FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
AND
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(SEE SECTION 10; RULE 13)
PROCESS FOR ENCAPSULATION OF CAPLETS IN A CAPSULE AND SOUD DOSAGE FORMS OBTAINABLE BY SUCH PROCESS
SCITECH CENTRE AN INDIAN COMPANY REGISTERED UNDER THE PROVISIONS OF COMPANIES ACT, 1956. HAVING ADDRESS AT 7, PRABHAT NAGAR JOGESHWARI (WEST) MUMBAI - 400 102, INDIA.
THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THE INVENTION

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 pharmaceutical^ active composition with specially designed capsule and caplet.
BACK GROUND OF THE INVENTION
Various oral medications have been manufactured in the form of so called caplets, which card 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 coating pjrovide 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. PatlNo.4,867,983 to Berta describes a method for double dipping gelatin coated caplets. The method provides a procedure for coating solid cores, such 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 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. Pat. No,4,867$83 is time consuming and expensive.
From U.S. Pat. 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. Pat.No.4,928,840 or European Patent Application No.0435726. This further treatment of the capsules may hav0 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.
In U.S.P^t. no 5317849 Sauter tried to oversome many of the limitations listed above and alsojmodified the process in subsequent patents. Also US 6080426, US 6245350 speaks about the process more in detail, however it was found that product developed by these {processes is not fully tamper proof. The shells get expanded and can be easily removediWhen exposed to high humidity.
It is therefore the object of the present invention to provide a method for encapsulating caplets ih a capsule in a tamper-proof form. It is yet another object of the invention to suggest (modified design of the caplet and the shell covering the caplet. It is yet another object of the invention to provide a cost effective process for easily manufacturing tamper -tproof 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 THjE INVENTION.
According to the 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 special design for caplet arid the shell covering the 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 capsiiiie cannot be removed from the capsule without destroying same.
The proqess 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. filjing 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 capsjule 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 shell 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 maximum up to +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 about -0.5 mm, which means that the caplet is compressed in the capsule.
The capsule shell is having special feature as introduction of groove / indentation etc. This feature is reproduced on the caplet also so as when the shell overlaps over the caplet, the engagement of special features takes place and post shrinkage, makes it impossible to separate with out getting damaged.
The capiet is having special feature as introduction of groove / indentation etc. This feature i£ similar reproduction of the shells and for objective, when the shell overlaps over the; caplet, the engagement of special features takes place and post shrinkage, makes it impossible to separate with out getting damaged.
A specifically preferred process of the present invention is carried out as follows. Empty capsule shell parts with special feature are either kept after production at humid conditions in the range of from about 40 to about 90%, particularly from about 60 to about 8Q%, relative humidity to retain a moisture content of from about 16 to about 18% by weight of the capsule shell or are re-humidified to said moisture content before feeding Into a capsule filling machine.

The first qapsule shell part is then kept under humid conditions within the filling machine at said moisture content during rectifying and assembling with a caplet having similar special feature and 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 matter as the first one. Finally, thle encapsulated dosage form is dried at a relative humidity in the range of from about 20 {to about 50% and a temperature in the range of from about 15 to about 40 C, more preferably from about 18 to about 25 C. The cold shrinking , involves temperatures preferably at or near room temperature.
Caplets have a low moisture content of in the range of from about 0 to about 6% by weight, pr more preferably of from about 0 to about 3% by weight, are especially suitable tp be used in the process of the present invention. Rounded ends of the caplet make thej insertion of the caplet into open half of the capsule shell easier. After drying and shrinking the capsule parts together, the capsule can be further film coated, which coating nrjiay be enteric.
The capsule shell material can be a hydrophilic polymer, gelatin being the preferred choice, Other suitable capsule shell materials include starch, casein, chitosan, soya bean protein, saffower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatgin, cellulosephtalate-acetate, polyvinyl acetate, hydroxypjropyl methylcellulose, polyvinylacetate-phtalate, polymerisates of acrylic or mthacryljc esters or mixtures thereof. The capsule shell material may furthermore contain from about 0 to about 30% pharmaceutical^ 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 mixturfes 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 ojls, 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 hydrophiljc polymer. The coloring agent may be selected from azo-quinophthalone-, triphenylrtnethane-, 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, faslt 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 50% 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,
acrylate^ or methacrylates, cellulose acetyl phthalates, hydroxypropy! methylcellulose,
.hydroxypropyl methyceiluose, hydroxypropyl methylcellulosephthalate,
hydroxytjnethylceltulose, polyvinylpyrrolidone, shellac, bentonite, polyvinyl acetatephtalate, phthalated gelatin, succinated gelatin, agar agar, hydroxy alky I starches or mixtufes thereof.
The solid pharmaceutical dosage form according to the present invention also may comprise a coating selected from cellacephate, polyvinyl acetate phthalate, methacrylic

