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insitu hydrogel

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regional institute of medical sciences and search, MGU

controlled release of insitu forming moxifloxacin and ketorolac hydrogel for ophthalmic drug delivery

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insitu hydrogel
? To formulate and evaluate hydrogel of moxifloxain & ketorolac in view of increasing precorneal residence time & bioavailability of drugs ? Ion sensitive (sodium alginate), temperature sensitive ( poloxamer) ? HPMC as viscosity enhancing agent.
1)Literature survey 2)Collection of drugs, polymers & other exicipents. 3)Standardization of drugs 4)Formulation development
A. Preformulation studies Identification 1) Determination of melting point 2) Solubility – water ,ethanol, acetone,2-propanol 3) IR spectroscopy- comparison of sample with standard 4) Compatibility study B.Selection of vehicle C.Formulation optimization by factorial design D.Methods for in situ hydrogel preparation
? Moxifloxacin ? Ketorolac ? Electronic balance ? Sodium alginate ? Magentic stirrer ? Poloxamer ? Digital pH meter ? HPMC ? Brookfield viscometer ? Sodium hydroxide ? UV-visible spectrophotometer ? Hydrochloric acid ? Autoclave ? Potassium dihydrogen phosphate ? Incubator ? Disodium hydrogen phosphate ? Open end tube ? Glacial acetic acid ? FI-IR spectrometer ? Ammonium acetate ? Citric acid monohydrate
Optimization by factorial design Gelling Sl no Formulation Variable level Actual agent code in coded form units X1 X2 X1 X2(%w/v) (%w/v) Sodium 1 F1 -1 +1 1 1.0 alginate 2 F2 +1 -1 3 0.5 3 F3 -1 -1 1 0.5 4 F4 +1 +1 3 1.0 poloxamer 5 F5 -1 +1 15 1.0 6 F6 +1 -1 25 0.5 7 F7 -1 -1 15 0.5 8 F8 +1 +1 25 1.0
D. Evaluation parameters ? Appearance ? pH ? Invitro gelation studies ? Rheological studies ? Drug content ? In vitro release studies ? Sterility ? Ocular irritation studies ? Stability studies
1.Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O et al. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol 2005;50:S32–S45. 2. Mcgee DH, Holt WF, Kastner PR, Rice RL. Safety of moxifloxacin as shown in animal and in vitro studies. Surv ophthol 2005;50(6):S46-S53. 3. Mason BL, Alfonso EC, Miller D. In-use study of potential bacterial contamination of ophthalmic moxifloxacin. J Cataract Refract Surg 2005;31:1773–6. 4. Silver LH, Woodside AM, Montgomery DB. Clinical safety of moxifloxacin ophthalmic solution 0.5% (vigamox) in pediatric and nonpediatric patients with bacterial conjunctivitis. Surv Ophthalmol 2005;50:S55–S63. 5. Kowalski RP, Dhaliwal DK, Karenchak LM, Romanowsk EG, Mah FS, Ritterband DC. Gatifloxacin and moxifloxacin: an in vitro susceptibility comparison to levofloxacin, ciprofloxacin, and ofloxacin using bacterial keratitis isolates. Am J Ophthalmol 2003;136:500–5.
6. Burka JM, Bower KS, vanroeke CR, Stutzman RD, Kuzmowych CP, Howard RS. The effect of fourth-generation fluoroquinolones gatifloxacin and moxifloxacin on epithelial healing following photorefractive keratectomy. Am J Ophthalmol 2005;140:83–7. 7. Solomon R, Donnenfeld ED, Perry HD, Snyder RW, Nedrud C, Stein J. Penetration of topically applied gatifloxacin 0.3%, moxifloxacin 0.5%, and ciprofloxacin 0.3% into the aqueous humor. Ophthalmology 2005;112:466-9. 8. Patel UL, Chotai NP, Nagda CD, Patel MP, Patel KN. Formulation and in vitro evaluation of moxifloxacin hydrochloride ophthalmic inserts. Int J Pharm Res 2009;1(1):23-30. 9. Edsman K, Carlfors J, Petersson R . Rheological evaluation of poloxamer as an in situ gel for ophthalmic use. Eur J Pharm Sci 1998;6:105–12. 10. Gil HJ, Hyun I, Chi SC. Release of flurbiprofen from poloxamer 407 gel. Arch Pharm Res 1994;17(4):240-43.
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insitu hydrogel

