FORM 2 THE PATENTS ACT, 1970 (39 of 1970) AND THE PATENTS RULES, 2003 COMPLETE SPECIFICATION (See Section 10; rule 13) TITLE OF THE INVENTION "SUSTAINED RELEASE COMPOSITIONS COMPRISING GUMS AND SUGAR ALCOHOLS" APPLICANT AVANTOR PERFORMANCE MATERIALS, INC. of 222 Red School Lane, Phillipsburg, New Jersey 08865, USA; Nationality : USA SUSTAINED RELEASE COMPOSITIONS COMPRISING GUMS AND SUGAR ALCOHOLS Background of Invention Sustained release compositions allow administration of an effective dose of a drug over an extended period of time. Sustained release is advantageous since patient's side effects arising out of administering an immediate release therapy may be reduced. Sustained or prolonged-release dosage forms of various drugs are known in the an. Conventional sustained release dosage forms include the use of a polymer matrix as well as complexing the drug with an ion exchange resin forming a drug-ion exchange resin complex particle. After administration, the drug is slowly released from the complex or matrix over time, thereby providing a continuous delivery of drug to the patient. Conventional pharmaceutical sustained release compositions often include polymers such as hydroxylproplyl methytcellulose, sodium carboxy methylcellulose, hydroxy lpropyl cellulose, methyl cellulose, chilosan, and natural gums to sustain drug delivery. Polysaccharide gums, for example guar gum, locust bean gum, xanthan gum, karaya gum, lara gum and Konjac gum are known to be potential bydrophilic matrix carriers for sustained delivery of drugs with varying solubility, In pharmaceutical formulations, guar gum has been used as a binder, disintegranL suspending agent, thickening agent and stabilizing agent as well as a carrier in colon targeting delivers system. It is practically insoluble in organic solvents; in hot or cold water it disperses and swells almost immediately to form a highly viscous thixotropic solution. Viscosity is dependent on temperature, time, concentration, pH, rate of agitation and particle size. Prolonged heating reduces viscosity. Guar gum is found 10 have poor flow properties, poor compressibility and uneven particle size and is to be incorporated in the matrix tablets in large proportion (30 to 90%). and tablets containing guar gum are typically prepared by wet granulation technique. While guar gum is a well accepted pharmaceutical excipienl used in low proportions as a binder, disinlegranl or carrier in conventional dosage forms, it is not a preferred excipient for materials that can be directly compressed. Prior art discloses the use of guar gum in a tricalcium phosphate agglomerate formed by spray drying an aqueous slum' of tricalcium phosphate and a binder which may be guar gum to enable direct compression of a chewable oral dosage form. Guar gum has also been used in a method for stabilizing proteins where an aqueous solution of the protein and an aqueous polysaccharide gum such as guar gum are spray dried or lyophilized and then coaled and encapsulated. Another method utilizing guar gum is a method of making a solid interpoiymer complex for use as a controlled release matrix for oral administration, from a first polymer and one or more second complementary polymers capable of complexing with the first polymer to form the interpoiymer complex, wherein one of the polymers is guar gum and (he process comprises several steps including a step of spray drying to remove the solvent. The prior art also discloses compositions containing heteropolyschaarides such as xanthart gum and locust bean gum, cross-linked along with an inert diluent prepared by a wet granulation process. This method therefore requires the use of two polysaccharide gums and a wet granulation process The composition of the present invention is prepared by spray drying. Spray drying is a commonly used, rapid, continuous method of drying a liquid feed through a hot gas that eliminates additional processing for obtaining dry material. It is essentially a three-step drying process consisting of: (I) alomi/ation of a liquid feed into a spray of fine droplets; (2) suspension of droplels by a heated gas stream, evaporation of the liquid; and (3) separation of the dried powder from the gas stream and collection of same. The process of spray drying and other drying processes such as freeze drying are applied widely for obtaining dried products, but there exists no prior art for the application of such processes to improve the properties of polysaccharide gums. Summary of In venlion In an illustrative aspect of the present invention there is provided a sustained release composition comprising substantially spherical particles of at least one polysaccharide gum in combination with at least one polyhydric sugar alcohol. In another illustrative