JPH01283219A - Solid rapid collapsible administration form - Google Patents

Abstract

PURPOSE: To obtain a foamable tablet for preparing an aqueous suspension of diclofenac (salt) suitable for oral administration by containing a fine granular diclofenac having a water-permeable swelling coating substance and an excipient suitable for a solid foamable formulation. CONSTITUTION: This foamable tablet contains a superfine pulverized diclofenac (salt) having <=200μm, especially <=100μm average particle diameter and having a water-permeable swelling coating substance composed of polyvinyl pyrrolidone, a lower alkyl ether of cellulose and a permeable and swelling acrylate/ methacrylate copolymer, etc., an excipient suitable for a solid foamable formulation (a reagent acting as a source of carbon dioxide and a reagent inducing release of carbon dioxide) and a sedimentation inhibitor, and a pharmaceutical excipient, as desired. The tablet is quickly collapsed by adding water and a suspension is formed. The suspension is stable during a time required for digesting and has an improved taste.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to an effervescent tablet for producing an aqueous suspension of diclofenac or its salts, suitable for oral administration, which tablet contains the active pharmaceutical agent. Provides immediate or long-lasting effects. Furthermore, the present invention is present in micronized form in effervescent tablets and in aqueous suspensions obtainable from suspensions obtainable by disintegrating this dosage form in aqueous water. Furthermore, the present invention relates to diclofenac or a salt thereof having osmotic swelling properties, a method for preparing the effervescent tablet, and uses thereof.

BACKGROUND OF THE INVENTION A variety of drugs with different structures are useful for the treatment of painful inflammatory conditions, such as rhinomatoid arthritis, such as non-steroidal anti-inflammatory drugs (NSAIDs). gets. The poorly water-soluble drug diclofenac belongs to this class of drugs and is also poorly water-soluble and its sodium salt is poorly water-soluble, available under the registered trademark VOLTARBNO (Ciba-Geigy).

Oral dosage forms of N5AIDs, for example tablets that disintegrate in the stomach, present the problem of too slow diffusion as local overconcentrations and, furthermore, insufficient distribution of the active drug within the gastric juices, resulting in long-term disintegration. When administered, there is a risk of irritation to the gastric mucosa and a risk of ulceration. For this reason, NSAIDs in tablet form should be administered with meals, so that distribution, which normally occurs only by diffusion, occurs more quickly and uniformly due to convection of the active drug.

Even when administered outside mealtimes, it can provide a homogeneous distribution of the active ingredient in the gastric fluid irrespective of time and thereby reduce the risk of irritation of the gastric mucosa required by increased concentrations; There is a need to provide new oral dosage forms for N5AIDS. Such dosage forms include: 1. In addition, there is no need to wait for the first dose until food can be taken, and administration immediately when symptoms of pain occur results in a more effective use of diclofenac as an analgesic.

Effervescent formulations containing acetylsalicylic acid as a poorly soluble N5AID with a pronounced analgesic effect are available, for example, from Alka-Seltzer effervescent tablets (Bayer) containing calcium carbonate as a stabilizer. When such effervescent tablets dissolve, a water-soluble calcium salt with a neutral taste is formed. The complete dispersion of this soluble salt in water initiates a rapid analgesic effect in the gastric fluid after ingestion of the solution and, due to the low concentration in a large volume of fluid, reduces the risk of irritation of the gastric mucosa.

To date, no other rapidly disintegrating formulations such as powders or granules into similar effervescent tablets are available for NS8heD diclofenac and its salts.

The reason for this is that if such dosage forms were to disintegrate, the active ingredient could not be converted into a pharmaceutically suitable form of a water-soluble salt with a neutral taste.

Usually, the bitter taste of the active ingredient makes such form or form unsuitable.

[Means for Solving the Problems, Actions and Effects of the Invention] The purpose of the present invention is to provide a new and more therapeutically effective formulation for diclofenac, which is a poorly soluble gastric drug. Disintegrates and improves taste. This formulation provides a homogeneous dispersion of the active ingredient in the aqueous phase without making its taste noticeable upon disintegration.

