The present disclosure relates to method to prepare and optimize formulations of mucoadhesive buccal patches of Sumatriptan using SA and carbapol as the base matrix.

BACKGROUND

[002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[003] Buccal route of drug delivery is a best routes among the various routes of drug delivery. Buccal drug delivery is most advantageous because of its abundant blood supply in buccal mucosa, bypassing the hepatic first pass effect and accessibility. However, peroral administration of drugs has disadvantages such as hepatic first pass metabolism and enzymatic degradation within the GI tract, that prohibit oral administration of certain classes of drugs especially peptides and proteins. Consequently, other absorptive mucosae are considered as potential sites for drug administration. Oral cavity has been investigated for number of applications including the treatment of periodontal disease bacterial and fungal infection, aphthous and dental stomatitis. Over the last two decades mucoadhesion has become of interest for its systemic delivery by retaining a formulation intimate contact with buccal cavity. The term bio adhesion has been used to define the attachment of a synthetic natural macromolecule to a biological tissue for an extended period of time. When a substrate is a mucosal system adheres and interacts primarily with the mucus layer, this phenomenon being referred to as mucoadhesion. The adhesive properties of such drug delivery platforms can reduce the enzymatic degradation due to the increased intimacy between the delivery vehicle and the absorbing membrane. The use of mucoadhesive polymers in buccal drug delivery has a greater application. Various mucoadhesive devices, including tablets, films, patches, disks, strips, ointments, and gels, have recently been developed. However, buccal patch offers greater flexibility and comfort than the other devices. In addition, a patch can circumvent the problem of the relatively short residence time of oral gels on mucosa since the gels are easily washed away by saliva. Buccal route of drug delivery provides the direct access to the systemic circulation through the jugular vein bypassing the first pass hepatic metabolism leading to high bioavailability.

Limited absorption area- the total surface area of the membranes of the oral cavity available for drug absorption is 170 cm2 of which ~50 cm2 represents non-keratinized tissues, including buccal membrane.

The barriers such as saliva,mucus,membrane coating granules, basement membrane etc retard the rate and extent of drug absorption through the buccal mucosa. Continuous secretion of the saliva(0.5-2 l/day)leads to subsequent dilution of the drug. The hazard of choking by involuntarily swallowing the delivery system is a concern. Swallowing of saliva can also potentially lead to the loss of dissolved or suspended drug and ultimately the involuntary removal of the dosage form.

[004] Shalini Mishra, G. Kumar, P. Kothiyal,- Buccal drug delivery leads direct access to the systemic circulation through the internal jugular vein bypasses drugs from the hepatic first pass metabolism leading to high bioavailability. Buccal route is an attractive route of administration for systemic drug delivery. Buccal bioadhesive films, releasing topical drugs in the oral cavity at a slow and predetermined rate, provide distinct advantages over traditional dosage forms for treatment of many diseases. This article aims to review the recent developments in the buccal adhesive drug delivery systems to provide basic principles to the young scientists, which will be useful to circumvent the difficulties associated with the formulation design.

[005] Farheen Fiza et. al., Drugs that are administered via the buccal mucosa directly enter the systemic circulation, thereby avoiding hepatic first-pass metabolism. Therefore, this administration route is useful for improving the bioavailability of drugs that are subject to an extensive first-pass effect when delivered orally. For the oral mucosal route of drug administration, various types of dosage forms can be prepared. A sublingual tablet can afford rapid drug absorption and a prompt pharmacological effect; however, the duration of delivery is short owing to the inevitable loss of a large proportion of the administered dose due to swallowing. To avoid such losses, a patch can be formulated that is located on the buccal mucosa of the oral cavity. However, this approach is limited by the thicker dimensions of the buccal membrane compared to the others that line the oral cavity, and constraints impelled by the delivery system itself (the amount of drug reaching the systemic circulation is limited by the area of the mucosa that the patch covers, which, for patient comfort reasons, is relatively small). Direct access to the systemic circulation through the internal jugular vein bypasses drugs from the hepatic first pass metabolism leading to high bioavailability.
[006] Sanket Sharma, R. Yogananda, Buccal administration of drug provides a convenient route of administration for both systemic and local drug actions. The preferred site for retentive oral transmucosal delivery systems and for sustained and controlled release delivery device is the buccal mucosa. Rapid developments in the field of molecular biology and gene technology resulted in generation of many macromolecular drugs including peptides, proteins, polysaccharides, and nucleic acids in great number possessing superior pharmacological efficacy with site specificity and devoid of untoward and toxic effects. However, the main impediment for the oral delivery of such drugs as potential therapeutic agents is their extensive pre-systemic metabolism, instability in acidic environment resulting into inadequate and erratic oral absorption. Direct access to the systemic circulation through the internal jugular vein bypasses drug from the hepatic first pass metabolism leading to high bioavailability. The objective of this article is to review the developments in buccal adhesive drug delivery system as patches.