acid polymers, hypromellose phthalate, hydroxyalkyl methylcellulose phthalates or mixtures thereof.
The capsple parts of the solid dosage form of the present 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, uncoatedi 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 cjf 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 adhesive are e.g. tackidex or an aqueous gelatin solution.
The solid dosage form according to the present invention may, for example, comprise a pharmaceutical^ or agrochemicaliy active composition. Furthermore comprised in the solid dosjage from can, for example, be 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 betamethasone, thioctic acid, sdtalol, salbutamol, norfenefrine, silymarin, dihydroergotamine, buflomedil, etofibrate, indomethactn, oxazepam, acetyldigitoxins, piroxicam, haloperidol, isosorbide mononitrate, amitriptyline, diclofenac, nifedipine, verapamil, pyritinol, nitrendipine, doxycycijne, bromhexine,methylprednisolone, clonidine, fenofibrate, allopurinol, pirenzeplne, levothyroxine, tamoxifen, metidigoxin, o-(B-hydroxyethyl)-rutoside, propicillin, aciclovirmononitrate, paracetamolol, naftidrofuryi, pentoxifylline, propafenone, acebutolol, 1- thyroxim, tramadol, bromocriptine, loperamide, ketofinen, fenoteroj, ca-dobesilate, propranonol, minocycline, nicergoline, ambroxol, metoprolol, B-sitosterini, enaiapriihydrogenmaleate, bezafibrate, isosorbide dinitrate, gallopamiUantinolnicotinate, digitoxin, flunitrazepam, bencyclane, depanthenol,

pindolol, lorazepam, diitiazem, piracetam, phenoxymethylpenicillin, furosemide,
bromazepjam, flunarizine, erythromycin, metoclopramide, acemetacin, ranitidine,
biperiden, metamizol, doxepin, dipotassium-chlorazepet, tetrazepam,
estramus^inephosphate, terbutaiine, captopril, maprotiline, prazosin, atenolol,
glibenclartiid, cefaclor, etilefrin, cimetidine, theophylline, hydromorphone, ibuprofen,
primidone!, ciobazam, oxceproi, medroxyprogesterone, flecainide, Mg-pyridoxal-5-
phosphat0glutaminate, hymechromone, etofyllineclofibrate, vincarnine, cinnarizine,
diazepqrrl, ketoprofen, flupentixol, molsidomine, glibornuride, dimethindene, melperone,
soquinolol, dihydrocodeine, clomethiazole, clemastine, glisoxepid, kallidinogenase,
oxyfedrinfe, baclofen, carboxymethyicystsin, thioredoxin, betahistine, 1-tryptophan,
myrtoi, bromelain, prenylamine, salazosulfapyridine, astemizole, sulpiride,
benzerazpd,dibenzepin, acetylsalicylic acid, miconazole, nystatin,ketoconazole, sodium
picosulfate, colestyramate, gemfibrozil, rifampin, fluocortolone, mexiletine, amoxicillin,
terfenadine, mucopolysaccharidpolysulfuric acid, trizolam, mianserin, tiaprofensaure,
ameziniummethylsulfate, mefloquine, probucol, quinidine, carbamazepine, Mg.-1-
aspartate, penbutolol, piretanide, amitriptyfine, caproteron, sodium valproinate
mebeverjne, bisacodyl, 5-amino-salicycIic acid, dihydralazine, magaldrate,
phenpro((:oumon, amantadine, naproxen, carteolol, famotidine, methyidopa, auranofine,
estriol, nadolol, levemepromazine, doxorubicin, medofenoxat, azathioprine, flutamide,
norfloxacin, fendiline, prajmaliumbitartrate, aescin acromycin, anipamil, benzocaine, B-
carotene, cloramphenicol, chiorodiazepoxide, chlormadinoneacetate, chlorothiazide,
cinnarizine, clonazepam, codeine, dexamethasone, dicumarol, digoxin, drotaverine,
gramicidjne griseofulvin, hexobarbital hydrochlorothiazide, hydrocortisone,
hydroflumethiazide, ketoprofen, lonetil, medazepam, mefruside, methandrostenolone,
sulfapenne, nalidixic acid, nitrazepam, nitrofurantoin, estradiol, papaverine.phenacetin,
Phenobarbital, phenylbutazone, phenytoin, prednisone, reserpine, spironolactine,
streptomycin, Sulfamethizole, sulfamethazine, sulfamethoxoazole,
sulfamefhoxydiazinon, sulfathiazole, sulfisoxazole, testosterone, tolazamide, tolbutamide, 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 ol the invention without departing from the spirit or scope of the invention.
The following examples are provided to illustrate the invention and not intended to limit the scope! thereof.
EXAMPLES
Evaluation methods
Exposureito normal humidity
The caplejts so produces were exposed to 28 deg C and 50 % RH. The outer shell was tried to remove from the caplet by slight twising. Whether the shell can be removed without damage was observed. 20 caplets were tested.
Exposureito high humidity
The caplejts so produces were exposed to 28 deg C and 90 % RH. The outer shell was tried to remove from the caplet by slight twising. Whether the shell can be removed without damage was observed. 20 caplets were tested.
Example-i
Caplets were made as per the design shown in Fig - 1C. The dimensions were such that the clearance between aerated shell as per Fig - 1S was 0.2 mm. The shells as per Fig-2S w$re made out of gelatin as per following composition.


