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D. Patil Namrata ¹, S. B. Gondkar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

Buccal route offers the advantage of avoiding first pass metabolism. Saxagliptin Hydrochloride in conventional dosage form is extensively metabolized by the liver. The Saxagliptin Hydrochloride is antidiabetic agent used in the treatment of type-II Diabetes mellitus. The oral bioavailability is 67%. The half-life of saxagliptin Hydrochloride is 2.5 hours and it undergoes hepatic metabolism. So, in order to improve the bioavailability and efficacy, we have prepared buccal patches of saxagliptin Hydrochloride. HPMC is one the polymers which is having good mucoadhesive property so therefore various formulations were developed by using release rate controlling HPMC K100M and Eudragit RL-100 by Solvent Casting technique. In addition to this propylene glycol - 400 was used as plasticizer and permeation enhancer respectively. Drug-excipients interaction study was proven if any. Buccal patches were characterized for number of parameters like Mechanical properties and , weight uniformity, thickness, Percent moisture loss, folding endurance, swelling index, surface pH, drug content uniformity, in-vitro residence time, drug-excipients interaction study, Mucoadhesive strength and in-vitro drug release study. 3² full factorial design was employed to study the effect of independent variables. The response of design was analyzed using Design Expert® trial version 7.0.0; and the tools of the software were used to draw Contour plot and 3D plot. On the basis of the software analysis, formulation F7 was selected as optimized formulation and evaluated for independent parameters. Optimized formulation showed 98.35 ± 0.52% dug release upto 6 hrs. Optimized formulation fulfils all necessary attributes required for Buccal Patch and can become a promising alternative to present marketed tablet of Saxagliptin Hydrochloride.

Keywords

Buccal Patches, Saxagliptin Hydrochloride (SXG HCL), Hydroxypropylmethyl Cellulose (HPMC), and Eudragit RL-100.

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S. B. Gondkar ¹, Nikita S. Malekar ², R. B. Saudagar ³

Affiliations
1 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
2 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN

Abstract

Niosomes or non ionic surfactant are microscopic lamellar structures which may be unilamellar or multilamellar. These are amphiphillic in nature, hence capable of entrapping both hydrophilic and lipophilic drugs for their controlled delivery. Niosomes are formulated by hydration of the lipid by the aqueous phase which may be either single surfactant or a mixture of surfactant with cholesterol. Stability of niosomes is greater as compared with other novel drug delivery techniques. Niosomes are widely used for delivery of many drugs especially in treatment of life threatening diseases, site specific targeting can be achieved with niosomes, and they are also used in diagnostic imaging purpose. This study is based upon the recent advances by which niosomes can be formulated and their application in controlled and effective delivery of variousdrugs. Niosomes represent a promising drug delivery module. They present a structure similar to liposome and hence they can represent alternative vesicular systems with respect to liposomes, due to the niosome ability to encapsulate different type of drugs within their multi environmental structure. Niosomes are thoughts to be better candidate's drug delivery as compared to liposomes due to various factors like cost, stability etc. Various types of drug deliveries can be possible using niosomes like targeting, ophthalmic, topical, parenteral, etc.

Keywords

Niosomes, Drug Delivery, Routes of Administrations, Applications.

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S. B. Gondkar ¹, Namrata D. Patil ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, KCT’S RGS College of Pharmacy, Anjaneri, Nashik 422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, KCT’S RGS College of Pharmacy, Anjaneri, Nashik, 422 213, Maharashtra, IN

Abstract

The oral route is most popular route for the administration of therapeutic agents because of the low cost of therapy and ease of administration lead to high levels of patient compliance. The most popular oral solid dosage forms are tablets and capsules. Oral fast dissolving films is relatively a new dosage form in which thin film is prepared using hydrophilic polymers which rapidly dissolves on tongue or Buccal cavity. The films overcome the fear of chocking. An ideal film should have the properties like pleasant taste, high stability, ease of handling and administration, no water necessary for application. Fast dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking water or chewing.