[007] N.Vidyasagar et. al, this review article is to describe the buccal drug delivery system of different dosage forms such as patches (films) and general considerations in formulation, types of buccal drug delivery dosage forms and describing different categories of drugs and their applications.

[008] Nishan N. Bobade et. al, In this paper main focus on oral mucosa, pathway, barriers to penetration of drug, different dosage forms, evaluation methods; this will be useful to circumvent the difficulties associated with the formulation design.

[009] Pradeep Kumar et. al, this article aims to review the recent developments in the buccal adhesive drug delivery systems to provide basic principles to the young scientists, which will be useful to circumvent the difficulties associated with the formulation design.

[0010] Kinesh V. Patel et. al, this article reviews status of various buccal bioadhesive dosage forms such as tablets, patches, hydrogels and chewing gums and describes the strategies to improve permeation of drugs through the Buccal mucosa. Recent innovations in the dosage form development and in vivo and in vitro mucoadhesion testing methods has also been focused. Lastly, different dissolution testing methods for buccoadhesive dosage forms developed by different researchers have also been discussed.

[0011] Navneet Verma et al, Mucoadhesive Buccal patches of metoprolol Succinate were prepared by solvent casting method using chitosan, polyvinyl alcohol (PVA) and hydroxyethyl cellulose (HEC). Mucoadhesive properties and swelling index were determined for both plain and drug loaded patches. The results showed a remarkable increased in radial swelling after addition of drug to the plain patches. A decrease in the residence time was observed for PVA and Chitosan patches. A considerable decrease in release was observed for chitosan patches after the addition of water-soluble excipient polyvinyl pyrrolidone (PVP). The in-vivo studies carried out on rabbits and evaluate % inhibition of Isoprenaline induced tachycardia. Ageing was done on the patches and the results showed there was no influence on the chemical stability of metoprolol, as reflected from the drug content result. Physical characteristics of the studied patches showed an increase in the residence time with storage accompanied with a decrease in drug release.

[001] Shailaja T et al, Tamarind seed polysaccharide (TS) is derived from the kernel powder of seeds of Tamarindus indica linn. TS has various pharmaceutical applications; however, its application is limited due to uncontrolled rate of hydration, drop in viscosity on storage and susceptibility to microbial contamination. Keeping this in view an attempt was made to overcome some of the disadvantages by suitably grafting the TS with methyl methacrylate (MMA). Chemical method of grafting by potassium per sulphate and ascorbic acid redox pair was selected for grafting. Taguchi L9 design was applied to optimize the grafting process. The grafted product was subjected to physical, chemical and spectral analysis. The physical characterization reveals no drop of viscosity on storage, controlled rate of hydration of Grafted tamarind seed polysaccharide (GTS). The chemical and spectral characterization confirmed the grafting procedure. Metoprolol succinate a low bioavailable (40-50%) drug was selected for the present study and buccal patches were formulated using TS and GTS as polymers. Central composite design was applied to find out the relationship between percentage of TS/GTS and drug release characteristics and to optimize buccal patches with 12-hour drug release. The 2% of TS and 2.86% of GTS buccal patches were able to show a sustain drug release for 12 hours. Invitro, ex vivo drug release studies, release physical parameter studies for all optimized patch formulations reflect the ideal characteristics of buccal patch for delivery of metoprolol succinate.

