Study of Anionic and Cationic Surfactants in a Hydrophilic Ointment Base I. The Screening Program

Patel, Kanu C.; Banker, Gilbert S.; DeKay, H. George

doi:10.1002/jps.2600500404

Cited by 3 publications

(1 citation statement)

References 4 publications

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“…Upon addition of bulk repaglinide to the dissolution medium, the powder did not wet but remained floating at the air-liquid interface. Incorporation of a wetting agent, SDS, [29][30][31] into the URF formulation (URF-A) resulted in rapid wetting of the powder upon addition to the dissolution medium, with the formulation rapidly sinking into the medium and wetting upon initiation of the dissolution test. The level of SDS studied during dissolution was~2.5 mg SDS in 900 mL of dissolution medium, which is below the critical micelle concentration of SDS.…”

Section: Dissolution Results (Sink Conditions)mentioning

confidence: 99%

Rapidly dissolving repaglinide powders produced by the ultra-rapid freezing process

et al. 2007

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The objective of the study was to produce rapidly dissolving formulations of the poorly water-soluble drug repaglinide using an innovative new technology, ultra-rapid freezing (URF), and to investigate the influence of excipient type on repaglinide stability. Repaglinide compositions containing different types and levels of excipients and different drug potencies (50%-86%) were produced by the URF technology. Repaglinide/excipient solutions were frozen on a cryogenic substrate, collected, and lyophilized to form a dry powder. Surfactants, including sodium dodecyl sulfate, and alkalizing agents such as diethanolamine (DEA) and tromethamine (TRIS) were incorporated into the compositions. Forced degradation of repaglinide was conducted under stressed conditions (eg, elevated temperature, exposure to peroxide) to determine the stability of the drug in such environments. The solubility of repaglinide increased as a function of increasing pH; therefore, incorporation of an alkalizing agent into the URF formulations increased the drug's solubility. Drug instability resulted when the drug was exposed to pH values above 9.0. URF formulations containing alkalizing agents showed no degradation or spontaneous recrystallization in the formulation, indicating that increased stability was afforded by processing. URF processing created nanostructured drug/excipient particles with higher dissolution rates than were achieved for unprocessed drug. Alkalizing agents such as TRIS and DEA, present at levels of 25% to 33% wt/wt in the formulations, did not cause degradation of the drug when processed using URF. URF processing, therefore, yielded fast-dissolving formulations that were physically and chemically stable, resistant to alkali degradation or spontaneous recrystallization in the formulation.

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Section: Dissolution Results (Sink Conditions)mentioning

confidence: 99%

Rapidly dissolving repaglinide powders produced by the ultra-rapid freezing process

et al. 2007

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Die Anwendung radioaktiver Isotope in der pharmazeutischen Forschung

Schulte

Mleinek

1964

Fortschritte Der Arzneimittelforschung / Progress in Drug Research / Progrès Des Recherches Pharmaceutiques

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Final Report on the Safety Assessment of TEA-Lauryl Sulfate

1982

Journal of the American College of Toxicology

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TEA-Lauryl Sulfate is the triethanolamine salt of lauryl sulfuric acid. It is used in cosmetics as a detergent, a stabilizer and a solubilizer. The ingredient was moderately to slightly toxic in acute oral studies with rats; reported LD50s ranged from 0.27 to > 1.95 g/kg. Animal studies showed that the surfactant is a significant skin and eye irritant. In clinical studies, shampoos containing 10.5% TEA-Lauryl Sulfate caused no irritation under semioccluded conditions. Diluted shampoos containing 0.15-7.5% of the surfactant caused human skin reactions ranging from no irritation to moderate irritation. This skin irritation phenomenon is observed with most detergents. Undiluted shampoos containing 10.5% TEA-Lauryl Sulfate showed low potential for eliciting human skin sensitization. No evidence of photosensitization was observed in subjects exposed to solutions containing up to 0.42% TEA-Lauryl Sulfate. On the basis of the available animal and human data, the Panel concludes that TEA-Lauryl Sulfate can be used without significant irritation at a final concentration not exceeding 10.5%. Greater concentrations may cause irritation, especially if allowed to contact the skin for significant periods of time.

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Study of Anionic and Cationic Surfactants in a Hydrophilic Ointment Base I. The Screening Program

Cited by 3 publications

References 4 publications

Rapidly dissolving repaglinide powders produced by the ultra-rapid freezing process

Rapidly dissolving repaglinide powders produced by the ultra-rapid freezing process

Die Anwendung radioaktiver Isotope in der pharmazeutischen Forschung

Final Report on the Safety Assessment of TEA-Lauryl Sulfate

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