Keywords

Fast Dissolving Film, Film Forming Polymer, Solvent Casting Technique, Patented Technology.

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Pooja M. Nikam ¹, S. B. Gondkar ¹, R. B. Saudagar ¹

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik- 422003, IN

Abstract

The Overall prevalence rate for CNS pathology has demonstrated that approximately 1.5 billion people under going from disorders of central nervous system. The most distressing fact about delivery of drugs to the CNS is the presence of blood brain barrier that have a tendency to impair the drug distribution and denotes the major impediment for the development of CNS drugs. Neuropeptides and many drugs which are hydrophilic in nature, possibly will encompass the intricacy while passing the blood brain barrier. The net amount of delivered drug (medicinal agent) and its capability to gain access to the pertinent target sites are the main considering points for CNS drug development. In order to distribute the drugs into the CNS via passing the blood brain barrier, many new emerging approaches have been developed for example Magnetic drug targeting, chemical delivery Systems, Drug carrier systems (antibodies, liposomes or Nanoparticles). Among drug carrier system, Nanoparticles exhibit an impressive attention in the field of targeted drug delivery system because of possessing solid colloidal particles with a size range between 1- 1000nm. Gradual drug release reduced peripheral toxicity and potential totarget specific brain sites by crossing the blood brain barrier are major benefits contributed by Nanoparticles. In this review we will discuss the methodologies for targeting the brain site.

Keywords

Brain Barrier, Drug Delivery to Brain, Nanotechnology, Colloidal Drug Carriers.

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T. V. Kadam ¹, A. B. Darekar ¹, S. B. Gondkar ², R. B. Saudagar ³

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

In these studies describes a simple, accurate, precise and cost effective UV-visible spectrophotometric method for the estimation of Azelaic acid in pure and pharmaceutical formulations. The method is based on the measurement of absorbance of Azelaic acid solution in Phosphate buffer pH 6.8 at 204nm in the wavelength range of 200-400nm. The method obeys Beer's Lambert's law in the selected concentration range10-50 μg/ml in selected media. The slope, intercept and correlation coefficient were also calculated. Results of percentage recovery study shows that the method was not affected by the presence of common excipients in tablets. The parameters like linearity, precision, accuracy, sensitivity study i.e. limit of detection and limit of quantitation were studied according to International Conference on Harmonization (ICH) guidelines. The developed method was validated in terms of accuracy, precision, linearity, limit of detection and limit of quantitation which proves suitability of proposed method for routine estimation of Azelaic acid in pure and pharmaceutical formulations.

Keywords

UV-Visible Spectrophotometer, Method Development, Azelaic Acid.

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S. B. Gondkar ¹, P. Shewale Lankesh ², R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

The oral route is the most frequently used route for the administration of drugs. Many of the pharmaceutical dosage form are formulated as sustained release dosage form to retard the release of a therapeutic agent such that its appearance in the systemic circulation is prolonged and its plasma profile is sustained in duration. Tablets offer the lowest cost approach to sustained and controlled release dosage forms. Matrix tablets serves as an important tool for oral extended- release dosage forms. Hence, problems like patient compliance, drug targeting, local side effects, frequent administration and fluctuations in blood concentration levels. Conventional drug delivery systems are known to provide a prompt release of drug or immediate release drug product. Such immediate release products result in relatively rapid drug absorption and onset of accompanying pharmacodynamic effects. Hence, change in the operation is a suitable and optimized way to make the some drug more effective by slight alteration in the drug delivery. Pharmaceutical industries and academic laboratories have been focused on development of novel drug delivery system or modified release dosage form rather investigation and development of new drug. Advance in technology have resulted in novel modified release dosage form. In contrast to conventional form, modified release products provide either delayed release or extended release of drug.

Keywords

Hydrophilic and Hydrophobic Polymers, Matrix Tablet, Sustained Release Matrix Type Drug Delivery.

