DepoFoam® Multivesicular Liposomes for the Sustained Release of Macromolecules

Dadey, Eric J.

doi:10.3109/9781420045260-18

Cited by 7 publications

(4 citation statements)

References 12 publications

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“…Aside from liposome bupivacaine, DepoFoam technology has been in use for >15 years in prolonged-release formulations of medications such as cytarabine (DepoCyt ® , Pacira Pharmaceuticals, Inc.) and morphine (DepoDur ® , Pacira Pharmaceuticals, Inc.). 10 , 13 , 14 The DepoFoam-based formulations of cytarabine, morphine, and bupivacaine have each been shown to have safety profiles that are similar to standard formulations of the active drug. 9 , 22 – 24 …”

Section: Discussionmentioning

confidence: 99%

“…Liposome bupivacaine utilizes DepoFoam ® technology (Pacira Pharmaceuticals, Inc.), which consists of an aqueous suspension of multivesicular liposomes organized in a non-concentric, honeycomb-like structure. 10 , 11 The liposomes are made up of multiple drug-containing vesicles. Each vesicle is surrounded by a lipid bilayer that provides mechanical stability and allows for controlled release of drug over several days.…”

Section: Introductionmentioning

confidence: 99%

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The safety of liposome bupivacaine following various routes of administration in animals

Joshi¹,

Patou²,

Kharitonov³

2015

JPR

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BackgroundThis report presents results from four preclinical studies evaluating safety and pharmacokinetics (PKs) of liposome bupivacaine following intravascular (intravenous [IV], intra-arterial [IA]), epidural, and intrathecal administration in dogs.MethodsIntravascular administration was initially tested in a pilot study to determine maximum tolerated doses, and then in an expanded study of systemic adverse effects and PKs. An epidural study compared properties of liposome bupivacaine alone and in combination with lidocaine/epinephrine vs bupivacaine HCl. Another study assessed effects after intrathecal administration.ResultsIn the initial intravascular studies, maximum doses at which no meaningful adverse events were observed with liposome bupivacaine were higher than for bupivacaine HCl (4.5 mg/kg IV vs 0.75 mg/kg IV, and 1.5 mg/kg IA vs 0.1 mg/kg IA, respectively). In the expanded intravascular study, there was no mortality or changes in pathology; adverse clinical signs included convulsions, lying on side, and decreased muscle tone (all were transient). In the epidural study, liposome bupivacaine was well tolerated at doses up to the highest dose tested (40 mg), with no evidence of spinal cord damage and with less motor blockade than bupivacaine HCl 15 mg. Intrathecal administration of liposome bupivacaine 40 mg was not associated with meaningful safety concerns and resulted in less motor blockade than bupivacaine HCl 15 mg. PK analyses showed that maximum plasma bupivacaine levels following administration of liposome bupivacaine (4.5 mg/kg IV and 40 mg epidural) were similar to maximum plasma bupivacaine levels following a threefold lower dose of bupivacaine HCl (1.5 mg/kg IV and 15 mg epidural).ConclusionLiposome bupivacaine has a favorable safety profile compared with bupivacaine HCl when administered to dogs via intravascular, epidural, and intrathecal routes. This favorable safety profile is likely related to the liposome-bound nature of bupivacaine in the liposome bupivacaine formulation.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The safety of liposome bupivacaine following various routes of administration in animals

Joshi¹,

Patou²,

Kharitonov³

2015

JPR

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“…Types of liposomes include unilamella, multilamella and multivesicular forms, and their targeted delivery functions were improved from plain liposomes to stealth liposomes, targeting moiety-conjugated stealth liposomes and responsive drug-release liposomes. Applications of liposomal dosage forms are found in the delivery of antifungal drugs, nucleotide drugs and proteins [5].…”

Section: Conference Report | News and Analysismentioning

confidence: 99%

Conference Report: Pharmaceutical Development of Biologics: fundamentals, Challenges and Recent Advances

Mazzeo

Subbarao

et al. 2011

Therapeutic Delivery

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The 46th Arden Conference, held in West Point, NY, USA, March 2011, focused on development of protein therapeutics, comprising preformulation, formulation, manufacturing, advanced delivery systems, protein characterization/analysis, and regulatory landscape. The sessions of preformulation and formulation development consisted of nine lectures discussing protein stability implications and characterization during purification, freeze-drying and manufacturing. The session on advanced drug delivery encompassed two new sustained-release microsphere formulations (protein microencapsulation by annealing of premade porous PLGA microspheres and aqueous–aqueous emulsion for preformulating proteins to solvent-resistant particles), two transdermal insulins (patching after thermal ablation of skin and phase-transition hydrogel microneedle patch), and a responsible hydrogel system for intra-ear delivery. The sessions on analytical technologies and regulatory landscape both focused on challenges for biosimilars.

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“…[3][4][5][6] The lipid layers in DepoFoam are composed of biodegradable phospholipids, cholesterol, and triglycerides. 5,7,8 The rate of drug release can vary based on the characteristics of the lipid membrane components and the encapsulated aqueous phase, as well as the milieu in which DepoFoam is suspended. 5 One formulation of liposome bupivacaine (bupivacaine liposome injectable suspension [Exparel]; Pacira Pharmaceuticals, Inc, Parsippany, New Jersey), based on DepoFoam technology, was approved by the US Food and Drug Administration (FDA) in 2011.…”

mentioning

confidence: 99%

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks

Ilfeld

Viscusi

Hadžić

et al. 2015

Regional Anesthesia and Pain Medicine

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DepoFoam® Multivesicular Liposomes for the Sustained Release of Macromolecules

Cited by 7 publications

References 12 publications

The safety of liposome bupivacaine following various routes of administration in animals

The safety of liposome bupivacaine following various routes of administration in animals

Conference Report: Pharmaceutical Development of Biologics: fundamentals, Challenges and Recent Advances

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks

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