aspect of the present invention there is provided a sustained release composition comprising a spray dried mixture of at least one polysaccharide gum in combination with at least one polyhydric sugar alcohol. In yet another illustrative aspect of the present invention there is provided a method for producing a sustained release composition, the method comprising dissolving at least one polysaccharide gum and at least one polyhydric sugar alcohol in a solvent to form a solution/suspension, and spray drying the solution/suspension to form particles of the sustained release composition. In still another illustrative aspect of the present invention there is provided method of making a sustained release pharmaceutical solid dosage form, the method comprising dissolving at least one polysaccharide gum and al least one polyhydric sugar alcohol in a solvent to form a solution/suspension; spray drying the solution/suspension to form particles of a sustained release composition: mixing the sustained release composition with at least one filler and at least one active pharmaceutical ingredient to form a labletling mixture; and compressing the labletling mixture to form the sustained release pharmaceutical dosage form. In a further illustrative aspect of (he present invention there is provided a sustained release pharmaceutical solid dosage form comprising a spray dried mixture of at least one polysaccharide gum in combination with at least one polyhydric sugar alcohol; a! least one filler; and at least one active pharmaceutical ingredient. In another illustrative aspect of the present invention there is provided a sustained release composition comprising a spray dried mixture of at least one polysaccharide gum in combination with at least one oligosaccharide. In yet another illustrative aspect of the present invention ihere is provided a method for producing a sustained release composition, the method comprising mixing at least one polysaccharide gum and at least one oligosaccharide in a solvent to form a solution/suspension, and spray drying the solution/suspension to form panicles of the sustained release composition. A solid dosage form may be produced from these particles by mixing the sustained release composition with at least one filler and at least on active pharmaceutical ingredient to form a tabletling mixture, and compressing the tab-letting mixture to form the sustained release pharmaceutical dosage form. In still.another illustrative aspect of the present invention there is provided a sustained release pharmaceutical solid dosage form comprising a spray dried mixture of at least one polysaccharide gum in combination with at least one oligosaccharide; at least one filler; and at least one active pharmaceutical ingredient. In a further illustrative aspect of the present invention there is provided a sustained release composition comprising a spray dried mixture of at least one polysaccharide gum in combination wiih at least one polyhydric sugar alcohol and at least one oligosaccharide. . Brief Description of Drawings Figure I is an illustration of SEM micrographs of guar gum. Figure 2 is an illustration of SEM micrographs of mannilol (Pearlitol 160 C -Roquette). Figure 3 is an illustration of SEM micrographs of spray dried guar gum/mannitol, 1:1 according to Example 1. Figure 4 is an illustration of SEM micrographs of spray-cried guar gum/mannitol, 1:4 according to Example 14. Figure 5 is an illustration of an SEM micrograph of locusl bean gum (cold water soluble). Figure 6 is an illustration of SEM micrographs of locust bean gum (cold water soluble): mannitol. 1:1, according to Example 15. Figure 7 is an illustration of SEM micrographs of inulin (Orafli ST Gel). Figure 8 is an illustration of SEM micrographs of spray dried guar gum/inulin according to Example 16. Figure 0 is a dissolution profile of diclofenac sodium formulations F1-F4 according to Example 6. Figure 10 is a dissolution profile of diclofenac sodium formulations F5-F7 and the marketed drug, Voveran SR. according to Example 6. Figure 11 is a dissolution profile of Venlafaxine HCL according to Example 7. Figure 12 is a dissolution profile of Guaifenesine Tablets according to Example 8. Figure 13 is a dissolution profile of tramadol hydrochloride according to Example 9. Figure 14 is a dissolution profile of diclofenac sodium formulations according lo Example 10, through 24 hours. Figure 15 is a dissolution profile of diclofenac sodium formulations according to Example 10, through 8 hours. Figure 16 is a dissolution profile of acetaminophen formulations according to Example 11. Detailed Description The present invention provides improved sustained release pharmaceutical compositions comprising polysaccharide gums and polyhydric sugar