This object is achieved by the present invention, which relates to a solid, rapidly disintegrating dosage form in the form of an effervescent tablet for producing an aqueous suspension, which is suitable for oral administration and is water permeable. Contains micronized diclofenac or a corresponding coated pharmaceutically acceptable salt of diclofenac with a swellable coating, as well as a pharmaceutically acceptable excipient.

The present invention is suitable for effervescent formulations containing diclofenac, preferably having an average particle size smaller than 200°, further smaller than 100°, a suspending agent and also optionally a pharmaceutical excipient. Concerning sex pills.

When water is added to an effervescent tablet, a suspension is formed;
Accompanied by generation of carbon dioxide gas. This suspension is stable without fixed sediment over the period of about 5 to 10 minutes required for its ingestion, and furthermore has a neutral or pleasant taste. After the dosage form has disintegrated, the diclofenac can be suspended in water and coated with a coating highly permeable to diclofenac, such as a coating of polyvinylpyrrolidone or dimethylaminoethyl methacrylate/methacrylate copolymer of Eudragit type E (R6hm pharma) at a suitable thickness. When given, it is released into the stomach and this coating is stable in the gastric juices.

Rapid release of the active drug is important whenever symptoms of pain should be treated immediately in the short term if it occurs, and a rapid onset of action is desirable at higher doses, while the gastric mucosa The risk of irritation should be virtually eliminated. The selection of non-orally permeable coatings, such as Eudragit E-type acrylate/methacrylate copolymers, and optionally higher thicknesses,
It is possible to prolong the period of action and delay the release of the active ingredient in the stomach. When using diclofenac as an anti-rheumatic drug in long-term treatment, persistence of the active drug is important.

Because, due to their easier and more convenient uptake, aqueous suspensions giving a sustained release of diclofenac for oral administration can advantageously replace conventional tablets with resistant film coatings. . The words and expressions used in the present invention are presented within the scope of the present invention as follows.

The effervescent tablets of the present invention disintegrate in water with the evolution of carbon dioxide within 3 minutes, preferably within 1 minute, and have a slightly cloudy aqueous drinkable, neutral or pleasant taste. Give a suspension of the drug. This suspension can be taken directly after the effervescent tablet has completely disintegrated.

The effervescent tablet contains diclofenac, o-(2°6-dichloroanilino)phenylacetic acid, in free form or as its pharmaceutically acceptable salt.

Particularly preferred salts of diclofenac are the sodium and potassium salts (Metac Index, 10th Edition N
o, 3066).

The micronized diclofenac salt has a preferred average particle size of less than 200 JM, preferably less than 100 μm. Particles with this particle shape can be obtained by grinding in customary grinding means, for example in an air jet mill, a ball mill or a vibrator mill. Micronization is preferably carried out using an ultrasonic disintegrator, such as J. Pharm.

Sci Wolf (9), 1040-1045 (1965
) or by means of a commercially available stirrer, such as a high-speed stirrer, for example a homolex type stirrer (Progri & Company Basel). This is done by stirring.

finely divided diclofenac, or a pharmaceutically acceptable salt thereof, is provided with a permeable, swellable coating;
This coating consists of a material of elastic nature (lO), which is permeable to or to aqueous body fluids, such as gastric fluids or interstitial fluids, and which is also swellable and/or resistant to this body fluid. Soluble.

Water-permeable elastic film-like materials typically include hydrophilic mixtures of polyvinylpyrrolidone or copolymers of polyvinylpyrrolidone and polyvinyl acetate with hydroxymethyl cellulose, mixtures of polyvinylpyrrolidone with polysorbates such as polysorbate 80, shellac, etc. A mixture with hydroxypropylmethylcellulose, polyvinyl acetate or a copolymer thereof with polyvinylpyrrolidone, or a mixture with water-soluble cellulose derivatives such as hydroxypropylmethylcellulose and water-insoluble ethylcellulose. These actual coating agents can be used, if desired, in admixture with other auxiliaries, such as talc or wetting agents such as turbate (eg to facilitate application).