[002] Drug: Sumatriptan. Sumatriptan is a medication used for the treatment of migraine headaches. It is a synthetic drug belonging to the triptan class. Structurally, it is an analog of the naturally occurring neuro-active alkaloids dimethyltryptamine (DMT), bufotenine, and5-methoxy-dimethyltryptamine, with an N-methyl sulfonamido methyl- group at position C-5 on the indole ring.
[003] Sumatriptan is produced and marketed by various drug manufacturers with many different trade names such as Imitrex, Imigran, and Treximet as a combination product with naproxen. IUPAC Name: 1-[3-(2-Dimethylaminoethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide
Molecular formula: C14H21N3O2S, Molecular weight: 295.402 g/mol. Structure:

Structure of Sumatriptan

[004] Description: A white amorphous solid.
Melting point: 231-240oc
Bioavailability: 15% (oral)/ 96% (s.c).
Half–life: 2.5 hours.
Excretion: 60% urine, 40% feces.
Protein binding: 14–21%.
[005] Sumatriptan is structurally similar to serotonin (5HT) and is a 5-HT receptor (types 5-HT1D and 5-HT1B) agonist. The specific receptor subtypes it activates are present on the cranial arteries and veins. Acting as an agonist at these receptors, sumatriptan reduces the vascular inflammation associated with migraines. Large doses of sumatriptan can cause sulfhemoglobinemia, a rare condition in which the blood changes from red to greenish-black, due to the integration of sulphur into the haemoglobin molecule. If sumatriptan is discontinued, the condition reverses within a few weeks. The most common side-effects reported by at least 2% of patients in controlled trials of sumatriptan (25, 50, and 100 mg tablets) for migraine are atypical sensations (paraesthesia’s and warm/cold sensations) reported by 4% in the placebo group and 5–6% in the sumatriptan groups, pain and other pressure sensations (including chest pain) reported by 4% in the placebo group and 6–8% in the sumatriptan groups, neurological events (vertigo) reported by less than 1% in the placebo group and less than 1% to 2% in the sumatriptan groups.

[006] Therefore, the present disclosure overcomes the above-mentioned problem associated with the traditionally available methods or systems, any of the above-mentioned inventions can be used with the presented disclosed technique with or without modification. The novel method for preparation and evaluation of sumatriptan patches for buccal drug delivery is developed to overcome drawbacks in prior art search. All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies. Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment.

[007] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

OBJECTS OF THE INVENTION

[008] It is an object of the present disclosure is to prepare formulations and systematically evaluate in-vitro diffusion studies of buccal patches of sumatriptan using different polymer and chose the polymer to develop the release of drug in immediate and sustained manner.
[009] Another object of the invention to sumatriptan buccal patches were prepared by solvent casting technique using mercury substrate.
[0010] Yet another further object of the invention different patch formers polymers like sodium (NaCMC), (HEC), HPMC (5cps and 50cps), chitosan and (PVP) were used.
[0011] Yet another further object of the invention the prepared patches will be evaluated for following parameter related to buccal drug delivery system

SUMMARY OF THE INVENTION

[0012] The present disclosure relates to a method to provide develop and optimize formulations of mucoadhesive buccal patches of Sumatriptan using SA and carbapol as the base matrix.
[0013] Sumatriptan is administered in several forms: tablets, subcutaneous injection, and nasal spray. Oral administration (as succinate) suffers from poor bioavailability, partly due to presystemic metabolism some of it gets broken down in the stomach and bloodstream before it reaches the target arteries. There is no simple, direct relationship between sumatriptan concentration (pharmacokinetics) per se in the blood and its anti-migraine effect (pharmacodynamics). This paradox has, to some extent, been resolved by comparing the rates of absorption of the various sumatriptan formulations, rather than the absolute amounts of drug that they deliver. Polymer Profile- Sodium Alginate: Sodium alginate is used to gel in presence of calcium, as shear-thinning thickener in absence of calcium, to stabilize emulsions or foams and to form films. In modernist cuisine, sodium alginate is mostly used with calcium salts to produce small caviar-like and large spheres with liquid inside that burst in the mouth. There are two main processes to create spheres, basic spherification and reverse spherification.

[0014] According to an embodiment the stock solution of sumatriptan consist of 100 mg of Sumatriptan taken in a 100 ml volumetric flask adding 5 ml of methanol and shaking to dissolve the drug with 6.8 PH phosphate buffer solutions.

