Solid self-emulsifying dosage form

Abstract

A solid self-emulsifying dosage form comprises a self-emulsifying composition which is loaded onto crosslinked poly(vinyl pyrrolidone). The liquid self-emulsifying composition is converted into a powder which reveals good stability and can be easily processed and transformed into convenient dosage forms like capsules or tablets. The solid self-emulsifying dosage form has adequate drug release properties.

Description

[0001] Solid self-emulsifying dosage form

[0002] The present invention relates to a solid self-emulsifying dosage form comprising a self-emulsifying drug delivery system (SEDDS) which is loaded onto crosslinked poly(vinyl pyrrolidone).

[0003] It is an important aspect in administration of beneficial ingredients, e.g., in the administration of a pharmaceutically active ingredient, to ensure adequate absorption of the active ingredient in the gastrointestinal tract and plasma levels high enough to be therapeutically active. This is a non-trivial task, especially in cases where the beneficial ingredient has a low solubility in water. It is commonly recognized in the pharmaceutical industry that on average more than 40% of newly discovered drug candidates are poorly water-soluble. In such cases, the lipophilic beneficial ingredient may be incorporated into a lipid-based self-emulsifying composition. It is desirable to convert the liquid lipid-based systems into powders which reveal good stability and can be easily processed and transformed into convenient dosage forms like capsules or tablets. To this end, it has been suggested to adsorb the self-emulsifying composition on solid carriers, e.g., solid inorganic carriers.

[0004] Such lipid-based self-emulsifying composition are known in the state of the art. For example, US 2017 / 119674 Al describes a composition comprising a lipophilic compound having a log P of at least 5, and a self-emulsifying vehicle. The selfemulsifying vehicle comprises (a) a fat component and (b) a hydrophilic surfactant. The self-emulsifying vehicle is adsorbed into a solid core comprising silicon dioxide.

[0005] Release studies showed that active ingredients adsorbed to silicas are incompletely released from the silica surface in dissolution media, with a quantity of active ingredient remaining on the silica surface after dissolution. These results suggest that a fraction of loaded drug molecules was tightly bound to the silica surface or attached to sites which are inaccessible for the dissolution media. Factors contributing to incomplete drug release from silica formulations are not well understood.

[0006] US 5,449,521 discloses amorphous drug absorbed onto a support material. The support material may be crosslinked polymers, linear polymers, water-soluble complexing agents, and porous inorganic materials. The drug and support material are co-ground in a mill with its grinding chamber saturated with the vapor of one or more solvents able to solubilize the drug.

[0007] It is therefore an object of the present invention to provide a solid self-emulsifying dosage form with adequate drug release properties, and a method of its manufacture.

[0008] This object is solved by the solid self-emulsifying dosage form of the invention which comprises a self-emulsifying composition which is loaded onto crosslinked poly (vi nyl pyrrolidone).

[0009] Herein, the term “crosslinked poly (vi nyl pyrrolidone)” may suitably be abbreviated as “crosslinked PVP”, or "cPVP”.

[0010] The invention further relates to a method for preparing a solid self-emulsifying dosage form, the method comprising

[0011] - emulsifying the self-emulsifying composition in water to obtain an emulsion,

[0012] - loading the emulsion onto crosslinked poly(vinyl pyrrolidone) to obtain a wet powder of loaded crosslinked poly(vinyl pyrrolidone), and

[0013] - drying the wet powder.

[0014] The present invention involves a self-emulsifying dosage form comprising a selfemulsifying composition. Self-emulsifying and self-micro emulsifying compositions are those which spontaneously form emulsions or micro emulsions on contact of the contents of the solid oral dosage form with the gastric or intestinal fluids and which are commonly termed self-emulsifying drug delivery systems (SEDDS) or self-micro emulsifying drug delivery systems (SMEDDS).

[0015] SEDDS produce opaque, white emulsions with lipid droplet sizes of 200 nm or higher, while SMEDDS form transparent or translucent microemulsions with droplet size of less than 200 nm.