Caplets were made with acetaminophen and as per Fig-1C. The caplets were polished to eliminate the burr on caplets.
The shells so produced were exposed to 25 deg C and 75 % RH for 3 hrs and then pressed over the capiets.
Examples
Caplets Were made as per the design shown in Fig - 2C. The dimensions were such that the Clearance between aerated shell as per Fig - 2S was 0.2 mm. The shells as per Fig-2S wlere made out of gelatin as per following composition.


Capletsiwere made with acetaminophen and as per Fig-2C. The caplets were polished to eliminate the burr on caplets.
The shells so produced were exposed to 25 deg C and 75 % RH for 3 hrs and then pressed over the caplets.
Examp|e-3

Caplets were made as per the design shown in Fig - 3C. The dimensions were such that the clearance between aerated shell as per Fig - 3S was 0.2 mm. The shells as per Fig-3S were made out of gelatin as per following composition.

Caplets were made with acetaminophen and as per Fig-3C, The caplets were polished
to eliminate the burr on caplets .
The shells so produced were exposed to 25 deg C and 75 % RH for 3 hrs and then pressed iover the caplets.

Evaluation
Observation on removal of shells
Summary! table for removal of parts without deformation
Figures oiit of 20


WE CLAIM:-
1. A projcess for the encapsulation of caplets in a capsule, comprising the following steps:
- Providing empty first and second capsule shell parts,
- Filling at least one of said capsule parts with one or more caplets.
- Putting said capsule parts together,
Wherein the empty capsule parts are either kept after production at humid conditions in the range; of from about 40 to90% 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 pjart is kept under humid conditions within the filling machine at said moisture content during rectifying and assembling with caplet having a moisture content in the range of from about 0 to about 12 by weight, the second capsule 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 parts the encapsulated dosage form is film-coated.
2. The process according to claim 1 wherein the caplets comprise a compressed material.
3. The process according to claim 2 where in the caplet have special groove / indentation on its body.
4. The process according to claim 3, wherein the no of grooves can be from 0 to 10 in numbers on caplets

5. The process according to claim 3, wherein the depth of grooves can be from 0.02 to 1,5 mm
6. The process according to claim 3, wherein the profile of grooves can be circular or angular or combinations there of.
7. The process according to claim 1 wherein the capsule parts are of same shape to (hat of caplet being filled.
8. The process according to claim 7 where in the capsule parts have special groove / indentation on its body.
9. The process according to claim 7, wherein the no of grooves can be from 0 to 10 in numbers on capsule parts.
10.The process according to claim 7, wherein the depth of grooves can be from 0.02 to 1.5 mm
11.The process according to claim 3, wherein the profile of grooves can be circular or pngular or combinations there of.
12, A process according to claim 1, wherein an adhesive is sprayed onto the surface of the caplet and/or onto the inner surface of the capsule parts immediately before assembling.

13. A process according to claim 12, wherein the adhesive is tackidex or an aqueous gelatin solution.
14. Th^ 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.
15. The process according to claim 1, wherein the capsule 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.
16. A solid dosage form according to claim 14, wherein the capiet contained in the capsule is uncoated or coated with an acceptable coating for tablet processing.
17. The process according to claim 1, wherein the moisture content of the capiet is in fie range of from about 0 to about 6% by weight.
18.The process according to claim 17, wherein the moisture content of the capiet is in the range of from about 0 to about 3% by weight.
19. The process according to claim 1, wherein the capiet has conical ends.
20.T|e process according to claim 1, wherein the clearance between the capsule part and the capiet is in the range of from 0 to 0.5 mm.
21 Process according to claim 20, wherein the clearance between the capsule part and the capiet is in the range of from about 0 to - 0.5 mm.

