MXPA97004847A - Filling material for the dosage form of gelatin bla - Google Patents

Abstract

The present invention relates to a semi-solid, substantially translucent filler material for a soft gelatin capsule, which contains a therapeutically effective amount of a pharmaceutical product dissolved or suspended in the semi-solid. The semi-solid is sufficiently viscous so that it can not be easily expelled at the ambient temperature of the capsule, with a syringe

Description

FILLING MATERIAL PflRfl FORM OF PHARMACEUTICAL DOSAGE OF SOFT GELATINE FIELD OF THE INVENTION The present invention relates to a soft gelatin capsule filled with an ernisoli or containing a therapeutically effective amount of a dissolved or suspended aromatic ingredient in the semisolid and, in particular, to a sernisolide filler material which »It has a substantially translucent appearance. This invention is also related to U.S. Patent Applications Serial No. 08 / 366,945, filed December 29, 1994, entitled "Soft Gelatin Pharmaceutical Dosage Form"; Serial No. 08 / 366,271, filed on December 29, 1994, entitled "Gelifying Agent for Pol? Et i Lengolol"; Serial No. (Proxy Case No. P1CP.160), filed on, titled "Filler material for pharmaceutical dosage form of soft gelatin, containing anti-latulonto n"; and Serial No. (Proxy Case No. MCP-166), filed by the, entitled "Soft gelatin dosage form, phase III," which are all assigned to the same successor as the present invention, and all They are incorporated here as reference.

BACKGROUND OF THE INVENTION In recent years, soft gelatin capsules or soft elastic gelatin capsules have become a popular dosage form for the oral delivery of therapeutic agents, especially for over-the-counter pharmaceutical products. These capsules are typically filled with a liquid containing the active ingredient. Due to their soft and elastic nature, some patients see these capsules as easier to swallow than tablets or hard gelatin capsules. Since the dosage form is generally swallowed, it is not necessary to flavor or otherwise mask the often unpleasant taste of the pharmaceutical product. Soft gelatin capsules are also preferred to loose liquids because they are easier to transport and avoid the need for the patient to have a prescribed amount of liquid before the dose. The filling material used in a soft gelatin capsule generally contains a pharmaceutical product dissolved or dispersed in a carrier that is compatible with the capsule wall. In addition to liquids, U.S. Patent No. 4,935,243 to L. Boran and co-inventors suggests that the filler material may take the form of a semi-solid, a solid or a gel. Conventional tablets or pills containing an active ingredient are examples of solid fillers that can be encapsulated within a soft gelatin capsule. The filler materials used alone (dispersions) are discussed in US Patent No. 4,486,412, by D. Shah and co-inventors. A filler material containing an orally administered antacid salt, which is dispersed in a liquid carrier without water, containing a higher proportion of one or more polyalkylene glycols and a minor proportion of a polio of 2 to 5 carbon atoms, such as propylene glycol or glj cerine. The carrier forms a stable dispersion of the antacid salt and covers the antacid particles, thus rendering them nonreactive with the soft gelatin capsule wall. U.S. Patent No. 4,708,834 to Cohen and co-inventors suggests a controlled dose pharmaceutical dosage form comprising a soft gelatin capsule enclosing a gelled poly-epica matrix, soluble or water-dispersible. The filler material comprises an aqueous solution or dispersion of a polysaccharide go, the pharmaceutically active ingredient and, optionally, an alcohol. The liquid filling is introduced into a soft gelatine capsule containing a cationic gelling agent, which gels the liquid filling after it has been incorporated into the cap of the capsule. The alcohol used in the filling includes liquid polyethylene glycols, lower alkanols, polyols of 2 to 4 carbon atoms, and mixtures thereof.