[0016] The crosslinked poly(vinyl pyrrolidone), also known as crospovidone, is commercially available.

[0017] The crosslinked poly(vinyl pyrrolidone) is generally in the form a finely-divided solid, i.e., a powder. Suitably, the crosslinked poly (vi nyl pyrrolidone) has a particle size distribution (PSD), wherein at least 90% of the particles have a particle size of more than 100 pm, and at least 70% of the particles have a particle size of more than 50 pm. PSD is suitably determined using an air jet sieve after 5 min at 20 mbar.

[0018] Suitably, the crosslinked poly(vinyl pyrrolidone) has a water adsorption in the range of from 3.0 to 8.5 g water / g cPVP, preferably 7.0 to 8.5 g water / g cPVP. Water adsorption may be determined as follows: Weigh 2.0 g of cPVP into a 100 mL centrifuge tube, add 40 mL of water and shake vigorously until the powder is suspended. Re-suspend after 5 min and again after 10 min. Then centrifuge for 15 min at 2000 rpm. Decant the supernatant liquid, then weigh again. The water adsorption is calculated as the quotient of the weight after hydration and the initial weight.

[0019] Generally, the self-emulsifying composition comprises a beneficial ingredient, and a self-emulsifying vehicle. With the term “beneficial ingredient” is meant an ingredient that exerts a beneficial effect, e.g., a therapeutically beneficial effect, when administered to a subject, e.g., to a human or other mammals. “Beneficial ingredient” as used herein, refers to any compound, mixture of compounds, or composition of matter consisting of a compound, which produces a beneficial or useful result. Any suitable beneficial ingredient can be used. Suitable beneficial ingredients can include, for example, pharmaceutically active ingredients, nutraceutical active ingredients, breath fresheners (e.g., mints, such as peppermint, spearmint, etc.), confectionary products (e.g., candy, flavored products, etc.), and the like, and combinations thereof.

[0020] In an embodiment, the beneficial ingredient is a pharmaceutically active ingredient. For example, such pharmaceutically active ingredients may include medicaments or drugs such as analgesics, anti-inflammatory ingredients, anthelmintics, anti- arrhythmic ingredients, antibiotics, anticoagulants, antidepressants, antidiabetic ingredients, antidiarrheal ingredients, antiemetic ingredients, antiepileptics, antihistamines, antihypertensive ingredients, antimuscarinic ingredients, antimycobacterial ingredients, antineoplastic ingredients, immunosuppressants, antithyroid ingredients, anti-tussive ingredients, antiviral ingredients, anxiolytic sedatives, astringents, beta-adrenoceptor blocking ingredients, cardiac inotropic ingredients, corticosteroids, cough suppressants, diagnostic ingredients, diagnostic imaging ingredients, diuretics, dopaminergics, haemostatics, immuriological ingredients, lipid regulating ingredients, muscle relaxants, parasympathomimetics, parathyroid calcitonin and biphosphonates, prostaglandins, radio-pharmaceuticals, steroids, anti-allergic ingredients, stimulants and anoretics, sympathomimetics, thyroid ingredients, vasodilators, xanthines, and the like, and combinations thereof.

[0021] Exemplary pharmaceutically active ingredients include, e.g., mirtazapine, olanzapine, ondansetron, NSAIDs, acetaminophen, enalapril, famotidine, fluoxetine, lorazepam, loperamide, loratidine, narcotic analgesics, e.g., morphine, hydrocodone, and the like, oxazepam, piroxicam, rizatriptan, zolmitriptan, zolpidem, hyoscyamine and salts thereof, e.g., hyoscyamine sulfate, and the like.

[0022] Nutraceutical active ingredients can include, for example, dietary supplements, vitamins, nutraceutical oils such as omega-3 oil and the like, and combinations thereof.

