FORMULATION AND EVALUATION OF



PREPARATION AND EVALUATION OF NSAID NANOEMULSION

M.PHARM DISSERTATION PROTOCOL

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SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA

BY

ANJANI PRASAD REDDY.VANGA

I M.PHARM

UNDER THE GUIDANCE OF

Dr. B. PRAKASH RAO

Professor

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DEPARTMENT OF PHARMACEUTICAL TECHNOLOGY.

KARNATAKA COLLEGE OF PHARMACY

BENGALURU-560064

(2010-2011)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BENGALURU.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

| | | |

| | |ANJANI PRASADREDDY. V |

|1 | |Karnataka College Of Pharmacy |

| | |# 33/2 Thirumenahalli |

| |Name and Address of Candidate |Hegde Nagar Main Road |

| | |Bengaluru-560064. |

| | |PERMANENT ADDRESS |

| | |S/O V.SUBBAREDDY, |

| | |H.No:-3-28-18/18, |

| | |Brindavan garden’s , 3rd lane, GUNTUR |

| | |Dist: Guntur. |

| | |State: Andhra Pradesh-522403. |

| | | |

|2 |Name of the Institution |Karnataka college of pharmacy |

| | |# 33/2 Thirumenahalli |

| | |Hegde Nagar Main Road |

| | |Bengaluru-560064. |

| | | |

|3 |Course of the Study and Subject |M. PHARMACY |

| | |(PHARMACEUTICAL TECHNOLOGY) |

| | | |

|4 |Date of Admission |03-NOV-2010 |

| |Title of the Project |

|5 | |

| |PREPARATION AND EVALUATION OF NSAID NANOEMULSION. |

| | |

| | |

| | |

|6. |BRIEF RESUME OF INTENDED WORK |

| | |

|6.1 |NEED FOR THE STUDY |

| | |

| |Nanotechnology comprises technological developments on the nanometer scale, usually 0.1-1000nm. The use of nanotechnology in the field of |

| |pharmaceuticals has grown over the last few years. The pharmaceuticals developed based on the nanotechnology are termed as “NANOPHARMACEUTICALS”. The|

| |various nanopharmaceuticals currently being used or in the process of development of Nano emulsions, nanosuspensions, nanospheres, nanotubes, |

| |nanocells etc. |

| |Nanoemulsions are a group of dispersed particles used for pharmaceutical and biomedical aids and vehicles that show great promise to the future of |

| |drug therapies, cosmetics, diagnostics and biotechnologies. Nanoemulsions are defined as the oil-in-water (o/w) emulsions with mean droplet diameters|

| |ranging from 50 to 1000nm. Usually, the average droplet diameters ranging from 100 to 500 nm. The particles can exist as water-in-oil and |

| |oil-in-water forms, where the core of the particle is either water or oil respectively. Nanoemulsions are made from surfactants approved for human |

| |consumption and common food substances that are “Generally recognised as safe” by the FDA. The emulsions are easily produced in large quantites by |

| |mixing a water immiscible oil phase into an aqueous phase with a high stress, a mechanical extrusion process that is available worldwide. |

| |The nanoemulsions are also referred as mini emulsions, ultrafine emulsions and sub micron emulsions. Phase behaviour studies have shown that the size|

| |of the droplets is governed by the surfactant phase structure at the inversion point induced by either temperature or composition. Studies on the |

| |nanoemulsion formation by the phase inversion temperature method have shown a relationship between minimum droplet size and complete solubilisation |

| |of the oil in a microemulsion bicontinuos phase independenty of whether the initial phase equilibrium is single or multiphase. |

| |Due to their small droplet size nanoemulsions possess stability against sedimentation or creaming with Ostwald ripening forming the main mechanism of|

| |nanoemulsion breakdown. |

| |Non steroidal anti-inflammatory drug (NSAID) has been used in the treatment of various kinds of pains, inflammation, and arthritis. |

| | |

|6.2 |REVIEW OF LITERATURE |

| |Ganciclovir plays an important role in the treatment of ocular viral infections. The aim of the present study was to investigate the comparative |

| |potential of different mucoadhesive nano formulations for the topical ocular delivery of Ganciclovir. Ganclovir mucoadhesive Nanoemulsions were |

| |prepared by the reverse-phase evaporation technique. The formulations were evenly round in shape with mean particle size in the range of 23-200 nm. |

| |These results indicated the nonirritant and nontoxic nature of the developed formulations. (Akhter S, 2011) |

| | |

| |The plan this work was to develop and characterize semisolid topical formulations containing nimesulide-loaded nanoemulsion. The spontaneous |

