WO2000054812A1

WO2000054812A1 - Improved composition for oral administration

Info

Publication number: WO2000054812A1
Application number: PCT/AU2000/000175
Authority: WO
Inventors: Michael Mendel Monk
Original assignee: Michael Mendel Monk
Priority date: 1999-03-12
Filing date: 2000-03-13
Publication date: 2000-09-21
Also published as: AUPP915099A0

Abstract

The invention provides an orally-administrable gelatinous composition, an orally-administrable preparation capable of forming a gelatinous composition and a method of improving the palatability of an orally-administrable medicament relative to the medicament alone by forming a gelatinous composition.

Description

Improved composition for oral administration

Technical Field

The piesent invention ielates geneiallv to impioved compositions foi 01 al admimsti ation and to methods foi obtaining such compositions Backgiound Ait

Phaimaceutical medicaments aie used to heat and provide relief to individuals suffeimg from a vast lange of diseases and ailments Along with impioved nutntion and living conditions in developed communities, phaimaceutical medicaments have impioved human health and quality of life Much leseaich has been dnected to the isolation and detection of the active components of plant diugs and to the manufacture and distribution of potent synthetic drugs The plethoia of pharmaceutical medicaments on the maiket today is indicative of the importance of pharmaceutical medicaments in oui society The majority of ovei-the-countei phaimaceutical medicaments obtained from a phaimacy lequne oial admimstiation These medicaments generally take the form of a tablet capsule, liquid or powder which requires administration with water oi other fluids It is often the case that duπng admimstiation of any one of these medicaments, the consumer will be able to smell and/or taste the mgiedients of the medicament The problem with the oial admimstiation of medicaments is the fact that they often have an unpleasant taste oi odoui making them geneiallv unpalatable This is especially lelevant in treating infants, children or people adverse to taking orally admimstrable medication For example, dehydration is a majoi illness following mainly from infections or viral gastroenteritis Viral gastroenteritis causes diarrhoea and vomiting which leads initially to mild dehydration and which may develop into severe dehydration and there foi e a life tmeatening illness It is essential, therefore, that the patient is lehydrated and that further dehydration is prevented The medicament commonly used to treat dehydration consists of essential salts, minerals and glucose and when mixed with watei. is able to provide the correct fluid which would assist in the rehydration of the patient The mam pioblem with this medicament is that since it is mainly made up of salts and acids such as sodium chloride. sodium acid citrate and potassium chloride, a somewhat unpleasant taste is left in the mouth during and after consumption Such a medicament, therefore, does not have great acceptance to the consumer, especially when infants and children are the sufferers of the condition. The addition of flavour or fruit flavour to the composition to try and mask the unpleasant taste has been only moderately successful and there is still much resistance to taking such products by infants and young children.

There are a variety of drugs on the market today in which the components of the pharmaceutical medicament are encapsulated in a dissolvable casing such as a gelatin casing. This enables a pharmaceutical medicament to be administered to a patient in capsule form without the patient having to tolerate adverse tastes and/or odours of the medicament.

However, this encapsulated formulation is not available, and in some cases is not suitable, for all pharmaceutical preparations. While a number of medications are prepared in this manner, they are not necessarily more appealing or suitable for a younger child or to any person who has trouble administering drugs in the form of tablets or capsules.

The present inventor has surprisingly found a method of improving the palatability of a medicament which is required to be orally administered. In particular, the present inventor has found that the addition of a gelling agent to a medicament to be orally administered forms a gelatinous composition which surprisingly masks the unpalatable tastes, odours and textures associated with the medicament when administered on its own in an un- gelatinous form. Disclosure of the Invention

In a first aspect, the present invention is directed to an orally- administrable gelatinous composition comprising a gelling agent and a medicament, wherein the gelatinous composition has improved palatability relative to the medicament when administered alone.

In a second aspect, the present invention is directed to an orally- administrable preparation comprising a gelling agent and a medicament. wherein when the preparation is hydrated a gelatinous composition is formed which has improved palatability relative to the medicament when administered alone.

