LIST OF SYMBOLS AND ABBREVIATIONS
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1 List of Symbols and Abbreviations LIST OF SYMBOLS AND ABBREVIATIONS λ max : Absorption Maxima AZT : Azithromycin Dihydrate ANOVA : Analysis of Variance BI : Bleeding Index CBL : Carbopol cm : Centimeter cps : Centipoises CAL : Clinical Attachment Level CD4 : Cluster Differenciation 4 Conc. : Concentration 60 Co : Cobalt 60 o C : Degree Centigrade F : Degree Farenheit DNA : Deoxyribose Nucleic Acid DSC : Differential Scanning Calorimetry DMF : Dimethyl Formamide DDS : Drug Delivery System eg : Example FT-IR : Fourier Transform Infrared Spectroscopy FDA : Food and Drug Administration GI : Gastro Intestinal GIT : Gastro Intestinal Tract GP : Glycerophosphate GI : Gingival Index g : Gram/s g/cm 3 : Gram per cubic centimeter h : Hour/s HEC : Hydroxy Ethyl Cellulose HPMC : Hydroxy Propyl Methyl Cellulose IM : Intra Muscular IV : Intra Venous Kg : Kilogram I
2 List of Symbols and Abbreviations KGray : Kilo Gray lt : Litre LCST : Lower Critical Solution Temperature LVET : Low Volume Eye Test µg : Microgram μm : Micrometer mg : Milligram ml : Milliliter min : Minutes MTX : Methotrexate Sodium M : Molarity nm : Nano Meter % : Percent PF-127 : Pluronic F-127 PF-68 : Pluronic F-68 PI : Plaque Index PCL : Polycarbophil PEO : Poly Ethylene Oxide PPO : Poly Propylene Oxide PPD : Probing Pocket Depth RH : Relative Humidity RA : Rheumatoid Arthritis RNA : Ribose Nucleic Acid rpm : Rotations per minute SEM : Scanning Electron Microscopy sec : Seconds S.D. : Standard Deviation SC : Subcutaneous UV : Ultra Violet UCST : Upper Critical Solution Temperature w/v : Weight/volume WHO : World Health Organization yr : Year/s II
3 LIST OF TABLES List of Tables Sl. Table Title of the Table Page LCSTs of several typical thermosensitive polymers Therapeutic uses, dosage and administration of Methotrexate Patents related to in situ Standard plot data of Azithromycin dihydrate in 0.1 N HCl solution Standard plot data of Pilocarpine hydrochloride in simulated lachrymal fluid Standard plot data of Methotrexate in ph 7.4 phosphate buffer Standard plot data of Losartan potassium in ph 1.2 hydrochloric acid buffer Formulation chart of Azithromycin dihydrate in situ Formulation chart of pilocarpine hydrochloride in situ Formulation chart of Methotrexate sodium in situ Formulation chart of Losartan potassium floating in situ Parameters for diffusion study Static method Parameters for diffusion study Dynamic method Criteria for clinical parameters and their ratings Ocular parameters and their scorings - Draize Test FT-IR spectral data of azithromycin dihydrate and in situ gel A8 Characteristics of prepared Azithromycin dihydrate in situ In vitro release data of Azithromycin dihydrate in situ Model fitting data for prepared Azithromycin in situ III
4 Sl. List of Tables Table Title of the Table Page Results of clinical parameters studied for Azithromycin dihydrate in situ in human patients with chronic periodontitis Stability study data of optimized Azithromycin dihydrate in situ gel (A8) FT-IR spectral data of Pilocarpine hydrochloride and in situ gel P5 Characteristics of prepared Pilocarpine hydrochloride in situ ph & observations during Isotonicity test (Pilocarpine in situ ) In vitro release data of Pilocarpine hydrochloride in situ Model fitting data for prepared Pilocarpine hydrochloride in situ Scoring of P5 for various ocular parameters during ocular irritation study Stability study data of Pilocarpine hydrochloride in situ gel (P5) FT-IR spectral data of methotrexate pure drug and in situ gel M4 Gelation temperature of Methotrexate sodium in situ Gelation time of Methotrexate sodium in situ Drug content values for Methotrexate sodium in situ Observed viscosity values for Methotrexate sodium in situ Syringeability time for Methotrexate in situ In vitro drug diffusion data of Methotrexate sodium in situ by Static Method (M2-M7) 191 IV