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Pooja M. Nikam ¹, S. B. Gondkar ¹, R. B. Saudagar ²

Affiliations
1 Department of Pharmaceutics, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik, 422003, IN
2 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nasik, 422003, IN

Abstract

Nanotechnology is the science in which the particle having the size below 1000nm.Theimportance of nanotechnology in drug delivery is in the concept and ability to manipulate molecules and supramolecular structures for producing devices with programmed functions. One of the major application areas of nanotechnology in pharmacy is nanoparticular drug delivery system. Preparation of nanocrystals to improve the solubility of poorly water- soluble drug for oral delivery is also one of the important applications. Drug nanocrystals are crystals with a size in the nanometre nanoparticle with a crystalline character .The use of drug Nanocrystals is an universal formulation approach to increase the therapeutic performance of these drugs in any rout of administration.

Keywords

Nanocrystal, Top Down, Bottom Up, Application.

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Nikita S. Malekar ¹, S. B. Gondkar ², R. B. Saudagar ³

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
2 Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, R.G.Sapkal College of Pharmacy, Anjenari, Nashik-422213, Maharashtra, IN

Abstract

Nasal therapy also called "Nasya Karma" has been recognized form of treatment in the Ayurvedic. System of Indian Medicine. Nowadays many drugs have better systemic bioavailability through nasal route as compared to oral administration. The nose is also considered an attractive route for needle-free vaccination and for systemic drug delivery, especially when rapid absorption and effect are desired. The nasal delivery is a feasible alternative to oral or parenteral administration for some drug because of the high permeability of the nasal epithelium, rapid drug absorption across this membrane and avidance of first pass metabolism. Prolonged drug delivery can be achieved by various new dosage forms like in-situ gel. In-situ forming polymeric formulation are drug delivery system that is in sol form before administration in the body, but once administered, undergoes gelation in-situ to form a gel. In-situ nasal drug delivery system is the type of mucoadhesive drug delivery system. Now a days insitu gel has been used as vehicle for the drug delivery of the drug for both local treatment and systemic effect. In-situ nasal gel drug delivery system is advantageous over the conventional drug delivery system like sustained and prolonged release of drug, reduced frequency of administration, improved patient compliance and comfort.

Keywords

Nasal Drug Delivery, Nasal In-Situ Gel, Mucoadhesive Drug Delivery System.

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Varsha R. Sandhan ¹, S. B. Gondkar ¹, R. B. Saudagar ¹

Affiliations
1 Department of Quality Assurance Techniques, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik-422213, Maharashtra, IN

Abstract

The poor bioavailability and therapeutic response exhibited by conventional ophthalmic solutions due to rapid precorneal elimination of drug may be overcome by the use of ophthalmic gel systems. The purpose of the present study was to develop ophthalmic gel formulations of ketoconazole. Intraocular delivery of topically applied drugs such as ketoconazole is hampered by elimination of the solution due to tear turnover, so an mucoadhesive gel was formulated. Ketoconazole gels were prepared using sodium carboxymethylcellulose (NaCMC) as a mucoadhesive polymer and xanthan gum as a viscosity increasing agent. Gels were evaluated for various parameters like appearance, pH, drug content, gel strength, bioadhesion, viscosity, In-vitro drug release, isotonisity, sterility, antifungal activity, ocular irritancy and stability studies. The gel strength, bioadhesion and isotonisity shown quality parameter for ophthalmic formulation. The optimized formulation containing 1% w/v Na CMC and 0.2% w/v xanthan gum have shown 97.66% drug release up to 8 hrs. This is sufficient for antifungal activity. Diffusion studies have shown that a Korsmeyers-peppas is the best-fit model. This study found that an optimized formulation having improved viscosity and better mucoadhesive property may improve the bioavaibility of ocular administration of ketoconazole in gel form and can be alternative to the conventionally administered oral formulation and effectively used to prolong residence time.

Keywords

Ophthalmic Drug Delivery, Bioavaibility, Mucoadhesive Polymer, Fungal Keratitis.

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