U.S. Patent No. 5,071,643 to M. Yu and co-inventors also describes the use of polyethylene glycol (PEG) as a filler in soft gelatin dosage forms. PEGs that have an average molecular weight between 400 and 600 are preferred for liquid fillings; between 800 and 10,000 for semisolid fillings and between 10,000 and 100,000, for solid fillings. Remmgton's Pharrnaceutical Sciences, 18a. Edition, Chapter 83, pages 1539-40 (1990) reports that gelling agents used to form gels for pharmaceutical and cosmetic products include sodium alginate and tnetanol mine. The publication of the TCP No. UO 91/07950 discloses a soft gelatin capsule or two piece hard gelatin capsule, containing benzodiazepine dissolved or suspended in a gel. The gel contains, by weight, at least 63% by weight and 600%, at least 4% by weight of 4,000 or 6,000 polyethylene glycol; and at least 21% of polieti Lengolol 600-4,000. This gel r-elleno can not be easily expelled with a syringe at room temperature and, therefore, avoids the reported abuse of liquid-filled capsules by intravenous drug abusers. As reported in example 1 of the present application, the gels containing this mixture of polyethylene glycols have an opaque appearance. There is a need for a substantially translucent, sernisolide backfill material, < < It can be used in the production of soft gelatine capsules. The r-ellene material should also be sufficiently viscous to prevent it from being expelled from the cap of the capsule with a syringe.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides a r-ellene material for a soft gelatin capsule comprising a polyalkylene glycol having an average molecular weight of about 600 or less; a thickener in an amount effective to thicken the glycol, to form a semi-solid and, optionally, water. A therapeutically effective amount of a pharmaceutical substance is dissolved or suspended in the sernisolide, and the gel will be solid having a stiffness of less than about 1,300 UTN (Nefelometric Turbidity Units). The sernisolide of the present invention has a substantially translucent appearance and when used to fill a soft gelatin capsule, which is also translucent, the resulting dosage form has an elegant, substantially translucent or clear appearance. In another embodiment of the present invention the sernisolide is sufficiently viscous so that it can not be easily expelled at room temperature from the capsule with a syringe that preferably has a 16 gauge or smaller needle.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The present invention relates to a substantially translucent semi-solid for filling in a pharmaceutical dosage form of a soft gelatin capsule. The isolide can also be used to fill a two-piece hard gelatin capsule. The viscosity of the sernisolide is also controlled so that the r-ellene can not be easily removed from the capsule with a syringe at room temperature. This aspect helps protect against possible intravenous abuse of the drug as well as the violation or falsification of the product. As used in the present description, a sernisolide is a system of at least two constituents that consist of a condensed mass that encloses, and is interpenetrated by, a liquid. The semi-solid filler material is sufficiently viscous that an appreciable amount, less than about 1, preferably less than about 0.5 g, can not be expelled at room temperature with a syringe having a 16 gauge needle or less. . The isolide preferably has a viscosity at 25 ° C of at least about 30,000, most preferably at least about 200,000 centipoise (cP). The viscosity of the sernisolide is generally less than 500, 000 cP, approximately. The nisolide of the present invention contains a liquid polyolylene glycol having an average molecular weight of about 600 or less. The polyalkylene glycol serves as a solvent for the pharmaceutical product. A suitable polyalkylene glycol is polyalkylene glycol. The polyethylene glycols preferably have an average molecular weight of about 200 to 600, and most preferably about 300 to 400. The sernisolide generally comprises in the amount of about 35 to 99, preferably about 85 to 99%, solvent. Unless indicated otherwise, the percentages mentioned in this ßon in? E <; =, or with respect to the total weight of the semi-solid filler material, that is, both the sernisolide and the active ingredient. The solid sepu is formed by thickening the solvent with cellulose ethers. A suitable cellulose ether is hydroxypropyl cellulose. Preferably, the thickener is hydroxypropylcellulose, NF having a molecular weight of about 80,000 1,150,000. The hydroxypropylcellulose, NF can be obtained commercially from Aqualon, Inc., under the brand name KLUCEL (R), and the preferred grades are KLUCEL GF, MF and HF, which have a molecular weight scale of about 370,000 to 1,150,000. The lower molecular weight hydroxypropylcellulose, which includes KLUCEL EF, LF and JF, which have a scale of approximately 80,000 to 140,000, can also be used, but generally at higher concentrations than with the higher molecular weight grades. In a preferred embodiment, the thickening agent is employed in an amount effective to form a semi-solid that is substantially translucent and sufficiently viscous, so that it can not be expelled at room temperature with a syringe having a gauge needle. 16 or less. Generally, the semi-solid contains, by weight, from 0.10 to 10, and preferably from 0.25 to 3.5%, approximately, of one or more of the cellulose ethers. In addition to the polyalkylene glycol, the isolide ester may contain solubilizing agents to increase the solubility or the solubility of the active ingredient in the serbisole.