5 List of Tables Sl. Table Title of the Table Page In vitro drug diffusion data of Methotrexate sodium in situ by Static Method (M8-M13) In vitro drug diffusion data of Methotrexate sodium in situ by Dynamic Method (M2-M7) In vitro drug diffusion data of Methotrexate sodium in situ by Dynamic Method (M8-M13) In vitro diffusion data of Methotrexate sodium in situ (static & dynamic) Calculated t & tabulated t values of Methotrexate sodium in situ Data obtained from Peppas model fitting for Methotrexate in situ Stability data of Methotrexate in situ Measured ph values of Losartan potassium in situ FT-IR spectral data of pure Losartan potassium and formulation L4 DSC thermograms data of pure Losartan potassium and Formulation L4 Characteristics of prepared Losartan potassium floating in situ Characteristics of prepared Losartan potassium floating in situ In vitro release data of Losartan potassium from floating in situ (L1 to L6) In vitro release data of Losartan potassium from floating in situ (L7 to L12) Data of various parameters of model fitting for in vitro release of Losartan potassium from in situ Stability data of Losartan potassium in situ V
6 List of Figures Sl. Figure LIST OF FIGURES Title of the Figure Schematic illustration showing the different types of responses of intelligent polymer systems to environmental stimuli. Schematic representation of sol-to-gel transition in stimuli-sensitive polymers Mechanism of in situ physical gelation driven by hydrophobic interactions Tissue locations applicable for in situ gel-based drug delivery systems Schematic of relative ionic hydrogel swelling as a function of ph Schematic representation of glucose-sensitive swelling changes in a poly(gema) Con A hydrogel Schematic representation of antigen responsive swelling changes in a Antibody immobilized polymer chain Drug concentration at site of therapeutic action after delivery as conventional injection and as a temporal controlled release system Drug delivery from an ideal distribution controlled release system. Schematic representation of normal tooth structure and periodontal pocket The plaque-bacteria association with tooth surface and periodontal tissues Schematic localization of an intragastric floating system in the stomach Picturisation of various gastro retentive formulations location in the Stomach UV Spectra of Azithromycin dihydrate in 0.1 N HCl Standard plot of Azithromycin dihydrate in 0.1N HCl solution VI Page
7 Sl. Figure Title of the Figure List of Figures UV spectrum of Pilocarpine Hydrochloride in simulated lachrymal fluid Standard Graph of Pilocarpine Hydrochloride in simulated lachrymal fluid UV spectrum of Methotrexate sodium in ph 7.4 phosphate buffer Standard plot of Methotrexate Sodium in ph 7.4 phosphate buffer UV spectrum of Losartan Potassium in ph 1.2 hydrochloric acid buffer Standard plot of Losartan potassium in ph 1.2 hydrochloric acid buffer VII Page Apparatus for testing syringeability time Apparatus for diffusion testing by static method Placement of Azithromycin dihydrate in situ gel in periodontal pocket Measurement of pocket depth (Metallic wire of acrylic template is taken as reference) Sterility test for aerobic bacteria in nutrient Agar media A = Control, B = Test Sterility test for aerobic bacteria in nutrient broth media A = Control, B = Test Sterility test for anaerobic bacteria in fluid thioglycollate media A = Control, B = Test FT-IR spectra of Azithromycin dihydrate and in situ gel A8 Viscosity of formulations A4 and A8 as a function of temperature Sigma plot of viscosity, gelation temperature and syringeability time In vitro drug release profile of Azithromycin dihydrate from in situ (A1-A4)