[0023] Exemplary nutraceutical active ingredients include, e.g., vitamin A, vitamin D, vitamin E (e.g., d- a -tocopherol, d- a -tocopheryl acetate, dl- a -tocopherol and dl- ct - tocopheryl acetate), vitamin Bl and derivatives thereof, vitamin B2 and derivatives thereof, vitamin B6 and derivatives thereof (e.g., pyridoxine hydrochloride), vitamin C and derivatives thereof (e.g., ascorbic acid, sodium L-ascorbate, etc.), vitamin B12 and derivatives thereof, fluoride (e.g., sodium fluoride), calcium, magnesium, iron, proteins, amino acids, oligosaccharides, and the like, and combinations thereof.

[0024] It will be appreciated that there may be circumstances in which a pharmaceutically active ingredient also may function as a nutraceutical active ingredient, and in which a nutraceutical active ingredient also may function as a pharmaceutically active ingredient.

[0025] Beneficial ingredients also can include, for example, detergents, foaming ingredients, anti-foaming ingredients, agriculturally beneficial products (e.g., fertilizers, pesticides, antimicrobial ingredients, herbicides, etc.), and the like, and combinations thereof. It will be appreciated that the beneficial ingredient also can include one or more of the additional ingredients in the tablet of the present invention, e.g., the directly compressible, water-soluble carbohydrate, the directly compressible, water insoluble filler, and the like. In an embodiment, the beneficial ingredient is poorly water-soluble. Solubility is one of the important parameters to achieve a desired concentration of a beneficial agent in solution for a pharmacological response to be elicited. Solubility plays an essential role in drug disposition, since it is only that drug in solution that is able to diffuse through a biological matrix or passively transport across a biological membrane. The maximum rate for drug absorption is a product of permeability and solubility. Drug efficacy can be severely limited by poor aqueous solubility. Poor solubility properties of drugs leads to ineffective absorption from the site of administration.

[0026] It is evident from the above that it is practically impossible to formulate poorly water- soluble beneficial agents with an aqueous medium, e.g., for oral administration. Generally, poor solubility in water is associated with a high lipophilicity. Thus, the lipophilic beneficial agents are suitably incorporated into a lipid phase, e.g., in a lipid of the self-emulsifying vehicle of the self-emulsifying composition as described above.

[0027] The present invention allows for enhancing intestinal absorption of poorly water- soluble beneficial ingredients. The invention may specifically be applicable to beneficial ingredients conforming to Class lib or IV, according to the Developability Classification System, DCS.

[0028] The self-emulsifying vehicle may comprise at least one lipid and at least one surfactant. Suitably, the weight ratio of the at least one lipid to at least one surfactant is in the range of from 1:7 to 7:1, preferably 1:4 to 4:1.

[0029] Preferred lipids are those which an organism can assimilate and, where appropriate, metabolize. Natural lipids and derivatives of natural lipids, which may be of vegetable or animal origin, are preferred. Derivatives of natural lipids include in particular those natural lipids which have been chemically and / or physically treated. A suitable chemical treatment is, for example, hydrogenation of unsaturated fatty acids or fatty acid residues in glycerides. A suitable physical treatment is, for example, fractionation of natural lipid mixtures.

[0030] Suitably, the lipid may be selected from mono-glycerides, di-glycerides, tri-glycerides of C14-C24fatty acids, or mixtures thereof. The fatty acid may be saturated, monounsaturated or polyunsaturated fatty acids or derivatives thereof. Each chain in the fatty acid or glyceride may have, for example, 0, 1, 2, or 3 double bonds. Preferably, the lipid comprises a mono-glyceride and a tri-glyceride, wherein the weight ratio of tri-glycerides to mono-glycerides is in the range from 1:2 to 6:1.

[0031] In an embodiment, the lipid is present in an amount of from 20 to 70 wt.-%, based on the weight of the self-emulsifying composition.

[0032] In a preferred embodiment, the fatty acids are selected from linolenic acid, oleic acid, palmitic acid, linoleic acid, and stearic acid.