[0015] In the present disclosure a solution 1 ml is diluted to 10 ml with, 6.8 PH phosphate buffer solutions to give 100 µg /ml concentration. From the above solution 1 ml is diluted to 10 ml with, 6.8 PH phosphate buffer solutions to give 10 µg /ml concentration. The prepared solution i.e., 10 µg/ml concentration was scanned for ?max from 200-400 nm in UV/Visible spectrophotometer.

[0012] In this further system, to undertake solubility study & analytical study of the solubility of Sumatriptan was determined and found very less as78.94 µg/ml in phosphate buffer. The solubility in distilled water was found more than that in phosphate buffer.
[0013] In the present embodiment the FTIR Studies- Drug polymer interactions were studied by FT-IR spectroscopy. One to 2mg of Sumatriptan polymer and physical mixtures of samples were weighed and mixed properly with Potassium bromide to a uniform mixture. A small quantity of the powder was compressed into a thin semi-transparent pellet by applying pressure. The IR spectrum of the pellet from 400-4000cm1 was recorded taking air as the reference and compared to study any interference.

[0014] One should appreciate that although the present disclosure has been explained with respect to a defined Analytical method validation of developed stability indicating method, all of which also completely within the scope of the present disclosure. Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, explain the principles of the present disclosure.
[0016] FIG. 1 illustrates a flowchart for preparation and evaluation of sumatriptan patches for buccal drug delivery
[0017] It should be noted that the figures are not drawn to scale, and the elements of similar structure and functions are generally represented by like reference numerals for illustrative purposes throughout the figures. It should be noted that the figures do not illustrate every aspect of the described embodiments and do not limit the scope of the present disclosure.
[0018] Other objects, advantages, and novel features of the invention will become apparent from the following detailed description of the present embodiment when taken in conjunction with the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

[0019] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details. As the detailed description is concerned various stages are included in embodiments of the present invention, which will be detailed below. The stages can be carried out along with statistical data and by machine-executable instructions, which can be used to direct a general-purpose or special-purpose processor to carry out the procedures. If the specification states a component or feature "may", "can", "could", or "might" be included or have a characteristic, that component or feature is not required to be included or have the characteristic.

[0020] Aspects of the present disclosure relate to method of preparing a transdermal drug delivery system with natural biopolymer matrix It is inferred that the foregoing description is only illustrative of the present invention, and it is not intended that invention be limited or restrictive thereto. Many other specific embodiments of the present invention will be apparent to one skilled in the art from the foregoing disclosure. All substitutions, alterations and modifications of the present invention which comes within the scope of the following claims are to which the present invention is readily susceptible without departing from the spirit of the invention. The scope of the invention should therefore be determined not with reference to appended claims but along with the full scope of equivalents to which such claims are entitled.

[0021] Thus, for example, it will be appreciated by those of ordinary skill in the art that the diagrams, schematics, illustrations, and the like represent conceptual views or processes illustrating systems and method embodying this invention. Those of ordinary skill in the art further understand that the exemplary processes, method, and/or pharmaceutical components described herein are for illustrative purposes and, thus, are not intended to be limited to any named.

[0022] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0023] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

Pre-formulation testing is the first step in the rationale development of dosage forms of a drug. It can be defined as an investigation of physical and chemical properties of drug substance, alone and when in combined with excipients. The overall objective of the pre-formulation testing is to generate information useful to the formulator in developing stable and bio availability dosage forms which can be mass produced.
The goals of pre-formulation studies are:-
• To establish the necessary physicochemical characteristics of a new drug substance.
• To determine its kinetic release rate profile.
• To establish its compatibility with different excipients.
Hence, pre-formulation studies on the obtained sample of drug include colour, taste, solubility analysis, melting point determination and compatibility studies.

[0024] In the given embodiment of the invention Characterization of Sumatriptan
A. Melting point determination: The melting point of Sumatriptan was determined by using melting point apparatus. B. UV spectroscopy.

[0025] According to an embodiment the stock solution of sumatriptan consist of 100 mg of Sumatriptan taken in a 100 ml volumetric flask adding 5 ml of methanol and shaking to dissolve the drug with 6.8 PH phosphate buffer solutions.

[0026] In the above solution 1 ml is diluted to 10 ml with, 6.8 PH phosphate buffer solutions to give 100 µg /ml concentration. From the above solution 1 ml is diluted to 10 ml with, 6.8 PH phosphate buffer solutions to give 10 µg /ml concentration. The prepared solution i.e., 10 µg/ml concentration was scanned for ?max from 200-400 nm in UV/Visible spectrophotometer.