In a third aspect, the present invention is directed to a method of forming a gelatinous composition according to the first aspect of the invention, the method comprising combining the medicament with a gelling agent in a manner so as to form a gelatinous composition which has impioved m palatability lelative to the medicament when administered alone

In a fouith aspect, the piesent invention is directed to a method of lmpiovmg the palatability of an oiallv-admimstrable medicament with unpalatable chaiacteπstics the method comprising combining the medicament with a gelling agent in a mannei so as to form a gelatinous composition which has improved in palatability relative to the medicament alone

In a fifth aspect, the piesent invention is directed to the use of a gelling agent in the preparation of an oialh -admimstrable gelatinous composition for the treatment of a medical condition wherein the gelling agent is combined with a medicament with unpalatable chaiacteπstics to form the gelatinous composition which is improved m palatability relative to the medicament when administered alone In a sixth aspect, the present invention is directed to a gelatinous composition containing a medicament which has improved palatability relative to the medicament alone piepared according to the method of the fourth aspect of the present invention

In a seventh aspect, the present invention consists m a method of treating a medical condition, the method comprising administering to a subject in need of treatment an orally-administrable gelatinous composition according to the first aspect of the present invention or an orally- admmistrable preparation according to the second aspect of the present invention The orally-administrable medicament or medicaments with an unpalatable characteristic or characteristics to be improved will hereinafter be referred to as "the medicament' The gelatinous composition containing the medicament with improved palatability relative to the medicament alone will hereinafter be referred to as "the gelatinous composition" The term "medicament" is intended to include any one or more substances used to treat a medical oi improve a health condition

The teim "unpalatable characteristics" is intended to mean the one or more characteristics of the medicament which are unpleasant to the consumer or patient when orally administered These characteristics include but not limited to taste, odour or texture of the medicament to be orally administered The present invention is applicable for use with a variety of medicaments. If required, the gelatinous composition mav include one or more medicaments. The medicament may be in solid, powder, liquid, syrup or elixir form. In most cases, the medicament has an unpalatable taste and/or odour. The medicament may be in the form of rehydration mixtures (that is. a mixture for oral dehydration therapy (ORT)) which usually include essential salts such as sodium chloride, sodium acid citrate, potassium chloride and optionally ingredients such as glucose, aspartame and phenylalanine: analgesic and anti-inflammatory preparations such as paracetamol and ibuprofen: antibiotics such as erythromycin: and antihistamine preparations including promethazine. It will be appreciated, however, that the present invention is not limited to these medicaments. It has surprisingly been found by the present inventor that when a medicament with adverse or unpalatable characteristics is combined with a gelling agent to form a gelatinous composition, the unpalatable taste and/or odour of the medicament is masked in the resulting gelatinous composition. The term "gelatinous composition", is intended to mean jelly-like in form or pertaining to or resembling gelatin when in solution. It will be appreciated that the rigidity of the gelatinous composition will be affected by many factors including temperature, thermal history, the presence and concentration of electrolytes, non-electrolytes and other ingredients. The strength of a gel is measured in Bloom and the gelatinous composition of the present invention may have a Bloom strength of between approximately 50 - 300 Bloom. More preferably, the gelatinous composition of the present invention has a relatively elastic texture and a relatively high Bloom value.

A variety of gelling agents which are biocompatible and capable of forming a gelatinous composition when in solution may be employed in the present invention. By "biocompatible" it is intended to mean that the gelling agent is suitable for oral administration without undue toxicity or physiological or pharmacological effects to the subject consuming the substance.

The gelling agent may be selected from the group consisting of gelatin, warm water fish gelatin, isinglass, gums such as xanthan gum and gellan gum. various types of agar and mixtures thereof. It will be appreciated, however, that the present invention is not limited to these gelling agents as other agents may also have the ability to mask or overcome adverse or unpalatable characteristics of a medicament when used according to the present invention. Preferably, the gelling agent is gelatin, xanthan gum or mixtures thereof.

The viscosity of the resulting gelatinous composition depends on a number of variables including salt content. pH and the temperature of the composition and the concentration of gelling agent. The viscosity of a gelatin solution, for example, increases with increasing concentration of gelatin and decreasing temperature. In salt-free solutions, minimum viscosity occurs at the pH of the iso-ionic point of the gelatin. The viscosity of gelatin will also effect the gel properties including setting and melting point. High viscosity gelatins give gels with a higher melting and setting temperature as well as producing a quicker setting rate than do gelatins of lower viscosity.

The gelatinous composition may be prepared in a number of ways including combining the medicament with the gelling agent followed by the addition of a solvent, combining a solution of the gelling agent with the medicament or by combining a solution of the medicament with a solution of the gelling agent. In cases where the medicament is in a powdered form, the gelatinous composition may be prepared by adding a solvent to a powdered mixture of the medicament and gelling agent. In most instances, the solvent will be water.