[0033] In an embodiment, the lipid comprising a tri-glyceride of fatty acids is selected from a naturally derived oil. For example, the naturally derived oil is selected from soybean oil, olive oil, sesame oil, safflower oil, peanut oil, rapeseed oil, sunflower oil, coconut oil, corn oil, sunflower seed oil, cotton seed oil, palm oil, and arachis oil, and combinations thereof.

[0034] Preferably, the lipid is selected from soybean oil, corn oil, glycerol monooleate, glyceryl mono-caprylocaprate, winterized oil composed of long-chain mono-, di-, and tri-glycerides, medium chain tri-glyceride based lipids, and mixtures thereof.

[0035] The surfactant may be selected from a hydrophilic surfactant with a hydrophilic- lipophilic balance (HLB) value of 13 or higher. The HLB system (hydrophilic lipophilic balance system) assigns numerical values to surface-active substances; the HLB values of lipophilic substances are low, and those of hydrophilic ones are higher (Fiedler, H. B., Lexikon der Hilfsstoffe fur Pharmazie, Kosmetik, and angrenzende Gebiete, 4th edition, Aulendorf: ECV-Editio-Cantor-Verlag (1996)).

[0036] Examples of suitable surfactants are selected from

[0037] - esters of mono- or di-glycerides such as the acetic, succinic, lactic, citric or tartaric esters

[0038] - propylene glycol mono- or di-esters of fatty acids

[0039] - polyglycerol esters of fatty acids

[0040] - ethoxylates of fatty acids

[0041] - ethoxylates of fatty acid esters

[0042] - sorbitan esters of fatty acids

[0043] - transesterification products of natural or hydrogenated vegetable oil tri-glycerides and polyalkylene polyol - alcohol ethoxylates

[0044] - polyoxyethylene or polyoxypropylene copolymers

[0045] - phospholipids

[0046] - polyoxyethylene sorbitan fatty acid derivatives (such as polysorbates, e.g., polysorbate 80)

[0047] - castor oil or hydrogenated castor oil ethoxylates, for example Polyoxyl 35 castor oil / Cremophor EL™

[0048] - anionic surfactants, such as sodium lauryl sulfate or sodium oleate

[0049] - alkylphenol surfactants

[0050] - and combinations thereof.

[0051] Preferably, the surfactant is selected from castor oil or hydrogenated castor oil ethoxylates, polyoxyethylene or polyoxypropylene copolymers, and mixtures thereof.

[0052] The self-emulsifying vehicle may comprise at least one additional co-solvent. The co-solvent may be selected from lower alcohols, such as ethanol, and mixtures of ethanol with water. Addition of an additional co-solvent may facilitate the dissolution of the beneficial agent in the self-emulsifying vehicle.

[0053] In an embodiment, the dosage form is a capsule filled with the crosslinked poly (vi nyl pyrrolidone) loaded with the self-emulsifying composition. For brevity, the term “crosslinked poly(vinyl pyrrolidone) loaded with the self-emulsifying composition” is used synonymously with the term “emulsion-loaded cPVP”.

[0054] Encapsulation in (hard) capsules, i.e., the production of unit dosage forms containing beneficial agents, is known in the art. For example, such capsules may be hard gelatin capsules or hard hydroxypropyl methylcellulose (HPMC) capsules. Hard capsules are generally formed from two distinct parts, namely the “cap” and the “body”, fitting one into the other so as to form the complete capsule. The cap and the body are manufactured by the same process consisting of immersing in a solution, e.g., a gelatin or HPMC solution, the end of a mandrel whose form corresponds to the inner volume of the cap or of the body, then withdrawing the mandrel from the solution and letting the layer, e.g. the layer of gelatin or HPMC, thus deposited dry, which is then removed like a glove finger. For the purpose herein, conventionally known encapsulation machines may be used to fill the emulsion- loaded cPVP into the so obtained capsule cap and / or the so obtained capsule body and to subsequently connect the cap and body. As a result, a capsule filled with the emulsion-loaded cPVP, i.e., the solid self-emulsifying dosage form of the present invention is obtained.