Suitable agents include propylene glycol, glycepine, ethanol, N-met? I-2-? rrolidone, dimetili soßorbide, povidone (PVP), poloxamer, other pharmaceutically active agents and their mixtures. A preferred poloxarnero (copolymer of poly (oxyethylated) -polyloxypropylene)) is Poloxarner 124, obtainable from BASF under the trademark PLURONIC L 44. Generally, the solids do comprise from about 0 to about 8, preferably from 0 to 6%, approximately, of solubilizing agent. In addition, the sernisolide may contain from 0 to 10%, approximately, of water. If acetaminophen, famot idma, ra tidem, citrine or other easily oxidizable substance is used as an active ingredient, it may be advisable to include an antioxidant to eliminate degradation or discoloration, such as the "rosé" of the acetic acid. arn mofen. The active ingredient or active ingredients are present in the dosage form in a therapeutically effective amount, which is an amount that produces the desired therapeutic response by oral administration, and can be easily determined by who is an expert in the field. In determining such quantities, the particular compound being adrmmetered, the bioavailability characteristics of the compound, the dose regimen, the age and weight of the patient, and other factors must be taken into consideration. The pharmaceutical products suitable for use in the invention include: acetaminophen, farno-t di na, chlorphenira ine, pse? doefedpna, dextromethorphan, diphenhydramn, brornfeni ranin, clernastma, phenylpropanolarnin, terfenadna, astemizole, loratadma. , ida, N-oxide of lorernide, ramtidine, cytidine, tramadol, cisappde, acetylisalicylic acid, doxy euccinate Lamina, their pharmaceutically acceptable salts and mixtures thereof. In general, the pharmaceutical product comprises about 0.1 to 40, preferably 0.2 to 30% by weight of the total ß-emethyolide composition. Various other pharmaceutically acceptable excipients may be included in the ßernieolide filler material, such as preservatives, for example, methyl or propylparaben; coloring agents, sabotagers, lubricants, flow enhancers, antioxidants, surfactants, plasticizers, fillers and other compounds, agents and components, which produce an attractive final product. In a preferred embodiment a filling for a soft gelatine capsule containing about 180 g / ml of acetapunofen, comprises, by weight, around LO at 40% acetaminophen, around 40 to 90% polyethylene glycol, which has an average molecular weight of 400 (PEG 400); from 0 to about 8% of water, from 0 to about 8% of propylene glycol and from 2 to 8%, approximately, of hydroxypropyl-reulose. In another preferred embodiment, a filling for a soft gelatin capsule containing from 10 to 40 mg / l of farnotidine, comprises, by weight, about 0.5 to 4% of farnotidm, of 60 to 99% by weight of PEG 400; from 0 to about 8% water; from 0 to about 8% propylene glycol and from 2 to 8% hydroxypropylcellulose. In a further preferred embodiment, a r-elleno couple to a soft gelatine capsule containing 17 g / rnl of loperated hydrochloride comprises, by weight, about 1 to 3% of loperated hydrochloride, from 92 to 99% of PEG 400; from 0 to about 8% water, from 0 to 8% propylene glycol and from 0.5 to 3% hydroxypropylcellulose. The filler material of the present invention can be used in commercially available soft gelatine capsules, such as those which can be obtained commercially from R. P: Senerer or Banner Pharmacae. You can use different sizes, shapes and colors to accommodate different levels of active ingredients. The capsules of the capsules have a substantial translucent or clear appearance. When the filling material of the present invention is introduced into the capsule and form? N sernisolide, the resulting dosage form has an elegant, translucent or clear appearance. The r-ellene material generally has a less than about 1,300 haze, preferably less than about 200 UTN. The filling material is heated before being loaded into the capsule, because temperatures below 40 ° C are highly viscous. You can handle soft gelatin capsules filled with air, filled with a syringe. The hot liquid filling is loaded into a syringe. The needle of the syringe is used to puncture one end of the soft gelatin capsule, so that the approximate amount of the filling material can be injected manually. Allow the capsule to cool with the filling material. The filling material can also be introduced into the soft gelatin capsule using encapsulation equipment known in the art, such as that described in US Patent No. 4,08,024 to Moreland, which is incorporated herein by reference. . As previously described with the hand filling technique, the filling should be maintained at around 40 ° C during the filling operation, so that it flows easily into the capsule. Accordingly, the filler can be stored in a jacketed container and can be transported through a feed tube controlled by means of a thermostat to the encapsulation equipment. Specific embodiments of the present invention are illustrated, by way of the following examples. This invention is not confined to the specific limitations set forth in these examples, but rather to the scope of the appended claims. Unless otherwise stated, the percentages and the proportions given in advance <; on in weight with respect to The total composition. The turbidity of the filler materials described in the following examples was measured using a Hach Ratio / XR Turbidimeter turbidity meter. The United States Pharmacopeia defines the turbidity with the light diffusing effect of the suspended particles, and the turbidity as the measure of the decrease in intensity of the incident ray per unit length of a given suspension. This insurement measures turbidity within a range of 0.00 to 2,000 NTU. As a reference point, the turbidity of the water is zero. Samples of the fill materials, approximately from R mi, were transferred to Fisher Brand culture tubes of 13 x 100 mm, immediately after manufacture. The samples of filling material were stored at room temperature, since they were prepared several days in advance. The outer surface of each of the sample culture tubes was treated with Eiltcon oil just L3 before measuring The stiffness. The turbidity of the samples was measured at room temperature. The turbidity of two sample tubes of each filling material was measured and the average of the results is reported. The viscosity was determined in the following examples using a Rheometrics 8400 fluid spectrometer at 25 ° C. Using a parallel plate of 25 nm and a constant voltage of 10%, frequency sweeps were performed. The viscosity was recorded at a frequency of 1.0 radians per second. The dissolution test was carried out in the following examples using USP type I baskets, fixed at 100 rprn, and an acetate regulator (pH 4.7) with pepsin as medium. The volume was 500 nl, the USP limits are 80% of TMN in 30 minutes. An amount of the formulation equivalent at a dose of 4.0 mg of loperamide hydrochloride was tested in a soft gelatin capsule, cut in half. 1 Lev out The syringe manipulation test in The following example to measure the ability to syringe said formulation, within a p > controlled time epode. Eßta test co or a measure of the resistance to the violation was used. Syringes of 10 cc were used with 16 gauge needles, 3.81 cm long. The syringe was placed in the formulation, pulled up on the plunger and resisted for 10 seconds. The weight of the material brought to the syringe was recorded.

