A Comparison of Wax Matrix and Microencapsulated Potassium Chloride in Relation to Upper Gastrointestinal Illness Requiring Hospitalization

Jick, Hershel; Jick, Susan S.; Walker, Alexander M.; Stergachis, Andy

doi:10.1002/j.1875-9114.1989.tb04126.x

Cited by 12 publications

(3 citation statements)

References 8 publications

(2 reference statements)

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“…phase separation, solvent evaporation, and interfacial polymerization methods, to control the bioavailability (Sjovall et al 1984, Sanders et al 1984, minimize sideeffects (Malfertheiner et al 1988, Jick et al 1989 or improve the physicochemical properties of drugs (Singh andRobinson 1988, Sugimori et al 1990). T h e present authors previously devised a novel method for preparing spherical microcapsules (i.e.…”

Section: Introductionmentioning

confidence: 99%

Role of the solvent-diffusion-rate modifier in a new emulsion solvent diffusion method for preparation of ketoprofen microspheres

Kawashima

Iwamoto

Niwa

et al. 1993

Journal of Microencapsulation

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A new emulsion solvent diffusion method to prepare the microspheres of ketoprofen with an acrylic polymer was developed by utilizing sugar esters as solvent diffusion modifiers. The microspheres were produced via transient o/w emulsion droplets of the polymer, which was formed by the interaction of drug and water-miscible organic solvent, e.g. ethanol. The solvent consisting in oil droplets diffused into the outer aqueous medium. In the droplets, ethanol interacted with ketoprofen via hydrogen bonding between -OH group of ethanol and both -COOH and = CO groups of ketoprofen. These hydrogen bonds made ethanol solution strongly hydrophobic. The sugar ester added in the ethanol could inhibit such intermolecular interaction between ethanol and the = CO group of ketoprofen. Modulation in the binding force of ketoprofen-ethanol by the sugar ester contributed to achieving a desirable initial ethanol diffusion rate from the oil droplets for the formation of ketoprofen microspheres with high yield (> 85 per cent) and drug entrapment ratio (> 90 per cent).

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Section: Introductionmentioning

confidence: 99%

Role of the solvent-diffusion-rate modifier in a new emulsion solvent diffusion method for preparation of ketoprofen microspheres

Kawashima

Iwamoto

Niwa

et al. 1993

Journal of Microencapsulation

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“…Policy trials10 randomize clusters of patients – for example, by physicians10 or facilities 11,12. These can be structured to be of sufficiently low risk and complexity that individual patient consent may be waived 13.…”

Section: Introductionmentioning

confidence: 99%

Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

McCarren¹,

Twedt²,

Mansuri³

et al. 2014

TCRM

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PurposeMinimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to “favor” a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design.Subjects and methodsAgreeable providers were randomized to “favor” either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate.ResultsAll four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the “favor hydrochlorothiazide” group, there was 99% adherence to that strategy. In the “favor chlorthalidone” group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25–50 mg/day) and 100% for chlorthalidone (12.5–25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy.ConclusionProviders prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change in non-research clinicians. Waiver of patient consent can broaden the representation of patients, providers, and settings.

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“…Although cluster randomization has been applied to the study of prescription drugs—as in comparing two different forms of potassium supplements by randomizing pharmacies to dispense one or another formulation—the methodology has not been widely used for this purpose 6 . To our knowledge, the reasons for this have not been addressed systematically.…”

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confidence: 99%

Comparing Drug Effectiveness at Health Plans: The Ethics of Cluster Randomized Trials

Sabin¹,

Mazor²,

Meterko³

et al. 2008

Hastings Center Report

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A Comparison of Wax Matrix and Microencapsulated Potassium Chloride in Relation to Upper Gastrointestinal Illness Requiring Hospitalization

Cited by 12 publications

References 8 publications

Role of the solvent-diffusion-rate modifier in a new emulsion solvent diffusion method for preparation of ketoprofen microspheres

Role of the solvent-diffusion-rate modifier in a new emulsion solvent diffusion method for preparation of ketoprofen microspheres

Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

Comparing Drug Effectiveness at Health Plans: The Ethics of Cluster Randomized Trials

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