  • 3. ? To formulate and evaluate hydrogel of moxifloxain & ketorolac in view of increasing precorneal residence time & bioavailability of drugs ? Ion sensitive (sodium alginate), temperature sensitive ( poloxamer) ? HPMC as viscosity enhancing agent.
  • 4. 1)Literature survey 2)Collection of drugs, polymers & other exicipents. 3)Standardization of drugs 4)Formulation development
  • 5. A. Preformulation studies Identification 1) Determination of melting point 2) Solubility – water ,ethanol, acetone,2-propanol 3) IR spectroscopy- comparison of sample with standard 4) Compatibility study B.Selection of vehicle C.Formulation optimization by factorial design D.Methods for in situ hydrogel preparation
  • 6. ? Moxifloxacin ? Ketorolac ? Electronic balance ? Sodium alginate ? Magentic stirrer ? Poloxamer ? Digital pH meter ? HPMC ? Brookfield viscometer ? Sodium hydroxide ? UV-visible spectrophotometer ? Hydrochloric acid ? Autoclave ? Potassium dihydrogen phosphate ? Incubator ? Disodium hydrogen phosphate ? Open end tube ? Glacial acetic acid ? FI-IR spectrometer ? Ammonium acetate ? Citric acid monohydrate
  • 7. Optimization by factorial design Gelling Sl no Formulation Variable level Actual agent code in coded form units X1 X2 X1 X2(%w/v) (%w/v) Sodium 1 F1 -1 +1 1 1.0 alginate 2 F2 +1 -1 3 0.5 3 F3 -1 -1 1 0.5 4 F4 +1 +1 3 1.0 poloxamer 5 F5 -1 +1 15 1.0 6 F6 +1 -1 25 0.5 7 F7 -1 -1 15 0.5 8 F8 +1 +1 25 1.0
  • 8. D. Evaluation parameters ? Appearance ? pH ? Invitro gelation studies ? Rheological studies ? Drug content ? In vitro release studies ? Sterility ? Ocular irritation studies ? Stability studies
  • 9. 1.Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O et al. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol 2005;50:S32–S45. 2. Mcgee DH, Holt WF, Kastner PR, Rice RL. Safety of moxifloxacin as shown in animal and in vitro studies. Surv ophthol 2005;50(6):S46-S53. 3. Mason BL, Alfonso EC, Miller D. In-use study of potential bacterial contamination of ophthalmic moxifloxacin. J Cataract Refract Surg 2005;31:1773–6. 4. Silver LH, Woodside AM, Montgomery DB. Clinical safety of moxifloxacin ophthalmic solution 0.5% (vigamox) in pediatric and nonpediatric patients with bacterial conjunctivitis. Surv Ophthalmol 2005;50:S55–S63. 5. Kowalski RP, Dhaliwal DK, Karenchak LM, Romanowsk EG, Mah FS, Ritterband DC. Gatifloxacin and moxifloxacin: an in vitro susceptibility comparison to levofloxacin, ciprofloxacin, and ofloxacin using bacterial keratitis isolates. Am J Ophthalmol 2003;136:500–5.
  • 10. 6. Burka JM, Bower KS, vanroeke CR, Stutzman RD, Kuzmowych CP, Howard RS. The effect of fourth-generation fluoroquinolones gatifloxacin and moxifloxacin on epithelial healing following photorefractive keratectomy. Am J Ophthalmol 2005;140:83–7. 7. Solomon R, Donnenfeld ED, Perry HD, Snyder RW, Nedrud C, Stein J. Penetration of topically applied gatifloxacin 0.3%, moxifloxacin 0.5%, and ciprofloxacin 0.3% into the aqueous humor. Ophthalmology 2005;112:466-9. 8. Patel UL, Chotai NP, Nagda CD, Patel MP, Patel KN. Formulation and in vitro evaluation of moxifloxacin hydrochloride ophthalmic inserts. Int J Pharm Res 2009;1(1):23-30. 9. Edsman K, Carlfors J, Petersson R . Rheological evaluation of poloxamer as an in situ gel for ophthalmic use. Eur J Pharm Sci 1998;6:105–12. 10. Gil HJ, Hyun I, Chi SC. Release of flurbiprofen from poloxamer 407 gel. Arch Pharm Res 1994;17(4):240-43.