Preferably, the gelling agent is used in a concentration of approximately 0.05% w/v to 15% w/v. More preferably. 0.25% w/v to 7% w/v and even more preferably. 0.5% /v to 3% w/v.

The gelatinous composition may. for instance, be formed using approximately 5 to 15 g of gelling agent in 400 to 600 iriL of solvent, preferably, 8 to 12 g of gelling agent per 450 to 550 mL of water.

As noted above, the viscosity and rigidity of the resulting gelatinous composition may be affected by the concentration of the gelling agent. For example, when xanthan gum is used as the gelling agent in a concentration of 0.5% w/v and is combined with either paracetamol or a rehydration mixture such as Gastrolyte® (Commercially available from Rhone-Poulenc Rorer Australia Pty Ltd), a slightly viscous liquid is formed. An increase in concentration of the xanthan gum to 1.5% w/v resulted in a moderate viscous liquid with elastic properties while increasing the concentration of gelling agent to 3% w/v resulted in a highly viscous liquid with elastic properties. The combining of the gelling agent and the medicament to form the gelatinous composition may take place at any suitable temperature and will depend on the nature of the medicament and other factors such as the concentration and particle size of the gelling agent and the pH of the composition. The temperature of the solution containing the medicament and the gelling agent may be raised to allow the gelling agent or both ingredients to dissolve, preferably above approximately 40°C. and then lowered to the setting point (or below) of the gelling agent. Preferably, the gelling agent is hydrated in warm aqueous solution prior to being combined with the medicament. More preferably, the gelling agent in aqueous solution is heated to above 40°C and then added to the medicament, optionally in aqueous solution, and the combined solution cooled to the setting point of the gelling agent.

When gelatin is selected as the gelling agent, an aqueous solution of gelatin in the range of approximately 40°C to 100°C may be added to the medicament, optionally in aqueous solution. Water in the range of approximately 40°C - 100°C may also be added to a combination of the medicament and gelling agent. Preferably, a gelatinous composition will form within 30 to 120 minutes of combining the gelling agent with the medicament followed by storing the mixture at or below room temperature, preferably below 10°C.

The composition may further include one or more optional additives such as preservatives, carriers and colouring agents. The composition may. for instance, include preservatives such as methyl paraben and propyl paraben or mixtures thereof. Other preservatives suitable for oral administration may also be used. Preferably, the preservatives are in a concentration of 0.001 to 0.5% w/v.

The composition may also include a carrier, such as propylene glycol, to aid dispersion of the medicament. Other carriers suitable for oral administration may also be used. Preferably, the carrier is present in a concentration of at least 0.10% w/v. more preferably at least 0.90% w/v.

It will be appreciated that other ingredients may be included in the final gelatinous composition. Colouring agents may be included in the method so that a coloured jelly-like substance is obtained. It has been found that the formation of a coloured jelly makes the administration of the medicament more attractive and palatable to younger children by virtue of the fact that the consumption of jelly is associated with a sweet or a dessert. It will be appreciated that for certain medicaments such as rehydrating mixtures, additional ingredients such as sugar may not be desirable due to the fact that they tend to increase the osmolality of the medicament thereby causing further complications, such as. increasing diarrhoea in a patient.

The orally-administrable preparation according to the second aspect of the invention is hydrated to form the gelatinous composition prior to administration to a patient. The orally-administrable preparation prior to hvdration may be a powder, liquid or a mixture of powders and liquids depending on the physical state of the gelling agent and medicament(s) used.

In a preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises gelatin and a rehydrating mixture including essential salts, wherein the gelatinous composition has improved palatability relative to the rehydrating mixture alone.

In another preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises gelatin and an antihistamine. wherein the gelatinous composition has improved palatability relative to the antihistamine alone. In another preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises gelatin and an analgesic preparation, wherein the gelatinous composition has improved palatability relative to the analgesic preparation alone.

In another preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises gelatin and an antibiotic preparation, wherein the gelatinous composition has improved palatability relative to the antibiotic preparation alone.

In another preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises xanthan and a rehydrating mixture, wherein the gelatinous composition has improved palatability relative to the rehydrating mixture alone.