alcohols. More particularly, the invention provides a novel spray dried sustained release composition comprising polysaccharides gums such as guar gum, locust bean gum, xanthan gum, karaya gum tara gum or Konjac gum in combination with polyhydric sugar alcohol. The composition provides enhanced flow properties, uniform spherical particle and release retardant properties for the formulation of novel drug delivery7 systems. It has been unexpectedly discovered that a composition produced by spray drying a solution/suspension including at least one polysaccharide gum and a( least one polyhydric sugar alcohol results in a product that provides a sustained release profile when formulated with an API. Physical mixing or wet granulation of polysaccharide gum and polyhydric sugar alcohol component does not provide a composition suitable for sustained release applications, although a limited release retardation may be observed. Polysaccharide gums are either hydrophobic or hydrophilic high molecular weight molecules that produce gels or high viscosity solulions with a low level of the gum present. Suitable polysaccharide gums for the present invention include guar gum, xanthan gum. locust bean gum, karaya gum, lara gum, Konjac gum and mixtures thereof. Guar Gum is obtained from the seed of the legume Cyamopsis tetragonolobus. Guar gum forms a solution/suspension al 1% with a high viscosity of 5600 CPS. The solution/suspension is non- Newtonian and the viscosity changes with temperature., at 85 °C a 1% solution/suspension has a viscosity of about 2500 CPS. Guar gum is more soluble than locust bean gum and is nol selfgelling. Locust bean gum is obtained from the seed of the carcb tree. Locust bean gum forms a solution/suspension at 1% with a viscosity of 3000 CPS. Locust bean gum is only slightly soluble in water and must be healed 10 85 °C to achieve full viscosity. Locust bean gum in not selfgelling. Gum Karaya is exuded from Sterculia urens a large bushy tree. Karaya gum forms a solution/suspension at 1% with a viscosity of 1000 CPS Karaya is one of the least soluble gums and usually forms a uniform dispersion. In accordance with the present invention, sproy drying of solution/suspensions of polysaccharide gum in the range of 0.25%-1.0% of solid content was attempted. The viscosity of the solution/suspensions were in the range of 350-4800 cp. making spray drying of polysaccharide gum solution/suspensions alone impractical, as the polysaccharide gum stuck to the wall of drying chamber. It was surprisingly determined that a combination of polysaccharide gum with a sugar improved the spray characteristics of the polysaccharide gum. The polysaccharide gum was combined in various proportions with at least one polyhydric sugar alcohol selected from mannitol, xylitol. maltitol, lactitol, sorbitol, erythrito), isomalt and mixtures thereof. The combination reduced the viscosity of the polysaccharide gum adequately to result in excellent spray characteristics and ease in spray drying, resulting in spray dried polysaccharide, In the illustrative examples given herein, the polysaccharide gum and polyhydric sugar gum were physically mixed prior to adding a liquid to form a solution/suspension. However, it is noted that this step is not required, and further that it is not required that the components be mixed together in any particular order. In an illustrative, non-limiting embodiment, the polysaccharide gum: polyhydric sugar alcohol ratio is typically about 1:0.5 to 1:10, with a presently preferred ratio ofaboul 1: 1 to 1:3. The polyhydric sugar alcohols being non-hygroscopic, they were combined effectively with moisture sensitive ingredients as well. Further,the polyhydric sugar alcohol prevented thickening or the aqueous dispersion and also increased the hydrophobic ty or the polysaccharide gum/polyhydric sugar alcohol material. Most surprisingly, the co-processed, spray dried forms of ihe polysaccharide gum/ polyhydric sugar alcohol of the instant invention are suitable Tor direct compression, and result in a sustained release solid dosage form. In an alternate embodiment, the spray dried particles may be a preferred excipient for wet granulation as well. The spray drying processesused ore conventional processes known in the art. In one illustrative embodiment, the polysaccharide gum and polyhydric sugar alcohol solution/suspension was sprayed into spray drier at a feed rale of 45-150 ml/hour. The inlet and outlel temperatures varied from 100-220° and G0-125°C respeclively. The atomizing air pressure varied from 1 -4 bars, the compressed air flow was 45-85% and vacuum was 70-300 mm. The process yield varied from 20-60%. Examples 1 and 10 are non-limiting illustration of the production of guar gum/mannitol spray dried