EXAMPLE 1 This example provides a comparison of PEG mixtures similar to those described in the TCP publication UO 91 / 07950. The following mixtures were prepared: Quantity (% w / w) Component Sample A Sample B PEG 600 64.40 64.40 PEG 1450 26.20 26.20 PEG 3500 - 4.20 PEG 8000 4.20 Glycerol 5.20 5.20 The samples were prepared as follows: 1) p > eyed the PEG and the glycerol. i) The mixture was placed on a hot plate previously greased, fixed or set higher. Mixed with heat (approximately 75 ° C) until a clear solution is obtained. 3) The mixture was removed from the heat and mixed. It was sonically treated with a temperature setting of 69 ° C. When rewetting at room temperature to form a gel, both samples had an opaque white appearance, with a turbidity of 2,000 UTN.

EXAMPLE 2 This example describes a filler material of the present invention which contains about 180 mg / rnl of acutaminophen. Fill F contains: Component Quantity (% weight / weight) Acetamofen 20.0 PEG-400 (molecular weight 400) 75.7 Hydroxypropylcellulose 4.3 (KLUCEL GF, molecular weight 300,000). The sample is prepared in the following manner: J) PEG-400 is heated to 110-120 ° C and acetaminophen is added slowly, while stirring. 2) After the acotammofen is in solution, the hydroxypropylcell is added with agitation. 3) After the appearance of the resulting mixture is that of a clear solution, it is allowed to cool to room temperature.

EXAMPLE 3 This example describes a filling material of the present invention which contains 10 rng / rnl of famotidma. The filling material contained: Component Quantity (% weight /? Eeo) Farnotidma 1.6 PEG 400 (molecular peptide 400) 91.3 Hydroxypropyl cellulose 7.1 (KLUCEL GF, molecular weight 300,000) The sample was prepared as follows: 1) PEG-400 was heated at 110-120 ° C and the sample was slowly added. Droxipropylcellulose, while stirring. 2) After the hydroxyl propylene cell remained in solution, the formulation was cooled to 70 ° C. 3) Famotidine was added while stirring. 4) After the resulting mixture had a clear solution appearance, it was allowed to cool to room temperature to give a clear semisolid. The turbidity of the resulting sample was 14.6 UTN.