8 Sl. Figure Title of the Figure List of Figures In vitro drug release profile of Azithromycin dihydrate from in situ (A5-A8) VIII Page Periodontal pack given after placement of in situ gel Baseline measurement of pocket depth at test site (Group A) Baseline measurement of pocket depth at control site (Group B) Measurement of pocket depth after 3 months at test site (Group A) Measurement of pocket depth after 3 months at test site (Group B) Drug content in Azithromycin dihydrate in situ when stored at 5 ± 3 C for 12 months Drug content in Azithromycin dihydrate in situ when stored at 25 ± 2 C & 60 ± 5 % RH for 6 months Sterility test for aerobic and anaerobic bacteria in fluid thioglycollate media. A = Test, B = Control, C= Gram ve control & D = Gram +ve bacteria control Sterility test for fungi in soybean casein digest media. A = Control, B = Test, C = Fungi control FT-IR spectra of Pilocarpine hydrochloride and in situ gel P Blood cells with marketed product [Pilocar Drops] Blood cells with Pilocarpine hydrochloride in situ In vitro drug release profile of Pilocarpine hydrochloride from in situ (P1-P3) In vitro drug release profile of Pilocarpine hydrochloride from in situ (P4-P6) Rabbits used for ocular irritation studies rmal rabbit eye (Before instillation) Instillation of Pilocarpine in situ gel at test site (right eye)
9 List of Figures Sl. Figure Title of the Figure Page Instillation of normal saline at control site (left eye) Observation of eye after instillation of Pilocarpine in situ gel Pilocarpine in situ gel retained at the test site after 6 hours Pilocarpine in situ gel retained at the test site after 12 hours %Drug content in Pilocarpine hydrochloride in situ when stored at 5 ± 3 C for 12months % Drug content in Pilocarpine hydrochloride in situ when stored at 25 ± 2 C & 60 ± 5 % RH for 6 months Sterility test for aerobic bacteria in Nutrient broth media Sterility test for anaerobic bacteria in fluid thioglycollate media FT-IR spectra of Methotrexate pure drug and in situ gel M4 Gelation temperature of Methotrexate sodium in situ Gelation time of Methotrexate sodium in situ Percentage drug content in Methotrexate sodium in situ Viscosity profile of Methotrexate sodium in situ Syringeability time for Methotrexate sodium in situ situ by static method (M2-M4) situ by static method (M5-M7) situ by static method (M8-M10) situ by static method (M9-M13) IX
10 List of Figures Sl. Figure Title of the Figure In vitro drug diffusion data of Methotrexate sodium in situ by dynamic method (M2-M4) situ by dynamic method (M5-M7) situ by dynamic method (M8-M10) situ by dynamic method (M11-M13) In vitro diffusion of Methotrexate sodium in situ by static and dynamic methods % Drug content in Methotrexate sodium in situ when stored at 5 ± 3 C for 12 months % Drug content in Methotrexate sodium in situ when stored at 25 ± 2 C & 60 ± 5 % RH for 6 months FT-IR spectra of pure Losartan potassium and formulation L4 DSC thermograms of pure Losartan potassium and Fomrulation L4 Effect of gellan gum on gelation time & floating lag time Effect of HPMC on gelation time & floating Lag time Effect of calcium carbonate on gelation time & floating lag time Photograph showing the appearance of gellan gel (L4) formed in ph 1.2 In vitro drug release profile from Losartan potassium in situ (L1-L4) In vitro drug release profile from Losartan potassium in situ (L5-L8) In vitro drug release profile from Losartan potassium in situ (L9-L12) Page X
11 List of Figures Sl. Figure Title of the Figure % Drug content in Losartan potassium in situ when stored at 25±2 C/60±5% RH for 12 months % Drug content in Losartan potassium in situ when stored at 30±2 C/65 ± 5 % RH for 12 months % Drug content in Losartan potassium in situ when stored at 40±2 C/75 ± 5 % RH for 6 months Page XI
12 XII
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