[0055] In an embodiment, the dosage form is a tableted dosage form obtained by tableting the crosslinked poly(vinyl pyrrolidone) loaded with the self-emulsifying composition with a matrix building component, and, optionally, a tableting aid.

[0056] The term “matrix building component” embraces substances used for binding particles and at the same time for controlling the delivery of active principles, such as cellulose derivatives, synthetic and semisynthetic polymers, sugars as glucose and saccharose, polysaccarides and proteins. Particularly preferred are hydroxypropyl methylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, microcrystalline cellulose, carboxymethylcellulose, methylcellulose, cellulose acetate, cellulose acetate propionate, ethylcellulose poliox, granular calcium phosphate, sucrose, glucose, lactose, scleroglucan, alginates, chitosan, cyclodextrins, pectins, arabic gum, guar gum, carrageenan, xanthan gum, acacia, starch, dextrins, gelatin, collagen, albumin, poly(vinyl pyrrolidone), polymethacrylates, carbomer, poloxamer, polyethylene glycol, poly(vinyl alcohol), poly(ethylene oxide). As regards control of delivery, it is intended that the nature of the matrix building components is such that the dosage forms obtained therefrom are destroyed quickly or slowly upon exposure to water solution. According to the intended use, i.e., the provision of a dosage form, the matrix building components can thus be adequately chosen by the skilled person to allow for destruction of the dosage forms upon interaction with aqueous fluids within a pre-envisaged time interval.

[0057] The term “tableting aids” encompasses ingredients used in addition to the matrix building component and the crosslinked poly (vi nyl pyrrolidone) loaded with the selfemulsifying composition for providing a mixture suitable for use in tableting, such as matrix building components, lubricants, glidants and / or anti-adherent agents.

[0058] Tableting aids as mentioned above refer to those pharmaceutically acceptable additives which are commonly employed to allow the filling of the powdery mixture into the tableting press and the extraction of the compacted body from the dies. They are widely known in the art and employed to increase the flowability of the powder and to reduce surface adhesion between the compacted body and the punches. Prominent, but not exclusive examples include calcium stearate, glyceryl monostearate, glyceryl palmitostearate, hydrogenate castor oil, hydrogenate vegetable oil, light mineral oil, magnesium stearate, colloidal silica, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, stearic acid, talc, and zinc stearate.

[0059] The step of tableting the crosslinked poly(vinyl pyrrolidone) loaded with the selfemulsifying composition with the tableting aid to obtain the tableted dosage form is carried out in a conventional way known to the skilled person. For example, the crosslinked poly(vinyl pyrrolidone) loaded with the self-emulsifying composition is mixed with the matrix building component and the tableting aid in order to obtain a powdery composition. Said powdery composition is then compressed within a tableting machine or molding press using punches as conventionally used in pharmaceutical industry. Suitably, the punches may have a diameter in the range of from 2 to 25 mm, and compression forces in the range of from 2 to 50 kN may be applied. Finally, the obtained resulting tableted dosage form, i.e., the solid selfemulsifying dosage form, is then recovered from the tableting machine or molding press.

[0060] The invention further relates to a method for preparing a solid self-emulsifying dosage form, the method comprising

[0061] - emulsifying the self-emulsifying composition in water to obtain an emulsion,

[0062] - loading the emulsion onto crosslinked poly(vinyl pyrrolidone) to obtain a wet powder of loaded crosslinked poly(vinyl pyrrolidone), and

[0063] - drying the wet powder.

[0064] It has been found that the self-emulsifying composition as such does not readily adsorb onto the crosslinked poly(vinyl pyrrolidone). Surprisingly, the method of the invention allows for overcoming the disadvantage that (lipid-based) self-emulsifying compositions cannot easily be adsorbed on the surface of carriers such as cPVP. The step of emulsifying the self-emulsifying composition in water yields an emulsion which may readily be adsorbed on crosslinked poly(vinyl pyrrolidone).

