoin, estradiol, papaverin, phenacetin, phenobarbital, phenylbutazon, phenytoin, prednison, reserpin, spironolacton, streptomycin, sulfamethazin, sulfamethizol, sulfamethoxazol, sulfamethoxydiazin, sulfathiazol, sulfisoxazol, testosteron, tolazamid, tolbutamid, trimethoprim, tyrothricin or mixtures thereof.
The purpose of the above description is to illustrate some configurations and uses of the present invention, without implying any limitation. It will be apparent to those skilled in the art that various modifications and variations may be made in the process and product of the invention without departing from the spirit or scope of the invention.
Claims (12)
1. A process for the encapsulation of caplets in a capsule to prepare a solid dosage form, comprising the following steps:
a. providing empty first and second capsule shell parts, b. filling at least one of said capsule shell parts with one or more caplets, and c. putting said capsule shell parts together to prepare an encapsulated dosage form, wherein the empty capsule shell parts are either kept after production at humid conditions in the range of from about 40 to 90% relative humidity to retain a moisture content in the range of from about 16 to 18% by weight of the capsule or are re-humidified to said moisture content before feeding into a capsule filling machine and wherein the first capsule shell part is kept under humid conditions within the filling machine at said moisture content during rectifying and assembling with a caplet having a moisture content in the range of from about 0 to about 12 % by weight, the second capsule shell part is processed in the same manner, and the encapsulated dosage form is dried at a relative humidity in the range of from about 20 to about 40% and a temperature in the range of from about 15 to about 60 C and wherein after drying and shrinking of the capsule shell parts the encapsulated dosage form is film-coated to provide the solid dosage form.
a. providing empty first and second capsule shell parts, b. filling at least one of said capsule shell parts with one or more caplets, and c. putting said capsule shell parts together to prepare an encapsulated dosage form, wherein the empty capsule shell parts are either kept after production at humid conditions in the range of from about 40 to 90% relative humidity to retain a moisture content in the range of from about 16 to 18% by weight of the capsule or are re-humidified to said moisture content before feeding into a capsule filling machine and wherein the first capsule shell part is kept under humid conditions within the filling machine at said moisture content during rectifying and assembling with a caplet having a moisture content in the range of from about 0 to about 12 % by weight, the second capsule shell part is processed in the same manner, and the encapsulated dosage form is dried at a relative humidity in the range of from about 20 to about 40% and a temperature in the range of from about 15 to about 60 C and wherein after drying and shrinking of the capsule shell parts the encapsulated dosage form is film-coated to provide the solid dosage form.
2. The process according to claim 1 wherein the caplets comprise a compressed material.
3. A process according to claim 1, wherein an adhesive is sprayed:
a) onto the surface of the caplet, b) onto the inner surface of the first and second capsule shell parts, or c) onto both the surface of the caplet and the inner surface of the first and second capsule shell parts, immediately before assembling.
a) onto the surface of the caplet, b) onto the inner surface of the first and second capsule shell parts, or c) onto both the surface of the caplet and the inner surface of the first and second capsule shell parts, immediately before assembling.
4. A process according to claim 3, wherein the adhesive is tackidex or an aqueous gelatin solution.
5. The process according to claim 1, wherein the encapsulated dosage form is dried at a temperature in the range of from about 18 to about 25 C.
6. The process according to claim 1, wherein the capsule shell parts are maintained at a relative humidity in the range of from about 60 to about 80% during the steps of feeding into a capsule filling machine, rectifying and assembling.
7. Process according to claim 1, wherein the coating is enteric.
8. The process according to claim 1, wherein the moisture content of the caplet is in the range of from about 0 to about 6% by weight.
9. The process according to claim 1, wherein the moisture content of the caplet is in the range of from about 0 to about 3% by weight.
10. The process according to claim 1, wherein the caplet has conical ends.
11. The process according to claim 1, wherein the clearance between the capsule shell part and the caplet is in the range of from 0 to 0.5 mm.