particles of Ihe present invention. As clearly shown in Example 10, Ihe spray dried polysaccharide gum/polyhydric sugar alcohol particles of the present invention produce an exceptional sustained release dissolution profile, as compared to the dissolution profile of tablets produced from polysaccharide gum and polyhydric sugar alcohol that were merely physically mixed. The powder morphology, the shape and surface topography of plain guar gum, mannitol, and the spray dried polysaccharide gum/polyhydric sugar alcohol particles, were observed by scanning electron microscopy (SEM). SEM micrographs of guar gum, shown in Figure I showed its polygonal shape with porous surface, white SEM of mannitol. shown in Figure 2 showed smooth surface without any porous structure. It is noted the term 'plain" defines commercially available composition prior to spray drying. The spray dried particles of guar gum with mannitol were evaluated for powder morphology, powder characteristics and possible interactions beiween gums and sugars and exemplified herein. The spray dried polysaccharide gum/polyhydric sugar alcohol particles were found to be spherical, with smaller particle size than gum as such with favorable angle of repose and Carr,'s index. The spray dried polysaccharide gum/polyhydric sugar alcohol particles were substantially spherical in shape wilh rough surface without any porous structure and were free flowing, as shown in Figures 3 and 4, according lo Examples 1 and 14, respectively.. DSC and FTIR analysis of the starting materials, guar gum and mannitol, as well as particles of a physical mixture of guar gum and mannitol, and spray dried polysaccharide gum/polyhydric sugar alcohol particles according lo Example I revealed no reaction between the starling materials, and also showed loss of bound form of water present in guar gum. (See Examples 4 and 5.) The spray dried panicles of the inslanl invention were used lo formulate drug dosage forms The spray dried particles were further formulated as release relardant agents in novel drug delivery systems as exemplified herein. Sustained release dosage forms utilizing the spray dried polysaccharide gum/polyhydric sugar alcohol particles were prepared with both highly soluble active pharmaceutical ingredients (API), such as tramadol hydrochloride (Example 9) and venlafaxine hydrochloride (Example 7) and sparingly soluble API such as guaiphenesin (Example 8) and diclofenac sodium (Examples 6 and 10.) II has therefore been clearly illustrated that the spray dried particles of the present invention are suitable for a wide variety of API. Typically, the sustained release formulation of the present invention will be mixed wilh a filler and the API prior to compression lo produce the solid dosage form. Selection of a filler compatible with the specific API, as is well known in the art, places little if any limitation on the number and types of API which can be utilized with the present invention. Suitable fillers for use with the present invention are well known in the art, and include but are not limited to microcry stall ine cellulose (MCC), lactose, dicalcium phosphate and mixtures thereof. In an alternate embodiment, the spray dried panicles of the present invention may be mixed with a conventional filler, for example hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), starch and mixtures thereof, and at least one API for wet granulation. The dosage forms were formulated with the spray dried particles ranging from 5% to 60% of the formulation The higher percentages of the spray dried particles were for drugs that have more solubility whereas the spray dried compressed material was exercised in lower quantities in drugs with poor solubility. But the release profiles of the drugs were sustained with the co-processed material of polysaccharide and sugar of the instant invention, independent of the solubility of the drug. Additional ingredients in the formulations, such as pharmaceutically acceptable excipients including filler and lubricants, may be utilized with the present invention as is well known in the art. The tablets were evaluated for physical parameters and the dissolution profile and compared with that of marketed formulations and formulation prepared with conventionally accepted release retardants. The processing of the polysaccharide gum in accordance with the invention made it more flowable, spherical, and uniform in particle size and most importantly imparted release retardant properties as exemplified herein. This provided a ready-to-use, simple sustained release excipienl with wide ranging applications in formulation development without the disadvantages of batch-to-batch non-uniformity found in naturally sourced excipients. Further, newly synthesized polymers need to be approved by regulatory authorities before being available for use. The polysaccharides of the invention being well accepted excipients are only undergoing a process of spray drying and this does not change their regulatory status as pharmaceutical!