[0065] For this purpose, the self-emulsifying composition is emulsified with a suitable amount of water. The weight ratio of the self-emulsifying composition and water may be in the range of from 3:1 to 1:2. To prepare the emulsion, the self-emulsifying composition may be mixed with water and stirred. After contacting the resulting emulsion with the crosslinked poly(vinyl pyrrolidone), the emulsion is adsorbed onto the external and internal surface(s) of the crosslinked poly(vinyl pyrrolidone). As a result, a wet powder of loaded crosslinked poly(vinyl pyrrolidone) is obtained.

[0066] Suitably, said wet powder is subsequently dried to obtain a dried powder. In other words, water originating from the step of emulsifying as described above, and, if present, additional co-solvents originating from the self-emulsifying composition, may be removed from the wet powder in the drying step.

[0067] Suitably, for drying the wet powder, a fluidized bed dryer, a tray dryer or a vacuum dryer may be used. Fluidized bed dryers are used for reducing the moisture content of a powder. For this purpose, the wet powder is fluidized, for example in a metal tube, and hot supply air is introduced at high pressures through a perforated bed plate. As a result, the wet powder is lifted from the bed plate and suspended in a stream of air (fluidized state). Heat transfer is accomplished by direct contact between the wet powder and the hot supply air. The vaporized liquid, i.e., water and, if present, ethanol, is carried away by exhaust gases exiting the metal tube via the opening at the opposite side to the bed plate.

[0068] The dried powder reveals good stability and can be easily processed and transformed into convenient dosage forms like capsules or tablets.

[0069] In an embodiment, the method comprises filling the dried powder into a capsule to obtain the solid self-emulsifying dosage form. As described above, the dried powder may be filled into a preformed capsule cap and body, and the so obtained filled cap and body is then suitably connected to obtain the solid self-emulsifying dosage form of the present invention. For this purpose, a conventionally known encapsulation machine may be used.

[0070] In an embodiment, the method comprises tableting the dried powder with the matrix building component, and, optionally, the tableting aid to obtain the solid selfemulsifying dosage form. Tableting of the dried powder with the matrix building component, and, optionally, the tableting aid is described in detail above. Examples

[0071] The invention is further illustrated by the examples that follow. Preparation of self-emulsifying vehicles

[0072] Self-emulsifying vehicles 1 to 3 were prepared as shown in tables 1 to 3 that follow.

[0073] The ingredients were molten where appropriate, mixed and homogenized. Table 1: Self-emulsifying vehicle 1.

[0074] [1] Medium chain tri-glyceride based lipids

[0075] [2] Winterized oil composed of long-chain mono-, di-, and tri-glycerides

[0076] [3] Polyoxyl 40 hydrogenated castor oil Table 2: Self-emulsifying vehicle 2.

[0077] [1] Medium chain tri-glyceride based lipids

[0078] [2] Polyoxyl 40 hydrogenated castor oil

[0079] Table 3: Self-emulsifying vehicle 3.

[0080] [1] Medium chain tri-glyceride based lipids

[0081] [2] Poloxamer 124

[0082] Preparation of emulsions

[0083] The resulting self-emulsifying vehicles 1 to 3 were mixed with menthol as beneficial ingredient and water to obtain emulsions 1 to 9 as shown in table 4. Mixing was carried out using an overhead stirrer or magnetic stirrer.

[0084] Table 4: Emulsions 1 to 9.

[0085] [1] See table 1

[0086] [2] See table 2

[0087] [3] See table 3

[0088] [4] Beneficial ingredient

[0089] Preparation of emulsion-loaded cPVPs

[0090] The resulting emulsions 1 to 9 were loaded onto the crosslinked poly(vinyl pyrrolidones) (PVP) as shown in table 5. Loading was carried out using a high shear Diosna Pl / 6 mixer having a 1 L container at a chopper speed of 2000 rpm and a stirrer speed of 400 rpm.