[0027] A saturated solution of TBS was prepared by shaking an excess amount in 2 ml phosphate buffer pH 6.6/distilled water at 25 ± 10°C room temperature for 24 h. The saturated solution was withdrawn, filtered and analyzed at 226 nm using UV visible spectrophotometer (Shimadzu 1601, Japan).

[0028] Drug-excipients interaction study of patches: There is always a possibility of drug-excipients interaction in any formulation due to their intimate contact. The technique employed in this study to know drug-excipients interactions is IR spectroscopy; IR spectroscopy is one of the most powerful analytical techniques which offer the possibility of chemical identification. Infra-red spectra of pure drug Sumatriptan and formulations were scanned by using Jasco FTIR 410, by a thin film method.

[0029] Evaluations of Buccal patch- Uniformity of weight of the patches: Patch size of 1 x 1 cm2 was cut. The weight of each patch was taken, and the weight variation was calculated.

[0030] Thickness uniformity of the patch: The thickness of each patch was measured using thickness tester at different positions of the patch and the average was calculated. Swelling studies of the patches: Weight and area in-crease due to swelling were measured. Buccal patches were left to swell for 1 hour in phosphate buffer of pH 6.8 in a petredish. The patches were tested for the content uniformity. Measurement of Mucoadhesive strength isotonic phosphate buffer pH 6.8 was used as the moistening fluid and time. Folding endurance and Tensile strength of the patch was determined with digital tensile strength tester.

[0031] Kinetic of drug release: the dissolution data were also fitted to well-known Korsmeyer and Peppas semi-empirical model to ascertain the mechanism of drug release. log (Mt/M8) = logk + n logt Where, M8 is the amount of drug release after infinite time; k is the release rate constant which considers structural and geometric characteristics of the buccal patches; and n is the diffusional exponent; indicative of the mechanism of drug release. Table3 shows an analysis of diffusional release mechanism obtained by various value of n. The criteria for selecting the most appropriate model were chosen on the basis of goodness of fit test. The data were processed for regression analysis using MS EXCEL statistical function.

n value Mechanism
n=0.5 Quasi-fickian diffusion
0.5 fickian diffusion
0.5=n=1.0 Anomalous(non-fickian) diffusion
n=1.0 Non –fickian super case II
1 Non –fickian case II
Table no 1: Release Mechanism with Variation of n Values

[0032] In another aspect of the invention Stability studies were conducted as per ICH guidelines. Samples were taken at 30th days intervals for drug content and in-vitro release estimation. The drug content and in-vitro release results were suggesting that there was no significant change in drug content and in-vitro drug release.

FORMULATION OF BUCCAL PATCHES
INGREDIENTS BATCH CODE
F1 F2 F3 F4 F5 F6
SUMATRIPTAN (mg) 10 10 10 10 10 10
SODIUM ALGINATE 225 200 175 150 125 100
CARBOPOL 940P 25 25 25 25 25 25
HPMC 25 - 25 - 25 -
NaCMC 25 25 25 25 25 25
PROPYLENE GLYCOL 4 4 4 4 4 4
DISTILLED WATER 10 10 10 10 10 10

Table no 2: formulation of buccal patches
Formulas for calculation 10 Pathes having 1x1 cm2

A method for preparation and evaluation of sumatriptan patches for buccal drug delivery comprising the steps of:
i. Preparing Stock Solution of Sumatriptan(102)
ii. Preparing formulation of Buccal patches by solvent casting method using different hydrophilic and hydrophobic polymers(104)
iii. Adding polymeric solution 4 mL PG (106) Stirring on a magnetic stirrer for 1 hour at low rpm until homogenous clear solution formed.
iv. Obtaining the homogenous solution from above step and keep it aside till formation of air bubbles free solution and Pouring into a Teflon coated 10x10 mould(108)
v. Drying patches initially at room temperature and then dried for 36 hrs at 60 ºC in a hot air oven(110)
vi. Removing dried patches and checked for any cracks and cutting into 1x1 cm diameter patches using specially fabricated stainless steel patch cutter.(112)
vii. Laminating (114) one side patch with impermeable backing layer (BOPP) and Packing in an aluminium foil and storing in a desiccator for further analysis.

