Abstract:
INTRODUCTION:Use of pre-filled syringes as both a packaging and delivery system for pharmaceutical drug products is accelerating. Pre-filled syringes must meet the quality and suitability for use requirements for both systems, including compatibility with the drug product. Relevant incompatibilities between pre-filled syringes and drug products include the safety of syringe-based leachables that accumulate in drug products and the ability of leachables to interact with the drug product's ingredients as such interactions can affect safety, efficacy, stability and physical viability. AREAS COVERED:Relevant suitability considerations for pre-filled syringes are discussed herein and specific examples of suitability for use issues for pre-filled syringes are cited, focusing on extractables associated with pre-filled syringes and leachables derived from such syringes. Aspects considered include the toxicological impact of leachables, their ability to alter the efficacy of drug products and to produce other undesirable outcomes such as aggregation and immunogenic responses. EXPERT OPINION:Materials used in pre-filled syringes and the conditions of use minimize the traditional safety risk associated with leachables. However, drug products that use pre-filled syringes are prone to non-traditional interactions such as disruption of protein conformation, leading to potential efficacy, safety and quality issues. In order to qualify pre-filled syringes for use, the traditional approach of measuring extractables and leachables and inferring their effect must be augmented by rigorous compatibility testing. Research into the fundamental relationship between leachables and drug substances will be necessary so the more time- and cost-efficient 'measure and infer' approach can be widely implemented.
journal_name
Expert Opin Drug Delivjournal_title
Expert opinion on drug deliveryauthors
Jenke DRdoi
10.1517/17425247.2014.928281subject
Has Abstractpub_date
2014-10-01 00:00:00pages
1591-600issue
10eissn
1742-5247issn
1744-7593journal_volume
11pub_type
杂志文章,评审abstract:INTRODUCTION:Many drug candidates with high therapeutic efficacy have low water solubility, which limits the administration and transport across physiological barriers, for example, the tumor tissue barrier. Therefore, strategies are needed to permeabilize the physiological barriers safely so that hydrophobic drugs may...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2015.1021681
更新日期:2015-01-01 00:00:00
abstract::Background: Atopic dermatitis is a chronic inflammatory skin disease that remarkably affects the quality-of-life of patients. Chamomile oil is used to treat skin inflammations. We evaluated the efficacy of chamomile oil and nanoemulgel formulations as a natural alternative therapeutic option for atopic dermatitis.Rese...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1080/17425247.2020.1699054
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:A major problem in ocular therapeutics with classical formulations is the maintenance of an effective drug concentration at the site of action for a long period of time. Enhancement of ocular bioavailability with increased dose penetration and longer retention time at desired sites can be achieved by recen...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2012.681775
更新日期:2012-06-01 00:00:00
abstract:INTRODUCTION:Recent developments in ultrasound imaging and ultrasound contrast agents (UCAs) improved diagnostic confidence in echography and set into motion their combined use as a tool for drug delivery and therapeutic monitoring. Non-invasive, precise and targeted delivery of drug molecules to pathological tissues b...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2017.1266328
更新日期:2017-09-01 00:00:00
abstract:AIM:Spacer devices are inhalation aids of varying dimension and complexity, specifically designed to overcome problems with the use of pressurised metered dose inhalers (pMDIs). The aim of this review is to examine the current understanding about these inhalation devices and discuss their advantages and disadvantages. ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240802637862
更新日期:2009-01-01 00:00:00
abstract::With the advent of new, and often expensive, therapeutics designed for aerosol delivery to the lung, there is a need to improve the targeting and efficiency of their delivery. By controlling breathing patterns associated with inhaled aerosols, it has been shown that deposition in the lung can be both maximised and tar...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2.4.763
更新日期:2005-07-01 00:00:00
abstract:OBJECTIVES:To develop orodispersible films (ODF) based on hydrophobic polymers with higher stability to ordinary environmental humidity conditions without compromising their fast disintegration time. METHODS:A quality by design approach was applied to screen three different formulations each one based on a different h...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1080/17425247.2016.1218458
更新日期:2016-10-01 00:00:00
abstract:INTRODUCTION:Hepatocellular carcinoma (HCC) is one of the most common lethal malignancies. The prognosis is poor despite progress in early diagnosis. The initial treatment of choice is hepatic resection; unfortunately, not all patients are eligible for liver resection. Moreover, there are significant recurrences. Diffe...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2013.770733
更新日期:2013-05-01 00:00:00
abstract::Many agents used to treat cancer are toxic to normal tissues. Thus, treatments delivering drug specifically to tumour, while minimising exposure to normal tissue, may be advantageous over non-targeted treatments. The exquisite specificity of the immune system has been used successfully to help develop targeted antican...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.5.1.87
更新日期:2008-01-01 00:00:00
abstract::The treatment of oral and periodontal diseases and associated anomalies accounts for a significant proportion of the healthcare burden, with the manifestations of these conditions being functionally and psychologically debilitating. Growth factors are critical to the development, maturation, maintenance and repair of ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.3.5.647
更新日期:2006-09-01 00:00:00
abstract:INTRODUCTION:Oral delivery of therapeutic peptide hormones offers the promise of greater patient compliance when compared to parenteral administration routes. However, it is a huge challenge in the pharmaceutical field. Due to increasing demand for oral delivery of peptide hormones such as insulin, gonadotropin-releasi...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2016.1142526