22. A solid dosage form obtainable according to the process of claim 1.
23. Process according to claim 1, wherein the coating is enteric.
24. A solid dosage form according to claim 22 comprising a pharmaceutically active composition.
25. A solid dosage form according to claim 22, comprising an agrochemically active composition.
26. A solid dosage form according to claim 15, wherein the capsule part material comprises a hydrophilic polymer.
27. A solid dosage form according to claim 15, wherein the capsule part material is selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginagtes, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin , cellulosephtalate-acetate, potyvinylacetate, hydroxypropyl methlecellulose, polyvinylacetate-phtalate, polymerisates of acrylic or meth-acrylic esters and mixtures thereof.
28. A solid dosage form according to claim 26, wherein the capsule part material contains pharmaceutically acceptable plasticizers in the range of from about 0 to about 40% based upon the weight of the hydrophilic polymer.
29. A solid dosage form according to claim 28, wherein the plasticizer is selected from the group consisting of polyethylene glycol, glycerol, sorbitol, dioctyl-sodium

sultosuccinate, triethyl citrate, tributyl citrate, 1, 2-propyleneglycol, mono-, di- or tri-acetates glycerol and mixtures thereof.
30. A solid dosage form according to claim 26, wherein the capsule part material contains pharmaceutically acceptable lubricants in the range of from about 0 to about 10% based upon the weight of the hydrophilic polymer.
31. A solid dosage form according to claim 30, wherein the lubricant is selected from the group consisting of aluminiumstearate, calciumsterate, magnesiumstearate, tinstearate. talc, sodium lauryl sulfate, lecithins, mineral oils, steric acid or silicones and mixtures thereof.
32. A solid dosage form according to claim 26, wherein the capsule part material contains pharmaceutical acceptable coloring agents in the range of from abut 0 to about 10% based upon the weight of the hydrophilic polymer.
33. A solid dosage form according to claim 32, wherein the coloring agent is selected from the group consisting of azo-, quinophthalone-, triphenylmethane-, xanthene-dyes, iron oxides or hydroxides, titanium dioxide or natural dyes and mixtures thereof.
34. A solid dosage form according to claim 32, wherein the coloring agent is selected from 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.

35. A solid dosage form according to claim 26, wherein the capsule part material contains pharmaceutically acceptable extenders in the range of from about 0 to about 95% based upon the weight of the hydrophilic polymer.
36.A solid dosage form according to claim 1, wherein the capsule part material contains an extender.
37. A solid dosage form according to claim 36, wherein the extender is selected from the group consisting of sun-flower proteins, soybean proteins, cotton seed proteins, peanut proteins, rape seed proteins, lactose, gum arabic, acrylates or methacrylates, cellulose acetyl phthalates, hydroxypropyl cellulose, hydroxypropyl methylceilulose, hydroxypropyl methycellulosephthalate, hydroxymethyl cellulose, polyvinyl pyrrolidone, shellac, bentonite, polyvinyl-acetatephtalate, phthalated gelatin, succinated gelatin, agar agar, hydroxyalkylstarches and mixtures thereof.
38. A solid dosage form according to claim 22, comprising a foodstuff composition.
39. A solid pharmaceutical; dosage form obtainable according to the process of claim 22.
40. A solid pharmaceutical dosage form according to claim 1, comprising a coating setected from the group consisting of cellacephate, poiyviniyl acetate phthalate, methacrylic acid polymers, hypromellose phthalate.hydroxyaikyl methyl cellulose phthalates and mixtures thereof.
41. A solid dosage form according to claim 15, wherein the first and second capsule parts have the same or different lengths.