In a further preferred embodiment according to the first aspect of the invention, the orally administrable gelatinous composition comprises xanthan and an analgesic preparation, wherein the gelatinous composition has improved palatability relative to the analgesic preparation alone. In a piefened embodiment according to the second aspect of the invention, the oially admimstiable piepaiation comprises gelatin and a lehydiatmg mixtuie including essential salts wheiem when the pieparation is hvdiated a gelatinous composition is foimed which is impioved in palatabihU lelative to the lehvdiating mixtuie alone

In anothei piefened embodiment accoidmg to the second aspect of the invention the oially admimstiable preparation comprises gelatin and an analgesic piepaiation. wherein when the orally-administrable preparation is hydrated a gelatinous composition is foimed which is improved in palatability lelative to the analgesic prepaiation alone

In anothei piefened embodiment accoidmg to the second aspect of the invention the oially admimstiable piepaiation compnses gelatin and an antihistamine piepaiation wheiem when the orally-administrable preparation is hydiated a gelatinous composition is formed which is improved in palatability lelative to the antihistamine preparation alone

In another prefeπed embodiment according to the second aspect of the invention, the oially admimstiable preparation comprises gelatin and an antibiotic preparation, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability lelative to the antibiotic pieparation alone

In anothei preferred embodiment accoidmg to the second aspect of the invention, the orally admimstiable preparation comprises xanthan and an analgesic piepaiation wheiem when the oially-admmistrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the analgesic preparation alone

In a further prefeπed embodiment according to the second aspect of the invention, the orally administrable preparation comprises xanthan and a rehydration mixtuie. wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability lelative to the lehydiatmg mixture alone

In a preferred embodiment according to a fourth aspect of the invention, the method of improving the palatability of an orally admimstrable rehydration mixture including essential salts with unpalatable characteristics, comprises combining the rehydration mixture with gelatin in an aqueous solution to form a gelatinous composition which is improved in palatability relative to an aqueous solution of the lehydration mixture alone Throughout this specification, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

In order that the present invention may be more clearly understood, preferred forms will be described with reference to the following examples. Vlodes for Carrying Out the Invention

Examples 1 to 3 describe compositions and methods of improving the palatability of an orally administrable medicament by the formation of a gelatinous composition. The palatability of the gelatinous composition with respect to the standard medicament is assessed in terms of taste and odour.

Examples 4 and 5 describe the concentration of xanthan gum required to form a gelatinous composition according to the invention when combined with paracetamol and Gastrolyte® respectively.

Example 6 demonstrates the palatability of the gelatinous compositions according to the present invention when compared with the medicament alone as assessed by 3 subjects.

Example 1 - A method of improving the palatability of Gastrolyte® Gelatin (4 g) and Gastrolyte® (1 sachet. 4.9 g. Commercially available from Rhone-Poulenc Rorer Australia Pty Ltd) were dissolved in water (200 iriL) at approximately 50°C. The solution was mixed well and stored at approximately 18°C. After approximately 90 minutes, the solution set into a gelatinous composition with elastic texture. Gastrolyte®. sold by Rhone-Poulenc Rorer Australia Pty Ltd. is described by MIMS Annual 1995 (19-933) as having the following particulars:

Composition: Compound sodium chloride and glucose oral powder.

Sαciϊe-s-sodium chloride 470 mg. potassium chloride 300 mg. sodium acid citrate 530 mg, glucose 3.56 g. TαWete-sodium chloride 117 mg. potassium chloride 186 mg, anhydrous cirtic acid 384 mg. glucose 1.62g.

Desciption: Sachet-ΪL of made-up solution (5 sachets. 5 x 200 mL quantities) contains sodium (Na⁺) 60 mmol. potassium (K⁺) 20 mmol, chloride (CI^") 60 mmol. citrate 10 mmol and glucose 90 mmol. Tablets-lL of made-up solution (10 tablets. 5 x 200 mL quantities) contains (Na⁺) 60 mmol. K^~ 25 mmol. CI^" 45 mmol. citrate 20 mmol and glucose 90 mmol.

Total osmolarity is 240mmol/L. Indications: Oral correction of fluid and electrolyte loss in infants. children and adults. The product formulated to treat fluid and electrolyte loss asscoiated with acute dehydration in infantile diarrhoea, but is also appropriate for the treatment of older children and adults. The resulting gelatinous Gastrolyte® composition was compared with a standard solution of Gastrolyte® (1 sachet. 4.9g) in cold water (200 mL). The standard Gastrolyte® solution was found to be salty in taste and unpleasant in odour, however, it was surprisingly found that the gelatinous Gastrolyte® composition was substantially devoid of these adverse characteristics.