12. Process according to claim 1, wherein the clearance between the capsule shell part and the caplet is in the range of from about 0 to -0.5 mm.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US35813794A | 1994-12-16 | 1994-12-16 | |
| US358,137 | 1994-12-16 | ||
| PCT/US1995/014651 WO1996018370A1 (en) | 1994-12-16 | 1995-11-09 | Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2205553A1 CA2205553A1 (en) | 1996-06-20 |
| CA2205553C true CA2205553C (en) | 2009-04-07 |
Family
ID=23408454
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002205553A Expired - Lifetime CA2205553C (en) | 1994-12-16 | 1995-11-09 | Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process |
Country Status (14)
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|---|---|
| US (1) | US6080426A (en) |
| EP (1) | EP0797424B1 (en) |
| JP (1) | JP3670016B2 (en) |
| KR (1) | KR100468335B1 (en) |
| CN (1) | CN1132566C (en) |
| AT (1) | ATE194486T1 (en) |
| CA (1) | CA2205553C (en) |
| DE (1) | DE69518006T2 (en) |
| DK (1) | DK0797424T3 (en) |
| ES (1) | ES2150017T3 (en) |
| GR (1) | GR3034491T3 (en) |
| MX (1) | MX9703773A (en) |
| PT (1) | PT797424E (en) |
| WO (1) | WO1996018370A1 (en) |
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1995
- 1995-11-09 PT PT95939890T patent/PT797424E/en unknown
- 1995-11-09 KR KR1019970704011A patent/KR100468335B1/en not_active IP Right Cessation
- 1995-11-09 CA CA002205553A patent/CA2205553C/en not_active Expired - Lifetime
- 1995-11-09 AT AT95939890T patent/ATE194486T1/en active
- 1995-11-09 EP EP95939890A patent/EP0797424B1/en not_active Expired - Lifetime
- 1995-11-09 DK DK95939890T patent/DK0797424T3/en active
- 1995-11-09 CN CN95196811A patent/CN1132566C/en not_active Expired - Lifetime
- 1995-11-09 WO PCT/US1995/014651 patent/WO1996018370A1/en active IP Right Grant
- 1995-11-09 JP JP51881996A patent/JP3670016B2/en not_active Expired - Fee Related
- 1995-11-09 ES ES95939890T patent/ES2150017T3/en not_active Expired - Lifetime
- 1995-11-09 DE DE69518006T patent/DE69518006T2/en not_active Expired - Lifetime
- 1995-11-09 MX MX9703773A patent/MX9703773A/en unknown
-
1996
- 1996-01-11 US US08/585,549 patent/US6080426A/en not_active Expired - Lifetime
-
2000
- 2000-09-26 GR GR20000402180T patent/GR3034491T3/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ATE194486T1 (en) | 2000-07-15 |
| DK0797424T3 (en) | 2000-10-23 |
| DE69518006T2 (en) | 2000-12-21 |
| PT797424E (en) | 2000-10-31 |
| ES2150017T3 (en) | 2000-11-16 |
| EP0797424A1 (en) | 1997-10-01 |
| JPH11500326A (en) | 1999-01-12 |
| WO1996018370A1 (en) | 1996-06-20 |
| CN1132566C (en) | 2003-12-31 |
| CA2205553A1 (en) | 1996-06-20 |
| CN1170346A (en) | 1998-01-14 |
| GR3034491T3 (en) | 2000-12-29 |
| EP0797424B1 (en) | 2000-07-12 |
| KR100468335B1 (en) | 2005-09-02 |
| DE69518006D1 (en) | 2000-08-17 |
| KR980700050A (en) | 1998-03-30 |
| MX9703773A (en) | 1997-08-30 |
| JP3670016B2 (en) | 2005-07-13 |
| US6080426A (en) | 2000-06-27 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20151109 |