Title of Invention	METHOD FOR IN VITRO DISSOLUTION FOR SUBLINGUAL TABLETS
Abstract	The present invention includes design and development of a suitable in vitro drug release method for sublingual tablets using magnetic stirrer optimized according to the formulation with the following objective namely correlation between in vitro drug release and in vivo dissolution time for the sublingual tablets of drugs of varying solubilities.

Full Text

FORM 2THE PATENT ACT 1970 (39 of 1970) &The Patents Rules, 2003PROVISIONAL SPECIFICATION(See section 10 and rule 13) TITLE OF THE INVENTION: Novel Method For In Vitro Dissolution For Sublingual Tablets 2. APPLICANT Name Nationality Address Mr. Mahesh Vasudeo Abhyankar Indian A.P. Jambhulpada, Taluka Sudhagad, District Raigad,410205 Mr. Pranav Milind Agte Indian C/203, Suresh Smruti, Prathamesh Complex, Veera Desai Road, Andheri West, Mumbai 53 Mr. Prafulla Vilas Beige Indian Flat No. 12, Adishakti Co-op Hsg. Soc. Near Lambe Maruti Mandir, Kansai section, Ambernath East 421501 District Thane Mr. Gaurav J. Tripathi Indian A-303, Vasundhara II, Poonam sagar Complex, Mira Road, east, Thane 401107 Mr. Bhavin Shantilal Dedhia Indian 22, Ramkrishna Niwas, Phadke Road, Dombivli East District Thane 421201. Dr. Mrs. Pradnya Palekar Shanbhag Indian Sarvodaya Garden, 2/704, Pandurangwadi, Shantinagar, Dombivli East District Thane 421201. 3.PREAMBLE TO THE DESCRIPTIONThe following specification particularly describes the invention NOVEL METHOD FOR IN VITRO DISSOLUTION FOR SUBLINGUAL TABLETS Amongst the various routes of drug delivery, oral route is most preferred to the patient but administration of drugs has disadvantages such as hepatic first pass metabolism and enzyme degradation within the gastrointestinal tract. Other potential sites for drug administration include transmucosal routes (buccal, sublingual, nasal, rectal, vaginal etc.) of drug delivery with distinct advantages over peroral administration for systemic drug delivery. These advantages include drug stability due to avoidance of hepatic first pass metabolism and presystemic elimination within the gastrointestinal tract. The mucosal membranes are thinner and highly vascularized. Since drug delivery is faster, the transmucosal systems also allow the possibility of titrating drugs and thus provide enhanced flexibility. Also there is rapid drug absorption since the stratum corneum, the major barrier to absorption across the skin is absent. In vitro drug release studies have been employed as a quality control procedure in pharmaceutical production, in product development etc. The influence of technologically defined conditions has led to the development of a number of in vitro release methods for oral mucosal drug delivery systems; however no standard in vitro method has yet been developed. Different apparatus designed with varying conditions of operations, depending on the dosage form have been developed and used. Although a number of methods have been reported, the ideal method would be one where sink condition is maintained and dissolution time in vitro simulate dissolution in vivo. Thus although a number of methods have been reported, each has its own advantages and disadvantages and the choice of a particular method depends on a number of factors like purpose of the study, formulation factors and availability of the instrument. Research in oral mucosal drug delivery system is lacking in developing a standard method that can be universally accepted for in vitro release and hence there is a need to establish the crucial in vivo - in vitro correlation to validate these methods. The present invention includes design and development of a suitable in vitro drug release method for sublingual tablets using magnetic stirrer optimized according to the formulation with the following objective namely correlation between in vitro drug release and in vivo dissolution time for the sublingual tablets of drugs of varying solubilities. According to the present invention, the method consists of a set up which has a magnetic stirrer with a holder to hold a tablet. The magnetic stirrer may be stirred preferably at 120 rpm although the range can be from 100 to 1200 rpm depending on the formulation. The vessel in which release is carried out (carrying the release medium) may be made up of any suitable material preferably, but not limited to clear glass, clear plastic or any other clear polymer or inorganic material. The holder for the tablet may be made up of preferably stainless steel but may be made up of any other suitable material capable of maintaining integrity during the study. The mesh size of the holder is preferably 8# though the range may vary from 4# to 10# (the nominal mesh aperture size more than 1.7 mm). The release medium is preferably pH 6.0 phosphate buffer but may be any other medium including hydro organic mixtures capable of providing physiological simulation and/ or sink conditions. A suitable in vitro dissolution method designed could serve as a tool for routine quality control of sublingual tablets.

Documents:

346-MUM-2008-ABSTRACT(2-2-2009).pdf

346-MUM-2008-CLAIMS(2-2-2009).pdf

346-MUM-2008-CLAIMS(AMENDED)-(28-4-2014).pdf

346-MUM-2008-CLAIMS(AMENDED)-(4-7-2013).pdf

346-MUM-2008-CLAIMS(MARKED COPY)-(28-4-2014).pdf

346-MUM-2008-CLAIMS(MARKED COPY)-(4-7-2013).pdf

346-mum-2008-description (provisional).pdf

346-MUM-2008-DESCRIPTION(COMPLETE)-(2-2-2009).pdf

346-MUM-2008-DRAWING(2-2-2009).pdf

346-MUM-2008-FORM 1(2-2-2009).pdf

346-MUM-2008-FORM 18(20-4-2010).pdf

346-mum-2008-form 2(2-2-2009).pdf

346-MUM-2008-FORM 2(TITLE PAGE)-(2-2-2009).pdf

346-MUM-2008-FORM 2(TITLE PAGE)-(PROVISIONAL)-(18-2-2008).pdf

346-MUM-2008-FORM 3(2-2-2009).pdf

346-MUM-2008-FORM 5(2-2-2009).pdf

346-mum-2008-form-1.pdf

346-mum-2008-form-2.doc

346-mum-2008-form-2.pdf

346-mum-2008-form-3.pdf

346-MUM-2008-REPLY TO EXAMINATION REPORT(4-7-2013).pdf

346-MUM-2008-REPLY TO HEARING(28-4-2014).pdf