The elastic film-like material is particularly suitable for
Hydrophilic polyvinylpyrrolidone (with an average molecular weight of 0)
pvp-povidone), hydrophilic partially etherified cellulose derivatives and hydrophilic polyacrylates, such as acrylic acid polymers or acrylic acid/methacrylate copolymers.

Examples of hydrophilic partially etherified cellulose derivatives include 1
It is a lower alkyl ether of cellulose having an average molar degree of substitution (MS) greater than and less than 3 and a degree of polymerization of about 100 to 5000.

The degree of substitution is the degree of substitution of hydroxy groups by lower alkoxy groups per glucose unit. The average molar degree of substitution (M S ) is an average value and indicates the number of lower alkoxy groups per glucose unit in the polymer.

The average degree of polymerization (DP) is also an average value and indicates the average number per glucose unit in the cellulose polymer.

Lower alkyl ethers of cellulose are, for example, cellulose derivatives, which are substituted with hydroxymethyl groups (primary hydroxyl groups) of glucose units to form cellulose bases and, if further comprised, with secondary and tertiary groups. 01-C at the second secondary hydroxy group, by the alkyl group,
C substituted preferably by methyl or ethyl or alternatively
3-C4 alkyl group, e.g. 2-hydroxyethinope3
-substituted by hydroxy n-propyl, carboxymethyl or 2-carboxyethyl.

Suitable lower alkyl ethers of cellulose are preferably cellulose derivatives, which are the hydroxymethyl groups (primary hydroxyl groups) of the glucose units and the C8
-C4 alkyl, or alternatively substituted 01-C, alkyl groups, and in the case of a second and further third hydroxy group, substituted by a methyl or ethyl group.

Preferred lower alkyl ethers of cellulose include methyl cellulose (DP: about 200 to 10QQ, MS: about 1.4 to 2.0), ethyl cellulose (DP: about 150
~1000, MS: about 1.2-1.8), e.g. 8 qu
acoat” type (FMC) cellulose, hydroxyethyl cellulose (DP: about 120-1200, M
S:L, 2-1.5), hydroxypropyl cellulose (DP: about 200-3000, MS: about 1.0-3.0
) and hismethylhydroxypropylcellulose (DP: about 200 to 1000, MS: about 1.4 to 2.0), such as Pharmac+jat' type cellulose (Synera).

The hydrophilic polyacrylate is about 1. OXIO3~I
It has an average molecular weight of OX106 and further comprises an acrylic acid polymer or an acrylic acid/methacrylic acid copolymer. The acidic group of acrylic acid and/or methacrylic acid monomer is 0
It is partially or completely esterified with 1-C4 alkyl groups, especially methyl and/or ethyl groups, which ester groups can be substituted by hydrophilic groups, preferably trimethylammoniumethyl.

Preferred polyacrylates are manufactured by Rohm Pharma (We
Iterstadt, registered trademark from the Republic of Germany
It can be done manually under the name +oR80-ti. Particular preference is given to rapidly disintegrating film coatings, such as acrylate/methacrylate copolymers, especially ethyl acrylate/methyl methacrylate copolymers,
Preferably those having an average molecular weight of 800,000, for example EUDRAGIT commercial swellable types based on B[IDR8G to TNB50D, or rapidly disintegrating film coatings of types soluble in gastric fluids such as BLIDRAGIT B It is a matter of form. Types that resist dissolution in gastric juices, such as EIJ [1RAGIT
When using L or S, sustained release can be achieved.