The gelatinous Gastrolyte® composition was found to be more palatable than the non-gelatinous form for two reasons: i) the taste and odour of the Gastrolyte® were masked: and ii) the jelly form was a more desirable medium to consume. Example 2: A method of improving the palatability of Panadol® elixir

In a similar manner as described in Example 1. a gelatinous Panadol® elixir composition was prepared by combining gelatin (0.5g) dissolved in water (5mL) at approximately 50°C and Panadol® elixir (10 mL, Commercially available from Sterling Health). A gelatinous composition formed after approximately 40 minutes.

Oral administration of the final gelatinous composition was found to be more palatable than the original Panadol® elixir solution with the unpleasant taste of the Panadol® elixir being absent in the gelatinous Panadol® elixir composition. Example 3: A method of improving the palatability of promethazine

In a similar manner as described in Example 1, a gelatinous promethazine composition was prepared by combining gelatin (0.5 g) dissolved in water (5mL) at approximately 50°C and promethazine syrup (10 mL. Commercially available from Rhone-Poulenc Rorer Australia Pty Ltd.). A gelatinous composition formed after approximately 40 minutes. Oral administration of the final gelatinous composition was found to be more palatable than the original promethazine syrup with the unpleasant taste of the promethazine syrup being absent in the gelatinous promethazine composition.

Example 4: Gelatinous compositions prepared from xanthan gum and paracetamol.

Paracetamol (2.5 g. Commercially available from Smith-Kline Beecham) was combined with xanthan gum in varying concentrations (0%, 0.5%. 1.5% and 3.0% w/v). methyl paraben. propyl paraben. propylene glycol and made up to 100 mL with purified water to produce a range of gelatinous composition according to the present invention.

Table 1 lists the ingredients used to make three gelatinous compositions according to the present invention. Sample 1 is a control that contains no xanthan gum while Samples 2 to 4 contain varying concentrations of xanthan gum that are suitable for forming the gelatinous composition according to the present invention.

Table 1:

Example 5: Gelatinous compositions prepared from xanthan gum and Gastrolyte®.

Gastrolyte® (2.45g. Commercially available from Rhone-Poulenc Rorer Australia Pty Ltd) was combined with xanthan gum in varying concentrations (0%. 0.5%. 1.5% and 3.0% w/v). methyl paraben. propyl paraben. propylene glycol and made up to 100 mL with purified water to produce a range of gelatinous composition according to the present invention.

Table 2 lists the ingredients used to make three gelatinous compositions according to the present invention. Sample 1 is a control that contains no xanthan gum while Samples 2 to 4 contain varying concentrations of xanthan gum that are suitable for forming the gelatinous composition according to the present invention.

Table 2:

Example 6: Palatability of gelatinous compositions according to the present invention.

The palatability of samples of gelatinous compositions of the present invention containing medicaments and gelling agents were compared with the palatability of samples of the medicament by three human adult subjects. The medicaments tested were Gastrolyte®. paracetamol and erythromycin and the gelling agents used include gelatin and xanthan gum. Table 3 lists the ingredients in the samples. Gelatinous compositions were made for Samples Al. A2. Bl. B2 and Cl by combining the relevant medicament (Gastrolyte®. paracetamol or erythromycin) in the amount indicated with a gelling agent in the amount specified.

Table 3:

Table 4 provides the results obtained from the tasting comparison by the three human adult subjects. All three subjects found that the gelatinous compositions according to the present invention (Samples Al. A2, B2. B2 and Cl) were more palatable in terms of flavour saltiness, after-taste and in some cases bitterness and smell over the medicament in its non-gelatinous state.

Table 4:

Ratings:

1 = very weak 5 = very strong x = not tested y ■= smell detected In summary, it has been found that the gelatinous composition containing the medicament according to the present invention is more palatable than the medicament alone for the following reasons:

1) the taste and Or odour of the medicament has been masked: and n) the jelly-like form of the medicament makes oral administration oi the medicament moie appealing, especially when colouring is added

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are. therefore, to be considered in all respects as illustrative and not restrictive

Claims

1. An orally-administrable gelatinous composition comprising a gelling agent and a medicament, wherein the gelatinous composition has improved palatability relative to the medicament alone.

2. The orally-administrable gelatinous composition according to claim 1, wherein the gelling agent has a concentration in the range of 0.05% w/v to

15% w/v.

3. The orally-administrable gelatinous composition according to claim 2. wherein the concentration of gelling agent is 0.25% w/v to 7% w/v.

4. The orally-administrable gelatinous composition according to claim 3, wherein the concentration of gelling agent is 0.5 to 3% w/v.

5. The orally-administrable gelatinous composition according to any one claims 1 to 4. wherein the gelling agent is selected from the group consisting of gelatins, gums, agars. and mixtures thereof.