} accepted excipients and are generally regarded as safe with practically no adverse reports. The spray dried panicles of the present invention find application in conventional dosage forms such as tablets, capsules and granules. These particles are especially well suited for use as sustained release, extended release or delayed release, colon targeted and gaslro retenlive dosage forms. In an alternate embodiment the sustained release composition can also be made by spray drying a polysaccharide gum and a mixture of oligo- and poly-saccharides which are composed of fructose units linked together by (3( 1-2) linkages. Almost every molecule of the mixture of oligo- and poly-saccharides which are composed of fructose units linked together by p(l-2) linkages is terminated by a glucose unit. The total number of fruciose and glucose units (degree of polymerization) of the oligo- and polysaccharide which are composed of fructose unils linked together by p(1 -2) linkages ranges mainly between 3 to 60. A relevant example of the class of materials that are composed of a mixture of oligo- and poly fruciose as described above is chicory inulin. We have surprisingly discovered that combining a polysaccharide gum and chicory inulin in solution/dispersion allows the easy spray drying of a polysaccharide gum, and that the resulting spray dried polysaccharide gum/inulin material has the property of retardation of drug release. Inulin (also known as oligofructose. polyfructose) is a naturally occurring polysaccharide consisting of a linear chain of linked D-fruclose molecules having one terminal glucose molecule of the general formula: C6H11O4(C6H11O)mOH. with a molecular weight of up to 5000. Grades of inulin that are obtained by partial enzymatic hydrolysis of ''chicory inulin," consisting of oligofructose with a degree of polymerization between 2 and 8 are also suitable for the present invention. SEM micrographs of plain inulin and spray dried inulin/guar gum according to Example 16 are shown in figures 7 and 8 respectively. In another alternate embodiment of the present invention 'he at feast one polysaccharide gum may be mixed with a combination of at least one polyhydric sugar alcohol and at least one oligosaccharide in a solvent to form a spray dryable solution/suspension. The resulting spray dried particles provide an improved sustained release material. The polysaccharide gum/polyhydric sugar alcohol/oligosaccharide spray dried particles are suitable for use in the methods and dosage forms discussed herein relating to the polysaccharide gum/polyhydric sugar alcohol spray dried particles. The following Examples are provided for illustrative purposes only and are not limiting of the present invention disclosed and claimed herein, Example I Preparation of spray dried particles: Spray drying of a solution/suspension of mannilol with guar gum was performed using a spray doer. Spray dried material 1 was guar gum:mannilol in the ratio of 1:1 and spray dried material 2 was guar gum:mannitol in the ratio of 1:2. The solution/suspension was fed through the nozzle (diameter 0.7mm) at the top of the drying chamber ofspray dryer by means of peristaltic pump. The spray dryer operated in co-current airflow. The feed rale varied between 50-200 ml/hr, at an inlet drying temperature of 100-150 °C and outlet drying temperature of 60-100°C. The atomizing air pressure was 1-3 bar and compressed air floiv varied between 60-300 mmWc. The spray dried particles were collected in a reservoir attached to cyclone, cooled down to room temperature, sieved and stored in sealed vials. Example 2 The powder morphology, the shape and surface topography of plain guar gum, plain mannitol, and the spray dried material according.lo Example 1, were observed by scanning electron microscopy (SEM), shown in Figures 1, 2 and 3 respectively. SEM micrographs of guar gum showed its polygonal shape with porous surface, while manniiol showed smooth surface without any porous structure. Spray dried materials were almost spherical in shape with rough surface without any porous structure and was free flowing. Example 3 The powder characteristics such as angle of repose were determined by fixed funnel and standing cone method. Bulk density and true density, and Carrs index were also determined. Table 1 Powder characteristics Guar Gum Spray dried material 1 Spray dried material 2 Shape Irregular Spherical Spherical Size distribution, urn 30-100 1-20 1-20 Angle of Repose 45 22.27 27.34 Example 4 