Pharmaceutically acceptable excipients are, for example, viscosity index improvers suitable for stabilizing aqueous suspensions and inhibiting the settling of the coated active drug diclofenac, such as the natural rubber known as gum karaya. macromolecules such as carrageenin or viscarin
(marine colloid) type, guar gum, e.g. Me
Galactomannance of yprogat @ type (Myhal Chemical), especially standard type 30.60.90.12
0, and 150 “Mypro Gate”
gatsO) J, 7 Rubia rubber, alginic acid)
IJum or tragacanth, semi-synthetic polymers such as microcrystalline cellulose of the Avicel O type (FMC), the cellulose ethers mentioned above, such as methylcellulose, ethylcellulose or propylcellulose, with functional groups such as hydroxy or carboxy groups or without functional groups or propylene glycol alginate, polyoxyethylene, e.g. Polyox” (Union Carbide)
, Carbowax' (Gutdrich) or polyglycol (Po1.yglycol).
” ) (Dow Chemical) type, carboxypolymethylene, such as Carbopol (
Gutdrich) type, polyvinyl alcohol (PVA)
), for example polyviol (Polyviol')
(Worker) or MowiolO (Hoechst) type, or polyvinylpyloriton (pvp)
, for example CollidionO (S to B
P) or Plasdone' (GA
F) synthetic polymers selected from the group consisting of types, or colloidal silicates, such as aerosil
o ) (Tegza') or Cabiosil (Cab-o-3
il' ) (Cabot) type colloidal silica.

In addition to the excipients normally used for the preparation of tablets,
Effervescent tablets contain an agent that acts as a source of carbon dioxide as well as an agent that induces the release of carbon dioxide. Agents that act as a source of carbon dioxide include pharmaceutically acceptable mono- and dibasic salts of carboxylic acids, such as alkali metal carbonates or alkali metal bicarbonates, such as sodium or potassium carbonate or sodium bicarbonate, and alkaline earth Metal carbonates, such as calcium or magnesium carbonate, or sodium glycine carbonate. Sodium bicarbonate is preferred as the source of carbon dioxide.

The agents inducing the release of carbon dioxide are preferably pharmaceutically acceptable organic acids and their acid anhydrides or acid salts, which are in solid form and furthermore without premature evolution of carbon dioxide. It can be formulated into granules or tablets containing the coated active drug and other excipients mentioned above.

Pharmaceutically acceptable acids are, for example, organic acids such as tartaric acid, malic acid, fumaric acid, adipic acid, succinic acid, ascorbic acid, maleic acid.

A preferred acid is citric acid.

Pharmaceutically acceptable acid anhydrides are the corresponding anhydrides of the organic acids mentioned above, such as citric anhydride or succinic anhydride.

Examples of pharmaceutically acceptable acidic salts are solid salts of polybasic acids in which at least one acidic function is present, such as sodium hydrogen phosphate or hydrogen phosphate. It is disodium.

For producing effervescent tablets, further surface-active substances or wetting agents (surfactants) can also be used, for example anionic surfactants of the alkyl sulfate type, such as sodium, potassium or magnesium n-dodecyl sulfate. , or nonionic surfactants of the fatty acid/polyhydroxyalcoholate type, such as sorbitan monostearate or sorbitan palmitate or sorbitan tristearate.

Further examples of excipients are powdered fillers, such as evalactose, sucrose, sorbitol, mannitol, starches such as potato starch, rice starch,
Corn starch, wheat starch or amylopectin, or cellulose, preferably microcrystalline cellulose.

Furthermore, the ingredients can improve the appearance and taste of aqueous suspensions obtainable by disintegration of effervescent tablets. Examples of such ingredients are colorants, sugars or sweeteners.

The use of colorants is useful for enhancing the appearance of the composition as well as for purposes of its disintegration. Colorants approved for use in pharmacies are, for example, carotenoids, iron oxides or chlorophyll.

Examples of sugars and sweeteners are sucrose, xylitol, D-
xylose, D-glyose, sorbitol, mannitol or lactose, as well as sodium saccharin, dultin, ammonium lysinate or sodium cyclamate.

Effervescent tablets are prepared by micronizing solid particles of diclofenac, imparting a permeable and swellable coating to the micronized particles, and tabletting the coated composition. Pharmaceutical excipients may be added if desired.

