A Comprehensive Map of FDA-Approved Pharmaceutical Products

Zhong, Haiyang; Chan, Ging; Y, Hu; Hao, Hu; Ouyang, Defang

doi:10.3390/pharmaceutics10040263

Cited by 216 publications

(127 citation statements)

References 57 publications

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“…Injectable PLGA microparticles have been in use in clinics for over 30 years and their clinical success is unquestioned. With four new medicinal products approved in the last 5 years (pasireotide pamoate, Signifor Lar ® ; triptorelin pamoate, Triptodur™; triamcinolone acetonide, Zilretta ® ; and exenatide, Bydureon Bcise ® ) (Jain et al 2016;Zhong et al 2018;Schoubben et al 2019), PLGA microparticles seem to have a promising future. Most probably, PLGA microparticulate products will continue to be investigated and marketed for the delivery of peptides and, hopefully, proteins that require parenteral administration.…”

Section: Resultsmentioning

confidence: 99%

“…By considering also different PLA/PLGA formulations, such as preformed and in situ forming depots, more than 35 products have been successfully developed (Tice 2017). A list of the medicinal products based on PLA/PLGA microparticles can be found in recent reviews (Wischke and Schwendeman 2012;Jain et al 2016;Zhong et al 2018;Schoubben et al 2019).…”

Section: From Sutures To Microspheresmentioning

confidence: 99%

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Poly(lactic acid)/poly(lactic-co-glycolic acid)-based microparticles: an overview

Blasi

2019

J. Pharm. Investig.

154

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Background Poly(glycolic acid), poly(lactic acid) and poly(lactic-co-glycolic acid) were approved by the United States Food and Drug Administration (FDA) in the 1970s as materials for the manufacturing of bioresorbable surgical sutures, but soon became the reference materials for the preparation of sustained release formulations, especially injectable microparticles. Since the 1986 approval of Decapeptyl ® SR, the first product based on PLGA microspheres, more than 15 such products have been approved for clinical use. Area covered This article highlights the key steps that brought to the development of injectable poly(lactic acid)/poly(lacticco-glycolic acid) microparticles for the sustained release of active pharmaceutical ingredients. After a brief history of some pioneering works that opened the field of controlled drug delivery, the key steps that led to the development of these polymers and the approval of the first microparticle-based medicinal products are reviewed. Finally, the general characteristics of these polymers are described and the classical preparation method is explained. Expert opinion Poly(lactic acid)/poly(lactic-co-glycolic acid) microparticles are among the most successful drug delivery systems. The recent approval of new medicinal products based on PLGA microspheres is the proof that pharmaceutical companies have continued to exploit this drug delivery technology. The possible development of generics and the continuous discovery of therapeutic peptides will hopefully further the success of microsphere technology.

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Section: Resultsmentioning

confidence: 99%

Section: From Sutures To Microspheresmentioning

confidence: 99%

Poly(lactic acid)/poly(lactic-co-glycolic acid)-based microparticles: an overview

Blasi

2019

J. Pharm. Investig.

154

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“…[262] Abraxane, a paclitaxel loaded albumin-bound nanoparticles, was available in the market in 2005 and achieved great commercial success for the treatment of recurrent breast cancer. [264,265] Those successful applications confirmed the high potential in the development of proteinloaded nanomedicines. Global markets are projected to reach 177.6 billion $US by 2019.…”

Section: Discussionmentioning

confidence: 72%

Rational Design of Nanocarriers for Intracellular Protein Delivery

et al. 2019

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Protein/antibody therapeutics have exhibited the advantages of high specificity and activity even at an extremely low concentration compared to small molecule drugs. However, they are accompanied by unfavorable physicochemical properties such as fragile tertiary structure, large molecular size, and poor penetration of the membrane, and thus the clinical use of protein drugs is hindered by inefficient delivery of proteins into the host cells. To overcome the challenges associated with protein therapeutics and enhance their biopharmaceutical applications, various protein‐loaded nanocarriers with desired functions, such as lipid nanocapsules, polymeric nanoparticles, inorganic nanoparticles, and peptides, are developed. In this review, the different strategies for intracellular delivery of proteins are comprehensively summarized. Their designed routes, mechanisms of action, and potential therapeutics in live cells or in vivo are discussed in detail. Furthermore, the perspective on the new generation of delivery systems toward the emerging area of protein‐based therapeutics is presented as well.

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“…Such advances were the basis of the improvements in chemotherapy efficacy using liposomal formulations of doxorubicin (Doxil), which was introduced for the treatment of Kaposi's sarcoma in 1995. In addition, over 340 DDS have been approved by the FDA and employed clinically to date (Table 3 from Zhong et al, 2018), and it is clear that nanomaterial DDS have great potential for the targeted delivery of drugs. However, passive targeting is only useful for targeting very specific organs such as tumors (Torchilin, 2014), and even in those cases, some regions of tumors exhibit variations in microvascular permeability that diminish the efficacy of passive targeting.…”

Section: Introductionmentioning

confidence: 99%

Targeted Drug Delivery via the Use of ECM-Mimetic Materials

Hwang

Sullivan

Kiick

2020

Front. Bioeng. Biotechnol.

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The use of drug delivery vehicles to improve the efficacy of drugs and to target their action at effective concentrations over desired periods of time has been an active topic of research and clinical investigation for decades. Both synthetic and natural drug delivery materials have facilitated locally controlled as well as targeted drug delivery. Extracellular matrix (ECM) molecules have generated widespread interest as drug delivery materials owing to the various biological functions of ECM. Hydrogels created using ECM molecules can provide not only biochemical and structural support to cells, but also spatial and temporal control over the release of therapeutic agents, including small molecules, biomacromolecules, and cells. In addition, the modification of drug delivery carriers with ECM fragments used as cell-binding ligands has facilitated celltargeted delivery and improved the therapeutic efficiency of drugs through interaction with highly expressed cellular receptors for ECM. The combination of ECM-derived hydrogels and ECM-derived ligand approaches shows synergistic effects, leading to a great promise for the delivery of intracellular drugs, which require specific endocytic pathways for maximal effectiveness. In this review, we provide an overview of cellular receptors that interact with ECM molecules and discuss examples of selected ECM components that have been applied for drug delivery in both local and systemic platforms. Finally, we highlight the potential impacts of utilizing the interaction between ECM components and cellular receptors for intracellular delivery, particularly in tissue regeneration applications.

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A Comprehensive Map of FDA-Approved Pharmaceutical Products

Cited by 216 publications

References 57 publications

Poly(lactic acid)/poly(lactic-co-glycolic acid)-based microparticles: an overview

Poly(lactic acid)/poly(lactic-co-glycolic acid)-based microparticles: an overview

Rational Design of Nanocarriers for Intracellular Protein Delivery

Targeted Drug Delivery via the Use of ECM-Mimetic Materials

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