The possibility of any interaction between guar gum and mannitol during spray drying, and between spray dried material and drug was assessed by earning out thermal analysis on plain guar gum, plain mannitol, physical mixture of guar gum, spray dried material and tablet matrix blend using DSC. DSC analysis reveals that there is no reaction between guar gum and mannitol during spray drying and it also shows loss of bound form of water that was present in guar gum. Example 5 The Fourier transform infrared (FTIR) spectroscopy of plain guar gum, plain . mannitol, physical mixture of guar gum and mannitol, and spray dried material were conducted by scanning in the wavelength range of 400-4000cm''. No change in nature of gum and sugar was observed. Example 6 Tablets of Diclofenac Na were manufactured using different concentrations of the co-processed spray dried material consisting of guar gum and mannitol. Hardness of tablets ranged from 6-7 kg /cm1. Tablets were also prepared by using physical mixture of guar gum as such and mannilol to show the effect of co-processed material on the release of drug from tablet. Tablets were also prepared by using HPMC to compare the release properties of spray dried material with HPMC. Tablets were prepared by blending weighed amount of diclofenac No. and the corresponding excipienls as shown in Table 2. Table 2 Formulation of Diclofenac Na. (Quantity per Tablet in mg) mannitol(l: I), SDGGMN2- spray dried guar gum and mannilol(l :2). PMGGMN I - physical mixture of guar gum and mannitol(1:1), The tablets were evaluaied for typical physical tabletting parameters and for dissolution. The dissolution results are graphically represented herein in Figure 9 and Figure 10. The comparative profile of dissolution of co-processed material of gum with sugar and that of the marketed sustained release tablet, Voveran SR, validates the claim of spray dried polysaccharide as a release retardant material. Formulation containing physical mixture of guar gum and mannitol; and HPMC shows nearly 100 % drug release within one hour {Figure 10, F5 and F6) while tablet comprising co-processed material of instant invention shows sustained release of dmg(up to 100% of drug release in 8 Hrs.)(Figure 9). Dissolution profile of F7 matches with the release profile of Voveran SR (up to 75% of drug release in 8 Hrs.) (Figure 10) Example 7 Tablets of venlafaxine HCL were prepared with physical mixture of guar gum and mannitol; HPMC and co-processed spray dried material, respectively, in the range of about 50% of the tablet weight (Table 3), tested for tabletting parameters and dissolution as represented herein in Figure It. The tablets prepared with co-processed material have sustained the delivery of the drug over 10 hours(F I). Ingredients Quantity per Tablet in mg Fl F2 F3 F4 Drug 84 84 84 84 MCC 102 100 200 200 200 HPM C K 100M - - 336 - SDGGMN 1 100 336 - - PMGGMNI - - - 336 Mg Slearate 3 6 6 6 Talc 6 12 12 12 Total 293 638 638 638 % of Release retardant material 34.12 52.66 52.66 52.66 Hydroxypropylmethylcellulose (1,00,000 cP), SDGGMN I - spray dried guar gum and mannilol(l:l), PMGGMN I-physical mixture of guar gum and mannitot(l: I). Example 8 Tablets of guaifenesin were prepared with physical mixture of guar gum and mannilol; HPMC and co-processed spray dried material, respectively., in the range of about 6-14% of the tablet weight (Table 4), tested for tablelting parameters and dissolution as represented herein in Figure 12. The tablets prepared with co-processed spray dried material have sustained the delivery of the drug over 8 hours (Fl ,F2 and F4). Spray dried malerial added to the Drug granules show that co-processed malerial can be formulated with granules. Ingredients Quantity per Tablet in mg Fl F2 F3 F4 F5 Drug 600 600 600 600 600 MCC 101 80 80 80 80 80 PVP k 30 14 14 14 14 14 HPMC K 100M - - 60 - - SPC K 3MN 1 120 60. - 50 - PMGGMN 1 - - - - 60 Mg Stearate 7 7 7 7 7 Talc 14 14 14 14 14 Total 835 775 775 765 775 % of Release retardant Material 14.37 7.74 7,74 0.53 7.74 Hydroxypropylmethylcellulose (1,00,000 cP), SDGGMN1- spray dried guar gum and manrmol(I:l), PMGGMN I-physical mixture of guargum and mannilo(1.1), PVP K30-Poly vinyl pyrrolidone. Example 9 Tablets of lramodol were prepared wilh physical mixture ofguar gum and mannilol: HPMC and co-processed spray dried material, respectively, in the range of about 52% of the tablet weight (Table 5), tested for tabletting parameters and dissolution as represented herein in 13. The tablets prepared with co-processed material have sustained the delivery of the drug over 8 hours.