Coating of the micronized diclofenac with the above-mentioned coating agents can be carried out using conventional techniques for coating finely divided materials, such as in water or organic solvents or mixtures thereof, such as ethanol, isopropanol, acetone or methylene chloride in the desired proportions. This can be carried out by suspending or dissolving the coating agent and then adding the desired additives.

This preferred 4-6% solution or suspension is applied to diclofenac powder or a mixture thereof with other excipients in a known manner, e.g. in a fluidized bed, e.g. Resprayed by spray coating using the Worcester air suspension technique using a gel coke system.

Flowable granules that can be mixed with agents capable of releasing carbon dioxide, such as sodium bicarbonate, as well as corresponding agents that induce the release of carbon dioxide, such as citric acid, are used to slowly and completely remove the solvent and then It can be obtained by sieving the residue to a preferred average particle size of about 50 to 200'.

The coated active drug granules are mixed in the manner described above with the acids described above and fillers necessary for the preparation of effervescent tablets, such as lactose and cellulose, and lubricants such as polyethylene glycol, and the mixture is formed into effervescent tablets. Pressure is applied. Due to the high content of excipients, a tablet machine is used which is suitable for producing large tablets with a diameter of 3.5 cm and a thickness of up to about 1 cm. Tableting is carried out under moisture-free conditions or in an inert gas atmosphere. Tablets may be individually packed in foil.

The present invention preferably comprises diclofenac having an average particle size of less than 200 squares and with a permeable, swellable coating preferably having a thickness of less than 100 squares, excipients suitable for effervescent formulations, anti-settling agents. The present invention relates to an effervescent tablet containing an agent and optionally a pharmaceutical excipient.

The invention is further illustrated in a non-limiting manner by the following examples.

〔Example〕

Example 1 Effervescent tablet of diclofenac (50mg) diclofenac 50mg galactomannan myprogut 32mg (Me
yprc+3at0150) Colloidal Silica Aerosil 1mg
(Aeros'i 1@20'O) EudragitO, NB 3
0 D, solid 7mg polyethylene glycol 80
00 50mg Sodium Bicarbonate
825mg citric acid, acid anhydride
1160mg Microcrystalline Cellulose 200mg Avicel (Av
+celOpH102) 400mg diclofenac, Meyprogat
) 150 first part and x7o Jill (Aeros
Eudragit (εu
dragit') NE in a fluidized bed and then dried. The coated active drug was mixed with polyethylene glycol 8000, sodium bicarbonate, citric acid, and MeyprogatO.
) 150 and an outer phase consisting of microcrystalline cellulose and the homogeneous mixture is then compressed in a conventional tablet machine to obtain effervescent tablets (diameter: 19 mm, thickness: 6++++++).

Example 2 Effervescent tablet of diclofenac <50mg) diclofenac 53mg galactomannan myprogut 33mg (M
eyprogato150) Eudragit' NE 30
D, Solid 7mg ground lactose
400mg polyvinylpyrrolidone (P
VP' K 30) 10mg Polyethylene Glycol 8000 50mg Sodium Bicarbonate 700mg
Citric acid, anhydride 975m
g Microcrystalline cellulose 10
0mg7se'se) Shikuhev+celOp old 02)24(
lQmg Diclofenac and Myprogut (Meypro-
gat') NE 3 in a fluidized bed.
Spray with an aqueous suspension of 0 [1 and dry. The coated active drug is mixed with milled lactose and PVP@30 and the mixture is granulated with water. Dry Negoo granules were mixed with polyethylene glycol 8000, sodium carbonate, citric acid, Meypr
o-roatO>150 and the external phase from microcrystalline cellulose and then compress the mixture into effervescent tablets.