EXAMPLE 4 This example describes a self-contained filling material of the present invention which contains 17 rng / rnl of the hydrocarbon obtained. The filling materials contained: Component Quantity (% weight / weight) Hydrox ipropylcellulose (KLUCEL HF, molecular weight 1,150,000) 1.5 PEG 400 (molecular weight 400) 89 Loperamide Hydrochloride 1.5 Poloxarnero (PLURONIC L-44) 8 The sample was prepared as follows: 1) PEG 400 was heated and the poloxarnero at 100 ° C and the hydroxy propyl cellulose was slowly added while stirring at high speed on a hot plate. 2) After the hydroxyborate was left in solution, the formulation was cooled to around 70 ° C. 3) Hydroxypropyl cellulose was slowly added while stirring. 4) After the resulting mixture had the appearance of a clear solution, it was cooled to room temperature to give clear ßernisolide. The resulting formulations were allowed to cool to room temperature to give a clear semi-solid.

EXAMPLE 5 This example describes sernisolide filler materials containing 17 mg / ml of loperated hydrochloride. The filling materials contained: Component Quantity (% weight / weight) A B Hydroxypropylcellulose (KLUCEL NF, molecular weight 850,000) 3.0 3.0 Propylene glycol - 6.0 PEG 400 95.5 89.5 Clorhi drato de loperami da 1 .5 1 .5 The samples were prepared as follows: 1) PEG 400, propylene glycol and hydroxypropylcellulose, were weighed in a beaker. 2) It was mixed at high speed on a hot plate, regulated at around 120 ° C, until the polymer completely dissolved. 3) The heat was reduced approximately to 70 ° C and the chlorohydrate of ida lopera was added; It was mixed until it dissolved. The resulting formulations were allowed to cool to a clear solid serní.

EXAMPLE 6 This example describes a solid filler material containing 17 mg / ml loperamide hydrochloride. The filling material contained: Component Quantity (% weight / weight) Hydroxypropylcellulose (KLUCEL HF, molecular weight 1,150,000) 1.5 Propylene glycol 5.5 PEG 400 41.5 Loperamide hydrochloride 1.5 The sample is prepared as follows: 1) PEG 400, propylene glycol and hydroxypropylcellulose are weighed in a beaker . 2) Mix at high speed on a hot plate, regulated at approximately 120 ° C, until the polymer is completely dissolved. 3) The heat is reduced to approximately 70 ° C and the loperated hydrochloride is added, mixed until it dissolves.

The resulting formulation is allowed to cool to room temperature to give a clear isolide.

