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PREPARED BY :-
BHASKAR DEWANGAN
B. Pharmacy
University Institute Of Pharmacy
Pt. R. S. University, Raipur(C.G.)
Ophthalmic
Solutions and
Suspensions
 Ophthalmic drug delivery
 Pharmaceutic requirements
 Packaging ophthalmic solutions and
suspensions
 Proper administration of ophthalmic solutions
and suspensions
infections
allergic or inflammation
elevated intraocular pressure
dry-eye
Special consideration for ophthalmic
preparations:
 sterility
 preservation
 isotonicity
 buffering
 viscosity
 ocular bioavailability and packaging
 Ophthalmic solutions/suspensions could be
sterilized by
- autoclaving at 121C for 15 minutes
- bacterial filters
 To maintain sterility during patient use,
antimicrobial preservatives generally are
included in ophthalmic formulations.
The preservatives used in ophthalmic
solutions/suspensions are
 benzalkonium chloride , 0.004-0.01%;
 benzethonium chloride, 0.01%;
 chlorobutanol, 0.5%;
 phenylmercuric acetate, 0.004%;
 phenylmercuric nitrite, 0.004%;
 thimerosal, 0.005-0.01%
 Isotonic solution: a solution that has the
same salt concentration as the normal cells
of the body and the blood.
 Hypotonic, solutions with a lower osmotic
pressure than body fluids or a 0.9% sodium
chloride solution are commonly referred to
as hypotonic.
 Hypertonic, solutions have a greater osmotic
pressure are termed hypertonic.
 Boric acid has a molecular weight of 61.8, and thus
61.8 g in 1000 g of water should produce a freezing
point of -1.86C. therefore:
1.86(C )/0.52(C )=61.8 (g)/x(g)
X=17.3 g
 17.3 g of boric acid in 1000g of water theoretically
should produce a solution isosmotic with tears and
blood.
The aims for adjusting the pH of an
ophthalmic preparation:
 for greater comfort to the eye;
 to render the formulation more stable;
 to enhance the aqueous solubility of the drug;
 to enhance the drug’s bioavailability;
 to maximize preservative efficacy.
 The pH of normal tears is considered to be about
7.4.
 For maximum comfort, an ophthalmic solution
should have the same pH as the lacrimal fluid.
 A compromise pH is generally selected for solution
and maintained by buffers to permit the greatest
activity while maintaining stability.
 Viscosity for ophthalmic solutions is
considered optimal in the range of 15 to 25
cps.
 In the preparation of ophthalmic solutions, a
suitable grade of methylcellulose or other
thickening agent (hydroxypropyl
methylcellulose, polyvinyl alcohol) is
frequently added to increase the viscosity.
There are physiologic factors which can
affect a drug’s ocular bioavailability,
including
 protein binding,
 drug metabolism
 lacrimal drainage
Soft plastic containers
2, 2.5, 5, 10, 15, 30 mL
 wash hands thoroughly
 inspect for color and clarity
 be shaken thoroughly prior to
administration (ophthalmic
suspensions)
 not to touch the dropper to the
eye, eyelid or any other surface
www.pharmatechnologyindex.com
www.visongain.com
www.jpionline.org
www.biopharminternational.com
www.avonex.com
www.ondrugdelivery.com
www.bd.com
www.ec21.com
www.harikrushnatechnopride.tradeindia.c
om
www.pharmtech.com
www.baxterbiopharmasolutions.com
Ophthelmic prepartion

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Ophthelmic prepartion

  • 1. PREPARED BY :- BHASKAR DEWANGAN B. Pharmacy University Institute Of Pharmacy Pt. R. S. University, Raipur(C.G.) Ophthalmic Solutions and Suspensions
  • 2.  Ophthalmic drug delivery  Pharmaceutic requirements  Packaging ophthalmic solutions and suspensions  Proper administration of ophthalmic solutions and suspensions
  • 3. infections allergic or inflammation elevated intraocular pressure dry-eye
  • 4. Special consideration for ophthalmic preparations:  sterility  preservation  isotonicity  buffering  viscosity  ocular bioavailability and packaging
  • 5.  Ophthalmic solutions/suspensions could be sterilized by - autoclaving at 121C for 15 minutes - bacterial filters  To maintain sterility during patient use, antimicrobial preservatives generally are included in ophthalmic formulations.
  • 6. The preservatives used in ophthalmic solutions/suspensions are  benzalkonium chloride , 0.004-0.01%;  benzethonium chloride, 0.01%;  chlorobutanol, 0.5%;  phenylmercuric acetate, 0.004%;  phenylmercuric nitrite, 0.004%;  thimerosal, 0.005-0.01%
  • 7.  Isotonic solution: a solution that has the same salt concentration as the normal cells of the body and the blood.  Hypotonic, solutions with a lower osmotic pressure than body fluids or a 0.9% sodium chloride solution are commonly referred to as hypotonic.  Hypertonic, solutions have a greater osmotic pressure are termed hypertonic.
  • 8.  Boric acid has a molecular weight of 61.8, and thus 61.8 g in 1000 g of water should produce a freezing point of -1.86C. therefore: 1.86(C )/0.52(C )=61.8 (g)/x(g) X=17.3 g  17.3 g of boric acid in 1000g of water theoretically should produce a solution isosmotic with tears and blood.
  • 9. The aims for adjusting the pH of an ophthalmic preparation:  for greater comfort to the eye;  to render the formulation more stable;  to enhance the aqueous solubility of the drug;  to enhance the drug’s bioavailability;  to maximize preservative efficacy.
  • 10.  The pH of normal tears is considered to be about 7.4.  For maximum comfort, an ophthalmic solution should have the same pH as the lacrimal fluid.  A compromise pH is generally selected for solution and maintained by buffers to permit the greatest activity while maintaining stability.
  • 11.  Viscosity for ophthalmic solutions is considered optimal in the range of 15 to 25 cps.  In the preparation of ophthalmic solutions, a suitable grade of methylcellulose or other thickening agent (hydroxypropyl methylcellulose, polyvinyl alcohol) is frequently added to increase the viscosity.
  • 12. There are physiologic factors which can affect a drug’s ocular bioavailability, including  protein binding,  drug metabolism  lacrimal drainage
  • 13. Soft plastic containers 2, 2.5, 5, 10, 15, 30 mL
  • 14.  wash hands thoroughly  inspect for color and clarity  be shaken thoroughly prior to administration (ophthalmic suspensions)  not to touch the dropper to the eye, eyelid or any other surface