| |emulsification method was used to prepare the nanoemulsion. The drug-loaded nanoemulsion formulation was incorporated in Carbopol 940 gels. The |

| |semisolid dosage forms showed yellowish, glossy and homogeneous aspect after the incorporation of the nanoemulsion. The recovery of nimesulide and |

| |the pH values for the gels containing nanoemulsion remained constant during storage (120 days). For the formulation, the rheograms exhibited a |

| |non-Newtonian behaviour presenting pseudo plastic characteristics and shear thinning. The rheograms were adjusted to Ostwald's model showing |

| |regression coefficients higher than 0.9900. None thixotropic phenomenon was experimentally detected under the test conditions for all formulations. |

| |(Alves PM, 2005) |

| | |

| |The aim of this work was to evaluate the in vitro performance of a nebulized nanoemulsion formulation which had been optimised previously. To do so, |

| |a transparent nanoemulsion preparation containing 1.5 mg/ml of budesonide was prepared and diluted to achieve concentrations of 250 and 500 μg/ml |

| |budesonide. The in vitro characteristics of the diluted nanoemulsions were then compared with the commercially available suspension of budesonide |

| |when nebulized using a jet and a vibrating mesh nebulizer. A smaller MMAD with improved aerosol output was observed in the nanoemulsion preparations |

| |compared with the corresponding suspension formulations indicating an improved in vitro performance for the nanoemulsion-based preparations. (Amani |

| |A, 2010) |

| |A promising strategy based on the antisense oligonucleotides against the Plasmodium falciparum topoisomerase II has been considered using cationic |

| |nanoemulsion as oligonucleotide delivery system. Phosphodiester and chemically modified phosphorothioate oligonucleotides bearing negative charges |

| |were adsorbed on positively charged emulsion composed of medium chain triglycerides. The physicochemical properties of the complexes were |

| |determined, as well as their stability in culture medium. Their interaction with erythrocytes through haemolysis, binding experiments and confocal |

| |microscopy were also evaluated. Finally, the in vitro evaluation of parasite growth and reinfection capacity was performed. The overall results |

| |showed that antisense oligonucleotides against P. falciparum topoisomerase II gene can be efficiently adsorbed onto a cationic nanoemulsion forming |

| |complexes. (Bruxel F, 2011) |

| | |

| |Melasma hyperpigmentation is an acquired disorder affecting the female population. The present study was to determine the ability of a botanical |

| |extract to reduce observable hyperpigmentation. The extract from heartwood of Artocarpus incisus was formulated into nanoemulsions, and the |

| |depigmenting efficacy of the formulated nanoemulsion was determined in vivo. The nanoemulsion containing the extract was formulated and prepared by |

| |the phase inversion technique. The depigmenting efficacy was observed following topical application of the formulated nanoemulsion to UVB-stimulated |

| |hyper pigmented dorsal skin of C57BL/6 mice. A strongly visible decrease in hyperpigmentation was observed after six weeks of treatment. The applied |

| |areas would return to their original colour after treatment was stopped for four weeks. (Buranajaree S, 2011) |

| |Nanoemulsion of amlodipine besilate was developed by spontaneous emulsification method to enhance the solubility and oral bioavailability of |

| |amlodipine besilate. The selected formulations from nanoemulsion region were subjected to droplet size analysis, partitioning study and in vitro drug|

| |release. The optimal formulation was characterized by transmission electron microscopy (TEM). The pharmacokinetics and bio- distribution studies of |

| |the optimized radiolabeled formulation in mice shows a relative bioavailability of 475% against amlodipine besilate suspension. In almost all the |

| |tested organs, the uptake of amlodipine besilate nanoemulsion was significantly higher than amlodipine besilate suspension, also confirming the |

| |efficacy of nano-sized formulation at therapeutic site. The residence time of nanoemulsion further signifies the advantage of nanoemulsions as drug |

| |carriers for enhancing bioavailability of amlodipine besilate.(Chhabra G, 2011) |

| |The aim of the current study was to develop a novel pea protein-based emulsifier which was used in the production of oil in water (O/W) |

| |nanoemulsions. The regions of kinetically stabilized O/W emulsions were individuated in a pseudoternary diagram containing different pea protein, |

| |sunflower oil, and water fractions. The stable O/W emulsion region was widened by the addition of NaCl to the aqueous phase or, to a more significant|

| |extent, by high pressure homogenization processing. The high pressure homogenization treatment caused the formation of very fine emulsions in the |

| |nanometric range ( ................
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