Development of Novel Oral Formulations Prepared <i>via</i> Hot Melt Extrusion for Targeted Delivery of Photosensitizer to the Colon

Cassidy, Corona M.; Tunney, Michael; Caldwell, Deborah L.; Andrews, Gavin; Donnelly, Ryan F.

doi:10.1111/j.1751-1097.2011.00915.x

Cited by 27 publications

(14 citation statements)

References 60 publications

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“…Cassidy et al . [207] reported a new strategy for delivery of PS to the colon which was called a ‘smart vehicle’. According to this strategy, the PS (MB or a cationic porphyrin) was encapsulated in a Eudragit® 25-based drug delivery system, via hot melt extrusion.…”

Section: Treatmentmentioning

confidence: 99%

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Clostridium difficileinfection: molecular pathogenesis and novel therapeutics

Rineh

Kelso

Vatansever

et al. 2014

Expert Review of Anti-infective Therapy

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The Gram-positive anaerobic bacterium Clostridium difficile produces toxins A and B, which can cause a spectrum of diseases from pseudomembranous colitis to C. difficile-associated diarrhea. A limited number of C. difficile strains also produce a binary toxin that exhibits ADP ribosyltransferase activity. Here, the structure and the mechanism of action of these toxins as well as their role in disease are reviewed. Nosocomial C. difficile infection is often contracted in hospital when patients treated with antibiotics suffer a disturbance in normal gut microflora. C. difficile spores can persist on dry, inanimate surface for months. Metronidazole and oral vancomycin are clinically used for treatment of C. difficile infection but clinical failure and concern about promotion of resistance are motivating the search for novel non-antibiotic therapeutics. Methods for controlling both toxins and spores, replacing gut microflora by probiotics or fecal transplant, and killing bacteria in the anaerobic gut by photodynamic therapy are discussed.

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Section: Treatmentmentioning

confidence: 99%

“…There was also addition of tetrachlorodecaoxide (TCDO) that released oxygen in the colon. Although this strategy looks promising in vitro , it is far from being clinically used and further in vivo examination in animal models would be needed [207]. …”

Section: Treatmentmentioning

confidence: 99%

Clostridium difficileinfection: molecular pathogenesis and novel therapeutics

Rineh

Kelso

Vatansever

et al. 2014

Expert Review of Anti-infective Therapy

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“…The results of this study showed that no drug was released in the acidic medium. The authors demonstrated with these formulations that photosensitizer release could potentially be targeted to the colon, and therefore, the pathogen resident there could be killed by PACT (74).…”

Section: Targeted Drug Deliverymentioning

confidence: 99%

“…Cassidy et al (74) achieved the targeted drug delivery of a photosensitizer to the colon via a formulation prepared using HME. The authors used Eudragit® S 100 as a polymer, and the formulation composed of the drug, polymer, photosensitizer, and the plasticizer, TEC, was extruded using a TSE.…”

Section: Targeted Drug Deliverymentioning

confidence: 99%

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation

2015

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Abstract. Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently used belong to the biopharmaceutical classification system II (BCS class II), which are characterized as poorly water-soluble compounds and result in formulations with low bioavailability. Therefore, there is a critical need for the pharmaceutical industry to develop formulations that will enhance the solubility and ultimately the bioavailability of these compounds. HME technology also offers an opportunity to earn intellectual property, which is evident from an increasing number of patents and publications that have included it as a novel pharmaceutical formulation technology over the past decades. This review had a threefold objective. First, it sought to provide an overview of HME principles and present detailed engineered extrusion equipment designs. Second, it included a number of published reports on the application of HME techniques that covered the fields of solid dispersions, microencapsulation, taste masking, targeted drug delivery systems, sustained release, films, nanotechnology, floating drug delivery systems, implants, and continuous manufacturing using the wet granulation process. Lastly, this review discussed the importance of using the quality by design approach in drug development, evaluated the process analytical technology used in pharmaceutical HME monitoring and control, discussed techniques used in HME, and emphasized the potential for monitoring and controlling hot-melt technology.

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“…HME-based techniques have identified newer applications of colon-specific targeting. An Eudragit ® -based HME delivery system based on a photosensitizer was developed as a novel treatment option for curing serious infections of clinical significance caused by multidrug-resistant organisms such as Enterococcus faecalis and Bacteroides fragilis (Cassidy et al 2011). …”

Section: Targeted Release Systemsmentioning

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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Development of Novel Oral Formulations Prepared via Hot Melt Extrusion for Targeted Delivery of Photosensitizer to the Colon

Cited by 27 publications

References 60 publications

Clostridium difficileinfection: molecular pathogenesis and novel therapeutics

Clostridium difficileinfection: molecular pathogenesis and novel therapeutics

Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation

Melt Extrusion in Drug Delivery: Three Decades of Progress

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