EXAMPLE 7 This example describes a sernisolide filler material containing 17 mg / l of loperamide hydrochloride Component Canti da (% w / w) Hydrox propi 1 ul (KLUCEL MF, molecular weight- 850,000) 2.7 Propylene glycol 5.5 PEG 400 90.3 Lopera ida 1.5 hydrochloride The sample was prepared as follows: 1) PEG 4000, propylene glycol and hydroxypropyl ether were weighed. propilcel? slab, in a beaker. 2) It was mixed at high speed, on a hot plate, regulated at approximately 120 ° C, until the polymer completely dissolved. 3) The heat was reduced to approximately 70 ° C and the loperamide hydrochloride was added, mixed until dissolved. The resulting formulation was allowed to cool to room temperature to give a clear semisolid. The following summarizes the results of the sample test for examples 1 and 3-7 »Management with Clan Vi scosi ad E empJ.o syringe (g) (UTN) (cPs) A - > 2,000 IB - > 2,000 3 14.6 4 0.06 69,810 5A 0.08 34 18,200 5B 0.06 21 87,870 6 0.32 5.5 78.070 7 0.23 10.2 156.900 Robitussi níR) iqui- Gel s (R) 1.6 Dr? Xoral (R > To s Liquj - • Gel sCR) 3.2 Water 11.5 EXAMPLE 8 This example describes a soft gelatin capsule filled with a sernisolide filler material containing 17 mg / ml of loperated hydrochloride. The following sample was prepared: Component Quantity (X weight / weight) Hydrox and pr-opycellulose (KLUCEL MF, molecular weight 850,000) 2.7 Propylene glycol 5.5 PEG 400 90.3 Loper ami hydrochloride at 1.5 The sample is prepared from the following table: 1) PEG 400, propylene glycol and hydroxypropylcellulose are weighed, in a beaker. 2) It was mixed at high speed on a hot plate, regulated at approximately 120 ° C, until the polymer completely dissolved. 3) Approximate heat was reduced to 70 ° C and the hydrochloride was added., it was mixed until it dissolved. The resulting formulation was allowed to cool to room temperature to give a clear, solid solid with an approximate water content of 7.0 UTN, a solution of about 0.05% of the desired hydrochloride in 30 minutes, and a capacity of handling with syringe of approximately 0.40 g. The solid was heated so that it flowed and Game was filled with ol capsules of soft gelatin hydrhobas or hydr-ofilaß, in the following manner: 1) The cylinder of a syringe of 10 ce was filled with the formulation of hydrochloride of loperarnida , without the needle. 2) A 16 gauge needle was attached and placed inside a soft gelatin capsule filled with air, previously weighed. 3) A dose of 2 mg of loperamide hydrochloride in the capsule filled with air-e was carefully injected with the syringe. 4) The upper end of the capsule filled with air is sealed, 00 with a hot iron. The resulting soft gelatin capsules had a substantially translucent appearance. Various modifications can be made in the embodiments described above, without departing from the spirit and scope of the present invention.

Claims (5)