Example 3 Effervescent tablets of cyclofenac (50 mg) Cyclofenac 50 mg EudraBit' NE 30 D, solid ? +++g ground lactose
400mg Polyvinylpyrrolid 7 (PVP
'K 30) 10mg polyethylene glycol 8000 50mg sodium bicarbonate 700mg citric acid, anhydride 950m
g Diclofenac and Myprogut (Meypro)
-gatO) 150 in a fluidized bed.
Sprinkle with an aqueous suspension of Budragit'N[E 30 D and dry. The coated active drug is mixed with ground lactose and IIVPOK 30 and the mixture is granulated with water. The dried kneader granules (to 2) are mixed with an outer phase consisting of polyethylene glycol 8000, sodium bicarbonate, citric acid, and microcrystalline cellulose and the mixture is compressed into effervescent tablets.

Example 4 Effervescent tablet of diclofenac (50mg) Diclofenac 50mg Colloidal Silica Aerosil 1mg (8er
osilo 200) Budragite NB 30
D, solid 7mg polyethylene glycol 800
0 50mg sodium bicarbonate
855mg citric acid, anhydrous
1205mg microcrystalline cellulose 200mg aze'cell (8v
icel' pH102) 240On+g Diclofenac, Meyprogat
t') 150 and Aerosil'
200 of Eudragit (Eu) in a fluidized bed.
spray with an aqueous suspension of NE 30 and dry. The coated active drug is mixed with an outer phase consisting of polyethylene glycol 8000, sodium bicarbonate, citric acid and microcrystalline cellulose and the homogeneous mixture is compressed into effervescent tablets in a tablet machine.

Example 5 Effervescent tablet of diclofenac (50mg) diclofenac 50mg galactomannan myprogut 32mg (Me
yprogat0150) Colloidal Silica Aerosil 1mg
(Aerosil' 200) Eudragit NB 30
D, solid 25mg polyethylene glycol 800
0 50mg sodium bicarbonate
825mg citric acid, anhydride
1142mg Galactomannan Mypro Gatsuto 75mg (Meypro
gat' 150) Microcrystalline cellulose 200m
g Acecel (^v+cel@pold 02) 400 mg Preparation of effervescent tablets was the same as in Example 1.

Example 6: Diclofenac effervescent tablet (50mg > diclofenac 50mg galactomannan myprogut 33mg (Me
yprogat0150) Colloidal Silica Aerosil 1mg
(Aerosil' 200) Aquacoat' BOC, solid
25mg polyethylene glycol 8000
50mg sodium bicarbonate
825mg citric acid, anhydride
1142mg Microcrystalline Cellulose 200mg Azese/l/ (A
vicel' pH102) 400mg diclofenac, Myprogut (Meypro-
gat") 150 and Aerosil (8erosil
'>200 mixture was treated with Aquacoat (Aq
Sprinkle with an aqueous suspension of BCD30 (uacoat') and dry. The coated active drug is mixed with an outer phase consisting of polyethylene glycol 8000, sodium bicarbonate, citric acid and microcrystalline cellulose, and the homogeneous mixture is then compressed in a tablet machine to obtain effervescent tablets.

Example 7: Diclofenac effervescent tablet (50 mg) Diclofenac 50 mg Galactomannan Myprogut 36.7m
g (Meyprogat@150) Colloidal Silica Aerosil 1.1
mg (Aerosil' 200) Cell o-ce HPM-6037yl "J-to"
5.5mg (Pharmacoat@) Polyethylene Glycol 8000 5
0 mg sodium bicarbonate
850 ■Citric acid, anhydride
A mixture of 1206.7 mg diclofenac, Meypro-gat' 150 and Aerosil" 200 is sparged with an aqueous suspension of Pharmacoat@ in a fluidized bed and dried. Coat 29) The active drug is mixed with an outer phase consisting of polyethylene glycol 8000, sodium bicarbonate, citric acid and microcrystalline cellulose and the homogeneous mixture is compressed in a tablet machine to obtain effervescent tablets.