(F2) comparable to marketed product. Tablet (F4) containing physical mixture released drug within one hour, see Figure 13. Table 5 Formulation of Tramadol HCI Tablets Ingredients Quantity per Tablet in mg Fl F2 F3 F4 Tramadol HCI 100 too 100 100 MCC 102 50 15 50 50 HPMCKIOOM - - too - SPGGMN 1 100 135 - - PMGGMNI - - " 100 Mg Stearale 2.5 2.5 2.5 2.5 Talc 5 5 5 5 Total 257.5 257.5 257.5 257.5 % of release retardant material; 38.91 52.52 38.91 38.91 Hydroxypropylrnethylcellulose {1,00,000 cP), SDGGMN1- spray dried guar gum and mannilol(l:l), PMGGMN 1-physical mixture of guar gum and mannitol( 1:1). Example 10 Preparation of sustained released diclofenac sodium tablets: Spray Drying Guar Gum/Manrntol: The solution/suspension was prepared by mixing 1.5 g mannitol with 1.5 g of guar and then blending with a Turrax homogenker. This produced a 0.5% solution/suspension that would work in the spray drier. A higher concentration of 1% produced a solution/suspension that due to its high viscosity would not work in the spray drier system due to clogging of the nozzle. The air nozzle was used on the spray drier. The dryer was run at a 195 °C inlet temperature, with a pump rate of 3 ml/min and an air flow at 65 n/m2. This gave a light yellow colored powder. This powder was then used in sustained release studies using diclofenac at a 16% loading level. The guar/mannitol spray dried material 0.5 g, was combined with 1.0 gofRan QMCC, and 1.0 g of diclofenac sodium. Thelablets were pressed out a 3000 lb, at 500 mg each. Additionally; a similar mechanical blend was produced with 0.25 g guar gum. 0.25g of manniiol. 1.0 g of Ran Q MCC, and 1.0 g of diclofenac sodium. Below in Table 8 are the detailed studies crried out with the diclofenac sodium tablets containing the sustained release spray- dried material, shown in Figures 14 and 15. Method 1: Dissolution medium: pH 6.8 Na phosphate buffer; 900 mL; 37 ± 0.5 'C - Apparatus II (paddle): 50 rpm Samples were withdrawn at each hour for B hours and then at 24 hours. The amount of Diclofenac Na released was determined from the UV absorbance's at the wavelength of maximum absorbance at 276 nm on filtered portions of the solution/suspension under test in comparison with a standard solution/suspension prepared as recommended in the USP method for Diclofenac Sodium delayed-release tablets, buffer stage. Method Il:(adaptalion of the USP method for Diclofenac Sodium delayed-release tablets) Acid stage Dissolution medium: 0.1N HCI; 900 mL; 37 ± 0.5 *C Apparatus If (paddle): 50 rpm After I hour the HCI 0.1 N was decanted from the dissolution vessel and the remaining of the tablet was subjected to the buffer stage (see below). To the 0. IN HCI resulted from the dissolution were added 20 mL of NaOH 5N. The amount of Diclofenac Na released was determined from the UV absorbance at the wavelength of maximum absorbance at 276 nm on filtered portions of lhe solution/suspension under test in comparison with a standard solution/suspension prepared as recommended in the USP method for Diclofenac Sodium delayed-release tablets, acid stage. Buffer Stage Dissolution medium: pH 6.8 Na phosphate buffer; 900 mL; 37 ± 0.5 'C Apparatus II (paddle): 50 rpm Samples were withdrawn at each hour for 7 hours and then at 24 hours. The amount of Diclofenac Na released was determined from the UV absorbance at the wavelength of maximum absorbance at 276 nm on filtered portions of lhe solution/suspension under test in comparison with a standard solution/suspension prepared as recommended in the USP method for Diclofenac Sodium delayed-release tablets, buffer stage. Table 6 Formulation A (using sprav dried ouar-num/mannitol) Ingredient Amount/batch (mg) % Amount/tablet (mg) Diclofenac Na 2000 43.48 217.4 Sprav dried guar.num/mannilol 600 13.04 65.2 Microcryslalline cellulose 2000 43.48 217.4 Total 4600 100 500 Ingredient Amount/balch (mg) % Amount/tablet (mg) Diclofenac Na 2000 43.48 217.4 Guar Gum 300 6.52 32.60 Mannitol 300 6.52 32.60 Microcrysialline cellulose 2000 43.48 217.4 Total 4600 100 600 Wet Granulation of Guar/Mannitol Guar gum 60 g, Manntiol 60 g, and water 25 g were wel granulated using the following conditions, low impeller 870 rpm, low chopper 1000 rpm, dry blending time 2 minutes, high impeller 700 rpm, high chopper 1500 rpm, water addition 16 rpm, wet massing lime 1 min, dried to 3% LOD. This wet granulated material was used to produce test tablets pressed out of with acetaminophen at 16% loading. 500 mg of guar/mannitol, 1.2 g of RanQ MCC, and 0.320 g acetaminophen Compact PVC. Tablets of 500 mg were pressed at 3000 lb. These tablets were found to be unsuitable for a sustained release study since the tablets disintegrated in the medium in less than 30 seconds. The tablets that were produced from the sprayed dried material remained intact for over 24 hours. Comparison of the tablets of Example 10 and 11 are given in Table 8. Table 8 RESULTS Sample Name Time