42. A solid dosage form according to claim 15, wherein the first and second capsule parts have the same or different colors.
43. A solid dosage form according to claim 15, wherein the first and second capsule parts are unmarked or marked with different logos.
44. A solid dosage form according to claim 35, wherein the first and second capsule parts are marked with different color inks/marking solutions.
45. A solid dosage form according to claim 15, wherein the solid dosage form is banded at the contact area of the capsule parts.
46. A siolid dosage form according to claim 15, wherein the solid dosage form is easfly dividable at the contact area of the capsule parts.
47. A solid dosage form according to claim 2, wherein the caplet contained in the capsule has a preformed step or groove so that the solid dosage form may be dividing into separate portions.
48. A solid dosage form according to claim 21, comprising a dyestuff composition.
49. A solid dosage form according to claim 24, wherein the caplet contained in the capsule is a pharmaceutical composition with an active substance selected from the group consisting of betamethasone, thioctic acid, sotalol, salbutamol, nortenefrine, silymarin, dihydroergotamine, buflomedil, etofibrate, indomethacin, oxazepam, acetyldigitoxins, piroxicam, haloperidol, isosorbide mononitrate,

I
am(triptyline, diclofenac, nifedipine, verapamil, pyritinol, nitrendipine, doxycycline,
brolmhexine, methylprednisolone, clonidine, fenof allopurinol, pirenzepine,
levftthyroxine, tamoxif metildigoxin, o-(B-hydroxyethyl)-rutoside, propicillin,
achblovirmononitrate, paracetamolol, naftidrofuryl, pentoxifylline, propafenone,
acejbutolol, 1-thyroxin, tramadol, bromocriptine, loperamide, ketofinon, feneterol,
ca-jfobesiiate, propranolol, minocycline, nicergoline, ambroxol, metoprolol, B-
sitqsterin , enalaprilhydrogenmaleate, bezefibrate, isosorbide din'rtrate,
gallopamil, xantinoinicotinate, digitoxin, flunitrazepam, bencyclane,
de^panthenol, pindolol, Iorazepam, diltiazem, piracetam, phenoxymethyl
penicillin, furosemide, bcomazepam, ttunarizine, erythromycin., metaclopramide,
acemetacin, ranitidine, biperiden, metamizol, doxepin, dipotassium-chlorazepat,
tetrazepam, estramustinephosphate, terbutaline, captopril, maprotiline, prazosin,
atenolol, glibenclamid, cefaclor, entilefrin.cimetidine, theophylline,
hydiromorphone, ibuprofen , primidone, clobazam, oxaceprol,
medroxyprogesterone, flecainide, Mg.- pyridoxal-5 -phosphateglutaminate,
hyniechromone, etofyllineclofibrate, vincamine, cinnarizine, diszepam,
ket^profen, flupentixol, molsidomine, glibornuride, dimethindene, melperone,
soqyinolol, dihydrocodeine, clomethiazole, clemastine, glisoxepid,
kallidinogenase, oxyfedrine, baclofen, carboxymethylcystsin, thioredoxin,
betihistine, 1-tryptophan, myrtol, bromelain, prenylamine, salazosulfapyridine,
astemizole, sulpiride, benzerazid,.dibenzepin, acetylsalicylic acid, miconazole,
nystatin, ketoconazole, sodium picosulfate, colestyramate, gemfibrozil, rifampin,
fluocortolone, mexiletine, amoxicillin, terfenadine,
mucopolysaccharidpolysulfuricacid, triazolam, mianserin, tiaprofensaure, ameziniummethylsuifate, mefloquine probucol, quinidine, carbamazepine, Mg-1-aspartate, penbutolol, piretanide, amitriptyline, caproteron, sodium valproinate, mebeverine, bisacodyl, 5-amino-salicyclic acid, dihydralazine, magaldrate, phenprocoumon, amantadine, naproxen, carteolol, famotidine, methyldopa, auranofine, estriol, nadolol, levomepromazine, doxorubicin, medofenoxat, azathioprine, flutamide, norfloxacin, fendiline, prajmaliumbitartrate, aescin acrcomycin, anipamil, benzocaine, B-carotene, cloramphenicol, chlorodiazepoxid,

chlormadinoneacetate, chlorothiazide, cinnarizine, clonazepam, codeine, dexamethasone, dicumarol, digoxin, drotaverine, gramicidine, griseofulvin, hexobarbital hydrochlorothiazide, hydrocortisone, hydroflumethiazide, ketoprofen, lonetil, medazepam, mefruside, methandrostenolone, sulfaperine, nalidixic acid, nitrazepam, nitrofurantoin, estradiol, papaverine, phenacetin, Ph$nobarbital, phenylbutazone, phenytoin, prednisone, reserpine, spironolactine, styreptomycin, sulfamethizole, sulfamethazine, sulfamethoxoazole, sulfamethoxydiazinon, sulfathiazole, sulfisoxazole, testosterone, tolazamide, tolbutamide, trimethoprim, tyrothricin or mixtures thereof.

M.S.Khadilkar (Agent for the applicants) Patent Agent no. IN/PA 391 (E-mail:- info@k2ipr.com)
Dated this! 28th day of October, 2009