Example 8 Effervescent tablet of diclofenac (50mg) diclofenac 50mg galactomannan myprogut 35+ng (M
eyprogat” 150) Colloidal Silica Aerosil 1mg
(Aerosil' 200) Eudragit (Budragit') NB 30
D 50mg polyethylene glycol 8
000 50mg Sodium Bicarbonate
830 mg citric acid, anhydride 1184 mg By-products are prepared as in Example 4.

Method for measuring disintegration rate - US Puzzle, 5Qrpm Medium - 60 minutes, 0.1N HCL, pH 1,0-60
minutes, phosphate buffer, pH 6,8 Results Percentage of diclofenac (%) After 60 minutes 4 After 120 minutes 50 After 240 minutes 77 After 420 minutes 93 Example 9 Effervescent tablets of diclofenac (50 mg) Diclofenac 46.5 mg Colloidal Silica Aerosil 1 mg (A
erosi10200) 30 10m to polyvinylpyrrolidone
g Polysorbate 80 0.
8mg polyethylene glycol 8000 powder
60 mg sodium bicarbonate
700 mg citric acid, anhydrous
1344.7mg mybitol
200mg400mg diclofenac, Meypro-g
at') 150 and Aerosil (8erosilO)
) 200 (7) mixture is sparged with an aqueous suspension of polyvinylpyrrolidone K 30 and polysorbate) 80 in a fluidized bed and dried. The coated active drug is mixed with an outer phase consisting of polyethylene glycol 8000, sodium bicarbonate, citric acid and marbitol, and the homogeneous mixture is then compressed in a tablet machine to obtain effervescent tablets.

Claims (1)

Claims: 1. A solid, rapidly disintegrating dosage form in the form of an effervescent tablet for producing an aqueous suspension for oral administration, the dosage form comprising a water permeable swelling. Said dosage form comprising finely divided diclofenac with a sex coating or a correspondingly coated pharmaceutically acceptable salt of diclofenac and a pharmaceutically acceptable excipient. 2, having an average particle size smaller than 200 μm, and
Micronized diclofenac with a coating of polyvinylpyrrolidone, lower alkyl ethers of cellulose or permeable, swellable acrylate/methacrylate copolymers, excipients suitable for solid effervescent formulations, suspending agents and optionally pharmaceutical additives. An effervescent tablet according to claim 1, containing excipients. 3. Effervescent formulation according to claim 2, containing micronized diclofenac having an average particle size smaller than 100 μm. 4. Micronized diclofenac with a coating of osmotic ethyl cellulose or methyl hydroxypropyl cellulose or osmotic swellable ethyl acrylate/methyl methacrylate copolymer, excipients suitable for solid foam formulations, suspending agents and optionally The effervescent preparation according to claim 2 or 3, which contains an excipient. 5. Finely micronized diclofenac with a coating of an osmotic, swellable acrylate/methyl methacrylate copolymer having an average particle size of less than 200 μm and an average molecular weight of about 800,000, a pharmaceutically acceptable carbonate salt, and The foaming preparation according to claim 4, which contains an organic acid, a cold water-soluble hydrocolloid as a suspending agent, and optionally an excipient. 6. An aqueous suspension of diclofenac suitable for oral administration, obtainable by disintegrating a solid, rapidly disintegrating dosage form according to claim 1 in aqueous water. 7. Micronized diclofenac coated with an osmotic, swellable ethyl acrylate/methyl methacrylate copolymer or polyvinylpyrrolidone. 8. A method for preparing a solid rapidly disintegrating dosage form according to claim 1, comprising micronizing solid particles of diclofenac and applying an osmotic, swellable coating to the micronized diclofenac. said method comprising applying and then formulating the coated active drug with a pharmaceutical excipient. 9. Use of the solid rapidly disintegrating dosage form according to claim 1 to obtain an aqueous suspension of diclofenac for oral administration. 10. A solid, rapidly disintegrating dosage form according to claim 1 for use in a method of human or veterinary treatment. 11. A solid, rapidly disintegrating dosage form according to claim 1 for use in the treatment of pain in humans or animals.