Ethanol effects on drug release from Verapamil Meltrex®, an innovative melt extruded formulation

Roth, Wyatt J.; Setnik, Beatrice; Zietsch, M.; Burst, A.; Breitenbach, Jörg; Sellers, Edward M.; Brennan, Desmond

doi:10.1016/j.ijpharm.2008.09.052

Cited by 38 publications

(20 citation statements)

References 5 publications

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“…Acetate buffer of pH 5 containing 40% methanol was selected based on solubility data. Cosolvents at relatively high concentrations could be used as release media in drug release research (Shah et al, 2006;Roberts et al, 2007;Roth et al, 2009;Gulbake et al, 2010). The release profile of oxybenzone from F test is shown in Figure 4.…”

Section: In Vitro Drug Release and Release Stability Studymentioning

confidence: 99%

Formulation of wax oxybenzone microparticles using a factorial approach

Gomaa

Darwish

Boraei

et al. 2010

Journal of Microencapsulation

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Oxybenzone wax microparticles (MPs) were prepared by the hydrophobic congealable disperse phase method. The formulation of oxybenzone-loaded MPs was optimized using a 2⁴ experimental design. Factorial analysis indicated that the main MP characteristics were influenced by initial drug loading, emulsification speed, emulsifier concentration and hydrophilic-lipophilic balance. MPs were spherical with 50.5–88.1 μm size range, 17.8–38.9 drug content in mg/100 mg MPs and 33.1–87.2% oxybenzone release in 1 h. A wide range of sunscreen delivery systems suitable for different formulation purposes were generated which may contribute to the advanced formulation of sunscreen products with improved performance.

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Section: In Vitro Drug Release and Release Stability Studymentioning

confidence: 99%

Formulation of wax oxybenzone microparticles using a factorial approach

Gomaa

Darwish

Boraei

et al. 2010

Journal of Microencapsulation

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“…Dissolution AIDD studies were performed on four commercially available extended release formulations of verapamil 240 mg strength at 5, 10, 20 and 40% ethanol concentration (Roth et al 2009). The dissolution for this product uses 900 mL of pH 6.8 phosphate buffer dissolution media in USP Apparatus II and run for 8-10 h. Results of the testing show similar release rates in the 4 alcohol media compared to the control without alcohol for verapamil Meltrex formulation.…”

Section: Ethanol Effects On Verapamil Meltrexmentioning

confidence: 99%

A review of in vivo and in vitro aspects of alcohol-induced dose dumping

D’Souza

Mayock

Salt³

2017

AAPS Open

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This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner that releases drug in a tailored or delayed fashion. Awareness of AIDD has led to the withdrawal of a few marketed products by Regulatory Agencies, and black box warnings on others. Since then, significant effort has focused on proving the robustness of a formulation when co-ingested with alcohol. Patient risk is deemed to be low if the formulation and its performance is unimpaired by the presence of 0-40% alcohol under in vivo and in vitro conditions.

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“…Similar to Kaletra ® , Meltrex ® technology has also been used for designing drug products for Ritonavir (Norvir ® ), Ibuprofen (Klueglich et al 2005) and Verapamil tartrate (Isoptin ® SR) (Roth et al 2009), with aims of stabilizing the drug or providing Fig. 1.13 Dissolution profiles of Sporanox ® ( ), HPMC extrudate ( ), Eudragit ® E100 extrudate ( ), and Eudragit ® E100-PVPVA64 extrudate (•) in capsules containing 100 mg itraconazole in SGF sp .…”

Section: Clinical and Therapeutic Potentialmentioning

confidence: 99%

Melt Extrusion in Drug Delivery: Three Decades of Progress

Shah

Repka

2013

AAPS Advances in the Pharmaceutical Sciences Series

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This chapter appraises the role of melt extrusion as a solubilization and bioavailability enhancement technique. The introductory chapter highlights major aspects of hot melt extrusion (HME) technology as applied in the pharmaceutical industry, particularly processing techniques, material considerations, recent innovative applications of melt extrusion in drug delivery system design, and a review of current HME-based formulations (marketed or under commercial development). The chapter also focuses on key development aspects of HME processes, such as material sparing screening approaches, process formulation relationships, and stability evaluation of prototype formulations, which emphasize the clinical and biological significance of this technique. In addition, it displays the journey and evolution of this important processing technology into an established pharmaceutical manufacturing platform. The chapter describes several case studies wherein melt extrusion has been utilized to develop commercial drug products.Early-stage development in melt extrusion encompasses various critically interdependent areas involving process considerations, stability assessment of prototype formulations, and performance evaluation (with respect to intended applications) of prototype formulations. Processing ConsiderationsProcessing considerations is a rather broad terminology covering material properties, instrument considerations, and process-formulation interplay. Systematic research over the last couple of decades has revealed that critical product quality attributes are directly dependent on both "formulation" and the "process" employed. It is important to note that the interplay between these determines the finished product attributes. Material PropertiesAll of the materials used in melt extrusion (drugs, carriers, processing aids, release modifiers, etc.) should meet certain minimal pharmaceutical criteria, which

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Ethanol effects on drug release from Verapamil Meltrex®, an innovative melt extruded formulation

Cited by 38 publications

References 5 publications

Formulation of wax oxybenzone microparticles using a factorial approach

Formulation of wax oxybenzone microparticles using a factorial approach

A review of in vivo and in vitro aspects of alcohol-induced dose dumping

Melt Extrusion in Drug Delivery: Three Decades of Progress

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