Patient Compliance With Use of Topical Ophthalmic Corticosteroid Suspensions

Apt, Leonard; Henrick, Andrew; Silverman, Lawrence M.

doi:10.1016/0002-9394(79)90145-4

Cited by 42 publications

(16 citation statements)

References 2 publications

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“…Apt et al determined that only 37 of 100 patients actually shook a dropper bottle prior to administering a dose of an ophthalmic suspension to the eyes of a manikin, in spite of clear label directions instructing that the product should be shaken 3. The authors calculated that those who did not shake the product would have administered 29% or less of the target concentration for the four corticosteroid suspensions tested.…”

Section: Discussionmentioning

confidence: 99%

“…A “no-shake” formulation is potentially advantageous over formulations that require shaking for the simple reason that patients’ shaking behavior is a major source of variability in the amount of drug dosed. Apt et al reported that nearly two-thirds of patients did not shake their ophthalmic corticosteroid suspensions before administering a dose, despite the instructions to shake that were clearly marked on the label 3. For those patients who do shake the product, it is normally not possible to determine whether the shaking is adequate in intensity and/or duration to render the product uniform because the bottles containing ophthalmic products are typically opaque.…”

Section: Introductionmentioning

confidence: 99%

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Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%)

Marlowe

Davio

2013

OPTH

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IntroductionLoteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators.MethodsDrug concentrations of LE ophthalmic gel, Pred Forte, and a generic prednisolone acetate suspension were determined following simulated dosing – consisting of 2 drops, expressed four times daily for 2 weeks, with bottles that were shaken or not shaken immediately prior to expressing the drops. Drug concentrations were determined using a reverse-phase high-performance liquid chromatography (HPLC) method and reported as a percentage of the declared (labeled) concentration. Comparative kinetics of drug particle sedimentation were also determined for each formulation, using dispersion analysis under gravity.ResultsMean drug concentrations in drops of all three formulations were within a few percentage points of the declared concentration when the bottles were shaken for 5 seconds prior to dispensing. Only LE ophthalmic gel showed consistent and on-target concentrations when the bottles were unshaken prior to dispensing, with a mean (standard deviation [SD]) percent declared concentration of 102% (1.92%) over the 2-week dosing regimen. Drug concentrations for the branded and generic prednisolone acetate suspensions following expression from unshaken bottles were highly variable (overall relative SDs of 16.8% and 20.3%, respectively), with mean concentrations for both falling significantly below the declared concentration for drops expressed at the beginning of the 2-week dosing regimen and significantly above the declared concentration for drops expressed near the end of the dosing regimen. Dispersion analysis at 120× g showed no drug particle sedimentation for LE ophthalmic gel over the 24-hour testing period, whereas the prednisolone acetate suspensions settled in less than 6 hours.ConclusionLE ophthalmic gel 0.5% provided consistent dose uniformity at the declared concentration whether or not the bottle was shaken prior to dispensing, whereas Pred Forte® and the generic prednisolone acetate required shaking to provide consistent drug concentrations. LE ophthalmic gel may be beneficial to patients because it eliminates the potential impact on the clinical response of both under- and overdosing.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%)

Marlowe

Davio

2013

OPTH

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“…Lipophilic steroid preparations such as prednisolone acetate and dexametha¬ sone alcohol are more effective than water-soluble steroid derivatives but require thorough shaking and fre¬ quent administration to achieve max¬ imal intraocular delivery.1·2 Compli¬ ance with this regimen can be difficult for even the most cooperative patients. 3 Collagen corneal shields have re¬ cently been investigated as a vehicle for enhancing topical antibiotic delivery.47 Collagen shields are biode¬ gradable contact lens-shaped films made of porcine scierai collagen. The shields dissolve over a 12-to 72-hour period after placement on the eye, de¬ pending in part on the degree of colla¬ gen cross-linking induced at the time of manufacture.…”

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confidence: 99%

Collagen Shield Enhancement of Topical Dexamethasone Penetration

Hwang¹

1989

Arch Ophthalmol

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“…Drugs in suspension have the added disadvantage of poor patient compliance because they need to be resuspended before each use by shaking. 86,87 Cyclodextrins are used to solubilize complex drugs that are poorly soluble, unstable, or difficult to formulate. The cyclodextrin-drug complex improves wettability, dissolution, solubility, and stability in solution and preserves the intrinsic ability of the drug to penetrate biologic membranes.…”

Section: Improving Drug Absorption After Topical Therapy Drug Formulamentioning

confidence: 99%

Barriers to Glaucoma Drug Delivery

Ghate

Edelhauser

2008

Journal of Glaucoma

128

100

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Topical medications remain the mainstay of glaucoma treatment. This review will aim to cover the pharmacokinetics of topically applied drops, the ocular barriers to drug delivery, and the role of ophthalmic drug formulation in enhancing drug delivery to the target tissue while minimizing side effects and increasing patient compliance. Recent advances in surgical techniques, therapeutic approaches, and material sciences have produced exciting new therapies for ocular diseases. The development of new vehicles and drug formulations that require less patient compliance is also discussed, as are the routes of drug delivery for neuroprotection.

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Patient Compliance With Use of Topical Ophthalmic Corticosteroid Suspensions

Cited by 42 publications

References 2 publications

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%)

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%)

Collagen Shield Enhancement of Topical Dexamethasone Penetration

Barriers to Glaucoma Drug Delivery

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