6. The orally-administrable gelatinous composition according to claim 5, wherein the gelling agent is gelatin, xanthan gum or mixtures thereof.

7. The orally-administrable gelatinous composition according to any one of claims 1 to 6. wherein the medicament comprises rehydration mixtures; analgesic and anti-inflammatory preparations: antibiotics: or antihistamine preparations.

8. An orally-administrable gelatinous composition comprising gelatin and a rehydrating mixture, wherein the gelatinous composition has improved palatability relative to the rehydrating mixture alone.

9. An orally-administrable gelatinous composition comprising gelatin and an antihistamine. wherein the gelatinous composition has improved palatability relative to the antihistamine alone.

10. An orally-administrable gelatinous composition comprising gelatin and an analgesic preparation, wherein the gelatinous composition has improved palatability relative to the analgesic preparation alone.

11. An orally-administrable gelatinous composition comprising gelatin and an antibiotic preparation, wherein the gelatinous composition has improved palatability relative to the antibiotic preparation alone.

12. An orally-administrable gelatinous composition comprising xanthan and a rehydrating mixture, wherein the gelatinous composition has improved palatability relative to the rehydrating mixture alone.

13. An orally-administrable gelatinous composition comprising xanthan and an analgesic preparation, wherein the gelatinous composition has improved palatability relative to the analgesic preparation alone.

14. The orally-administrable gelatinous composition according to any one of claims 1 to 13. wherein the composition further comprises one or more additives selected from the group consisting of preservatives, carriers, and colouring agents.

15. An orally-administrable preparation comprising a gelling agent and a medicament, wherein when the preparation is hydrated a gelatinous composition is formed which has improved palatability relative to the medicament alone.

16. The orally-administrable preparation according to claim 15, wherein when the preparation is hydrated. the gelling agent has a concentration in the range of 0.05% w/v to 15% w/v.

17. The orally-administrable preparation according to claim 16, wherein the concentration of gelling agent is 0.25% w/v to 7% w/v.

18. The orally-administrable preparation according to claim 17, wherein the concentration of gelling agent is 0.5% w/v to 3% w/v.

19. The orally-administrable preparation according to any one of claims 15 to 18 wherein the gelling agent is selected from the group consisting of gelatins, gums, agars. and mixtures thereof.

20. The orally-administrable preparation according to claim 19, wherein the gelling agent is gelatin, xanthan gum or mixtures thereof.

21. The orally-administrable preparation according to any one of claims 15 to 20 wherein the medicament comprises rehydration mixtures; analgesic and anti-inflammatory preparations: antibiotics: or antihistamine preparations.

22. An orally-administrable preparation comprising gelatin and a rehydrating mixture, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the rehydrating mixture alone.

23. An orally-administrable preparation comprising gelatin and an analgesic preparation, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the analgesic preparation alone.

24. An orally-administrable preparation comprising gelatin and an antihistamine preparation, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the antihistamine preparation alone.

25. An orally-administrable preparation comprising gelatin and an antibiotic preparation, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the antibiotic preparation alone.

26. An orally-administrable preparation comprising xanthan and an analgesic preparation, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the analgesic preparation alone.

27. An orally-administrable preparation comprising xanthan and a rehydration mixture, wherein when the orally-administrable preparation is hydrated a gelatinous composition is formed which is improved in palatability relative to the rehydrating mixture alone.

28. The orally-administrable preparation according to any one of claims 15 to 27 wherein the preparation further includes one or more additives selected from the group consisting of preservatives, carriers, and colouring agents.

29. The orally-administrable preparation according to any one of claims 15 to 28 wherein the preparation is hydrated to form the gelatinous composition prior to administration to a patient.

30. A method of forming an orally-administrable gelatinous composition according to any one of claims 1 to 14. the method comprising combining a medicament with a gelling agent in a manner so as to form a gelatinous composition which has improved in palatability relative to the medicament alone.

31. The method according to claim 30. wherein the medicament and gelling agent are combined in a solvent and the temperature of the solvent is raised to allow at least the gelling agent to dissolve and then lowered to form the gelatinous composition.

32. The method according to claim 31 wherein the temperature is raised to 40°C to 100°C.

33. The method according to claim 31 or 3? h r in the solvent is water.

34. Use of a gelling agent in the preparation of an orallv-administrable gelatinous composition for the treatment of a medical condition, wherein the gelling agent is combined with a medicament with unpalatable qualities to form the gelatinous composition which is improved in palatability relative to the medicament alone.