1. NOVELTY OF THE INVENTION CLAIMS 5. A pharmaceutical composition, characterized in that it comprises: a sernisolide comprising a polyalkylene glycol having an average molecular weight of about 600 or less, and a cellulose ether in an effective amount to thicken the polyalkylene glycol. icol; a therapeutically effective amount of a pharmaceutical product, dis- or suspended in said semi-solid; and the composition has a turbidity less than about 1,300 UTN.
2. 2. The composition according to claim 1, further characterized in that the polyalkylene glycol is poiet i lengl icol.
3. 3. The composition according to claim 1, further characterized because the peat ez eß less than about 200 UTN.
4. 4. The composition according to claim 20, further characterized in that it comprises additional propylene glycol.
5. 5. The composition according to claim 1, further characterized in that it comprises, by weight: about 35 to 99 percent, of the polyalkyl-il-glycol; from 0 to about 10% of propylene glycol; from 0 to around- 10% water; and about 0.1 to 10% of the cellulose ether. 6. - The composition according to claim 5, character? Furthermore, it comprises polyethylene glycol having an average molecular weight of about 200 to about 600. The composition according to claim 1, further characterized in that the cellulose ether is hydroxypropallated. 8- The composition according to claim 7, further characterized in that the cellulose ether is hydropropylcellulose having a molecular weight of about 80,000 to 1,150,000. 9. The composition according to claim 1, further characterized in that said pharmaceutical product is selected from the group consisting of acetama nofen, farnotidma, chlorpheniramine, pseudoephedrine, dext rornet or ano, diphenylhydranine, brompheniramine, clemastidma, rpropanolamine, terfenadine, aetemizole, loratadine, peroxide, N-oxide of Loperamide, ranitidine, cytidine, tramadol, cißapride, acetylealicylic acid, doxylaninate succinate, their pharmaceutically acceptable saltse and mixtures thereof. 10. The composition according to claim 1, further characterized in that the semi-solid comprises polyethylene glycol having an average molecular weight of 300 to 400, approximately, and hydroxypropyl cellulose. 11. The composition according to claim 5 10, further characterized in that it comprises, by weight: about 85 to 99 percent, of polyethylene glycol having an average molecular weight of about 300 to 400; from 0 to about 8 percent propylene glycol; and from about 0.25 to 3.5 percent, a hydroxypropyl cellulose having an average molecular weight of 300,000 to 1,200,000, ap rox irnadament. 12. The composition according to claim 1, further characterized in that it has a viscosity of at least 30,000 cen ipoa ses. 13. - The composition according to claim 12, further characterized in that it comprises, by weight: about 1 to 3 percent, of loporarnide hydrochloride; about 92 to 99 percent, of polyethylene glycol having an average molecular weight of about 400; from 0 to about 8 percent water; from 0 to around 8 per slow of pr opi langl icol; and from 0.5 to 1 percent, approximately, of hydroxypropylcellulose. 14. The composition according to claim 1, further characterized in that it comprises, by weight: about 89 percent polyethylene glycol having an average molecular weight of about 400; about 8 percent copolymer of poly (ox? et? leno) -poly (oxypropylene); Approximately 1.5 percent hydroxypropylcellulose and approximately L.5 percent bound chlorhydrate. 15. - A pharmaceutical dosage form, characterized in that it comprises: a gelatin capsule shell, filled with a semi-solid that contains a therapeutically effective amount of a pharmaceutical product dissolved or suspended in the sernisolide; and the ßernisolide containing the pharmaceutical has a turbidity less than about 1,300 UTN. 16. The dosage form according to the r-ei vindication 15, characterized in that the turbidity of the solid is less than around 200 UTN. 17. The dosage form according to claim 15, further characterized in that the semi-solid comprises a solvent and a thickening agent. 18. The dosage form according to claim 17, further characterized in that the solvent is a polyalkylene glycol having an average molecular weight of not more than 600 or less; and the thickener is an ether-cellulose in an effective amount to thicken the solvent. 19. The dosage form according to claim 18, further characterized in that it additionally comprises propylene glycol. 20. The dosage form according to claim 18, further characterized in that the polyalkylene glycol is polyethylene glycol. 21. The dosage form according to claim 18, further characterized in that it comprises, by weight: about 35 to 99 percent, of polyalkylene glycol; from 0 to about 10 percent of μropí lengl i col; from 0 to about 10 percent water; and from about 0.10 to 10 percent of the cellulose ether. 22. The dosage form according to claim 21, further characterized in that it comprises polyaliyl glycol having an average molecular weight of about 200 to 600. 23. The dosage form in accordance with the claim. 18, further characterized in that the cellulose ether is hydroxypropa cellulose. 24.- The dosage form according to claim 23, further characterized in that the cellulose ether is hydroxypropylcellulose having a molecular weight of 80,000 to 1,150,000, suitably. 25. The dosage form according to claim 15, further characterized in that said pharmaceutical product is selected from the group consisting of acetarninophen, farnotidine, chlorpheniramine, pseudoephedrine, dextromethorphan, diphenhydride ina, romfeniramma, clernastidine, phenylpropanole ina, terfenadine, astemizole , loratadine, lope ramada, N-oxide of loperamide, ranitidine, cimetidine, l-screen, cisapride, acetal isalicylic acid, doxy lami nato succinate, pharmaceutically acceptable suß ßalee and mixtures thereof. 26. The dosage form according to claim 18, further characterized in that the sernisolido comprises polyethylene glycol having an average molecular weight of about 300 to 400, and hydroxypropylcellulose. 27. The dosage form according to claim 26, further characterized in that it comprises, by weight: about 85 to 99 percent, of polyethylene glycol, propylene glycol or mixtures thereof, having an average molecular weight of 300 to 400, approximately; from 0 to about 6 percent propylene glycol; and from 0.25 to 3.5 percent, approximately, of hydroxypropylcellulose which has an average molecular weight of 300,000 to 1,200,000, approximately. 28. The dosage form according to claim 15, further characterized by having an iscosity of at least 30,000 centipoise. 29. The dosage form according to claim 28, further characterized in that it comprises, by weight: about 1 to 3 percent, of loperated hydrochloride; about 92 to 99 percent of polyethylene glycol having an average molecular weight of about 400; from 0 to about 8 percent water; from 0 to about 8 percent propylene glycol; and from 0.5 to 3 percent, approximately, of hydroxypropylcellulose. 30. The dosage form according to claim 15, further characterized in that the cover is a soft gelatin capsule. 31. - The doßiß form according to claim 17, further characterized in that it comprises, by weight: about 89 percent polyethylene glycol having an average molecular weight of about 400; about 8 percent copolymer of poly (oxyethylene) -poly (oxypropylene); approximately 1.5 percent of hydroxypropane 1 cellulose and about 1.5 percent of ida hydrochloride.