S. NO. CONCENTRATION(µg/ml) ABSORBANCE
1 0 0
2 10 0.2545
3 20 0.4144
4 30 0.5903
5 40 0.7503
6 50 0.906
Table no 3: Standard calibration curve of Sumatriptan
[0033] Calibration curve of Sumatriptan The absorbance values obtained are shown in table 3. Using concentration and absorbance data, a beer and lambert’s plot was obtained.

[0034] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions, or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

[0035] Thus, the scope of the present disclosure is defined by the appended claims and includes both combinations and sub-combinations of the various features described hereinabove as well as variations and modifications thereof, which would occur to persons skilled in the art upon reading the foregoing description.

[0036] ADVANTAGES OF THE INVENTION:-
The Method for preparation and evaluation of sumatriptan patches for buccal drug delivery, the following points can be concluded:
[0037] In the embodiment of the invention the patches prepared were elegant in appearance and smooth surface.
[0038] In the present disclosure the weights of patches were uniform.
[0039] In the present disclosure the thicknesses of patches were uniform.
[0040] In the present disclosure the patches were completely dried.
[0041] In the present disclosure the patches had good flexibility.
[0042] In the present disclosure the patches show uniform swelling index.
[0043] In the present disclosure the surface pH of the patches was uniform.
[0044] In the present disclosure the patches show uniform tensile strength.
[0045] In the present disclosure there was no drug-excipients interaction between the drug and excipients used in the formulation.
[0046] In the present disclosure the drug was distributed throughout the patch uniformly.
[0047] In the present disclosure more than 85 % of the drug was released from all the formulations at the end of 24 hrs.
[0048] In the present disclosure the short-term stability studies indicate there were no significant changes in the drug content and in-vitro drug release for the period of three month.
[0049] In the present disclosure it summarizes that Sumatriptan can be delivered via buccal route.

I/We Claim:

1. A method for preparation (100)and evaluation of sumatriptan patches for buccal drug delivery comprising the steps of:
Preparing Stock Solution of Sumatriptan(102)
Preparing formulation of Buccal patches by solvent casting method using different hydrophilic and hydrophobic polymers(104)
Adding polymeric solution 4 mL PG (106)
Stirring on a magnetic stirrer for 1 hour at low rpm until homogenous clear solution formed.
Obtaining the homogenous solution from above step and keep it aside till formation of air bubbles free solution (108)
Pouring into a Teflon coated 10x10 mould
Drying patches initially at room temperature and then dried for 36 hrs. at 60 ºC in a hot air oven (110)
Removing dried patches and checked for any cracks (112)
Cutting into 1x1 cm diameter patches using specially fabricated stainless steel patch cutter.
Laminating one side patch with impermeable backing layer (BOPP)(114)
Packing in an aluminium foil and storing in a desiccator for further analysis.
2. The method of preparation of a formulation of buccal patches in claim 1, wherein the ingredients consisting of:
sumatriptan (mg) , sodium alginate, carbopol 940p , HPMC , NaCMC and distilled water.
3. The method for preparation and evaluation of sumatriptan patches for buccal drug delivery, as claimed in claim 1 and 2, wherein different F1 to F6 batch code used for formulation of buccal patches.
4. The method for preparation and evaluation of sumatriptan patches for buccal drug delivery, as claimed in claim 1 and 2, wherein the formulas for 10 Pathes having 1x1 cm2.
5. The method for preparation and evaluation of sumatriptan patches for buccal drug delivery, as claimed in claim 1 and 2, wherein the Patch size of 1 x 1 cm2 was cut. The weight of each patch was taken, and the weight variation was calculated.
6. The method for preparation and evaluation of sumatriptan patches for buccal drug delivery, as claimed in claim 1, wherein the stock solution of sumatriptan consist of 100 mg of Sumatriptan taken in a 100 ml volumetric flask adding 5 ml of methanol and shaking to dissolve the drug with 6.8 PH phosphate buffer solutions.
7. The method for preparation and evaluation of sumatriptan patches for buccal drug delivery, as claimed in claim 1 and 6, wherein the prepared solution 10 µg/ml scanned for ?max from 200-400 nm in UV/Visible spectrophotometer