Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group

被引：40

作者：

Bauer, Andrea ^{[1
]}

Berben, Philippe ^{[2
]}

Chakravarthi, Sudhir S. ^{[3
]}

Chattorraj, Sayantan ^{[4
]}

Garg, Ashish ^{[5
]}

Gourdon, Betty ^{[6
]}

Heimbach, Tycho ^{[7
]}

Huang, Ye ^{[8
]}

Morrison, Christopher ^{[4
]}

Mundhra, Deepak ^{[4
]}

Palaparthy, Ramesh ^{[9
]}

Saha, Pratik ^{[4
]}

Siemons, Maxime ^{[10
]}

Shaik, Naveed A. ^{[9
]}

Shi, Yi ^{[8
]}

Shum, Sara ^{[11
]}

Thakral, Naveen K. ^{[12
]}

Urva, Shweta ^{[5
]}

Vargo, Ryan ^{[7
]}

Koganti, Venkat R. ^{[3
]}

Barrett, Stephanie E. ^{[7
]}

机构：

[1] Sunov Pharmaceut, Marlborough, MA 01752 USA

[2] UCB Pharm SA, Braine LAlleud, Belgium

[3] Bristol Myers Squibb, New Brunswick, NJ 08901 USA

[4] GlaxoSmithKline, Collegeville, PA 19426 USA

[5] Eli Lilly & Co, Indianapolis, IN USA

[6] Biogen, Cambridge, MA 02142 USA

[7] Merck & Co Inc, Rahway, NJ 07065 USA

[8] AbbVie Inc, N Chicago, IL 60064 USA

[9] Gilead Sci, Foster City, CA 94404 USA

[10] Div Janssen Pharmaceut NV, Janssen R&D, Beerse, Belgium

[11] Takeda Dev Ctr Amer Inc, Cambridge, MA 02139 USA

[12] Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA

来源：

PHARMACEUTICAL RESEARCH | 2023年 / 40卷 / 07期

关键词：

drug product development; formulation development; long-acting injectables; pre-clinical assessments; quality attributes; IN-VIVO CORRELATION; VITRO DRUG-RELEASE; PALIPERIDONE PALMITATE; PLGA MICROSPHERES; PHARMACOKINETICS; FORMULATION; DELIVERY; POLYMERS; CHALLENGES; BIOPHARMACEUTICALS;

D O I：

10.1007/s11095-022-03391-y

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

Long-acting injectable (LAI) formulations can provide several advantages over the more traditional oral formulation as drug product opportunities. LAI formulations can achieve sustained drug release for extended periods of time, which results in less frequent dosing requirements leading to higher patient adherence and more optimal therapeutic outcomes. This review article will provide an industry perspective on the development and associated challenges of long-acting injectable formulations. The LAIs described herein include polymer-based formulations, oil-based formulations, and crystalline drug suspensions. The review discusses manufacturing processes, including quality controls, considerations of the Active Pharmaceutical Ingredient (API), biopharmaceutical properties and clinical requirements pertaining to LAI technology selection, and characterization of LAIs through in vitro, in vivo and in silico approaches. Lastly, the article includes a discussion around the current lack of suitable compendial and biorelevant in vitro models for the evaluation of LAIs and its subsequent impact on LAI product development and approval.

引用

页码：1601 / 1631

页数：31

共 131 条

[1] Dissolution Testing for Generic Drugs: An FDA Perspective [J].