protocol of 2012 project in M.Pharm pharmaceutics

1. welcome

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.
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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
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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.

11. Thank you