[0091] Table 5: Emulsion-loaded cPVPs 1 to 9.

[0092] [1] See table 4

[0093] [2] crosslinked PVP

[0094] [3] Polymer consisting of 75% polyvinyl alcohol units and 25% polyethylene glycol units

[0095] [4] Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer

[0096] The resulting emulsion-loaded cPVPs 1 to 9 were wet-sieved via a 1000 pm sieve to obtain a wet powder and their menthol content was determined. For this purpose, the wet powder was suspended in water, stirred and filtered to obtain a clear filtrate. The menthol content was determined from the resulting clear filtrate by photometric determination (UV). For all emulsion-loaded cPVPs 1 to 9, > 98 wt.-% of the used menthol was recovered.

[0097] Tableting

[0098] Emulsion-loaded cPVP 1 (table 5, entry 1) was used in tableting experiments. For this purpose, a pre-determined amount of emulsion-loaded cPVP 1 was dried, wherein the water and the co-solvent ethanol were removed. Subsequently, the dried emulsion-loaded cPVP 1 was mixed with a suitable excipient as exemplarily shown in table 6 and mixed in a turbula mixer (available from WAB) for 10 min. Then, tablets having a weight of approximately 350 mg were pressed using a STYL’On tablet press (available from Korsch Tablet Presses) with a 10 mm punch at 6.3 kN, 14.3 kN and 23.6 kN.

[0099] Table 6: Tableting mixes. [1] See table 5, entry 1

[0100] [2] Coprocessed excipient based on lactose monohydrate (87%), crospovidone (9%), Kollicoat® IR (3%) and sodium stearyl fumarate (1%)

[0101] Stable tablets with sufficient thickness, diameter, hardness and tensile strength were obtained.

Claims

Claims1. A solid self-emulsifying dosage form, comprising a self-emulsifying composition which is loaded onto crosslinked poly(vinyl pyrrolidone).

2. The dosage form according to claim 1, wherein the self-emulsifying composition comprises a beneficial ingredient, and a self-emulsifying vehicle.

3. The dosage form according to claim 2, wherein the beneficial ingredient is a pharmaceutically active ingredient.

4. The dosage form according to any one of the preceding claims, wherein the self-emulsifying vehicle comprises at least one lipid and at least one surfactant.

5. The dosage form according to claim 4, wherein the lipid is selected from monoglycerides, di-glycerides, tri-glycerides of C14-C24fatty acids, or mixtures thereof.

6. The dosage form according to claim 4 or 5, wherein the lipid is selected from soybean oil, corn oil, glycerol monooleate, glyceryl mono-caprylocaprate, winterized oil composed of long-chain mono-, di-, and tri-glycerides, medium chain tri-glyceride based lipids, and mixtures thereof.

7. The dosage form according to any one of the preceding claims, wherein the dosage form is a capsule filled with the crosslinked poly(vinyl pyrrolidone) loaded with the self-emulsifying composition.

8. The dosage form according to any one of claims 1 or 7, wherein the dosage form is a tableted dosage form obtained by tableting the crosslinked poly (vi nyl pyrrolidone) loaded with the self-emulsifying composition with a matrix building component, and, optionally, a tableting aid.

9. A method for preparing a solid self-emulsifying dosage form comprising- emulsifying the self-emulsifying composition in water to obtain an emulsion,- loading the emulsion onto crosslinked poly(vinyl pyrrolidone) to obtain a wet powder of loaded crosslinked poly(vinyl pyrrolidone), and- drying the wet powder.

10. The method according to claim 9 comprising filling the dried powder into a capsule to obtain the solid self-emulsifying dosage form.

11. The method according to claim 9 comprising tableting the dried powder with the matrix building component, and, optionally, the tableting aid to obtain the solid self-emulsifying dosage form.

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