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVES:This study focuses on the development of amlodipine bilayer buccal tablets of hydroxypropyl methylcellulose (HPMC) matrix system containing polyacrylate polymer (Carbopol(®))/β-cyclodextrin as the drug layer and ethylcellulose as the non-swellable backing layer, and their biointerfacial phenomena. METHODS:T...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2016.1154038
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:The utility of controlled and sustained release of drugs from polymeric systems, both bulk (hydrogels) and colloids (nanoparticles), is a key point that should be addressed. Unfortunately, classic delivery systems are essentially driven by diffusion, which is very quick due to the high concentration gradie...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2017.1285280
更新日期:2017-11-01 00:00:00
abstract::Nitric oxide (NO), the 1992 'Molecule of the Year', is the focus of immense medical and scientific exploration. Interest in NO has grown exponentially since the initial and relatively recent discovery that NO is the long sought after endothelial relaxing factor. There is intense research that is continuing to expose t...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240903196743
更新日期:2009-10-01 00:00:00
abstract::Among the strategies developed for drug delivery into the CNS, locally controlled drug release by the way of an implantable polymeric device has been developed in recent years. The first polymeric devices developed were macroscopic implants needing open surgery for implantation. Over the last few years, poly(lactide-c...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2.2.363
更新日期:2005-03-01 00:00:00
abstract:INTRODUCTION:Many new drug substances have low aqueous solubility which can cause poor bioavailability after oral administration. The application of solid dispersions is a useful method to increase the dissolution rate of these drugs and thereby improve their bioavailability. So far, several methods have been developed...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2011.598147
更新日期:2011-09-01 00:00:00
abstract:OBJECTIVES:Thermosensitive chitosan/glycerophosphate (C/GP) solutions exhibiting sol-gel transition around body temperature were prepared to develop a class of injectable hydrogel platforms for the imaging and loco-regional treatment of hepatocellular carcinoma (HCC). Indocyanine green (ICG) was loaded in the thermosen...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2015.1042452
更新日期:2015-01-01 00:00:00
abstract:INTRODUCTION:Transportation of the nutrients and other substances from the blood to the brain is selectively controlled by the brain capillary endothelial cells that form a restrictive barrier, so-called blood-brain barrier (BBB). Currently, there is no unimpeachable approach to overcome the BBB obstructiveness because...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2019.1614911
更新日期:2019-06-01 00:00:00
abstract::Introduction: Sativex® spray is clinically utilized to deliver delta9-tetrahydrocannabinol and cannabidiol to oral mucosa for systemic absorption. We challenge the consensus that the mechanism of absorption following the oro-mucosal application occurs via the buccal tissue. Areas covered: Correctness of the consensus ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2019.1653852
更新日期:2019-10-01 00:00:00
abstract::dl-Methylphenidate (MPH) remains the most widely used pharmacological agent in the treatment of attention-deficit/hyperactivity disorder (ADHD). The predominantly dopaminergic mechanism of the psychostimulant actions has become more clearly defined. Neuroimaging and genetic studies are revealing the underlying neuropa...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2.1.121
更新日期:2005-01-01 00:00:00
abstract:INTRODUCTION:Nanocomposite microparticles are intelligent carriers utilised for pulmonary drug delivery. These carriers are composed of drug-encapsulated nanoparticles dispersed in microstructures of polysaccharides. Upon administration, the inhaled microparticles can penetrate and be deposited deeply in the lung due t...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2016.1102224
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:The lung comprises an interesting route of administration not only for topical drugs but also for systemically acting drugs. Over the last years, several models have been developed in order to study the efficacy and safety of pulmonary drug delivery. OBJECTIVE:This review describes relevant drug delivery mo...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240903241788
更新日期:2009-11-01 00:00:00
abstract:INTRODUCTION:Skin disorders will continue to cause complications in patients. At present, there is an expansion of research into dermatologic treatment due to a critical need for new treatment options to treat skin diseases. AREAS COVERED:The skin itself provides a natural barrier against particle penetration for topi...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2012.686490
更新日期:2012-07-01 00:00:00
abstract::The use of gated mesoporous silica solids as suitable systems for controlled-release protocols is reviewed. These materials are based on mesoporous silica supports that can be prepared with tailor-made pores of around 2 - 10 nm and that show a very large specific surface area (up to 1200 m(2)/g), thus having a large l...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240902895980
更新日期:2009-06-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Spontaneously constructed from block copolymers in aqueous media, the polymer micelle has been extensively studied as a potential carrier of poorly water-soluble drugs, but cellular uptake pathways and stability of micelles in blood have not yet been clearly understood. An in-depth insight into ...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425240903380446
更新日期:2010-01-01 00:00:00
abstract:INTRODUCTION:Peptide and protein microarray and microneedle array technology provides direct information on protein function and potential drug targets in drug discovery and delivery. Because of this unique ability, these arrays are well suited for protein profiling, drug target identification/validation and studies of...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2013.797405
更新日期:2013-08-01 00:00:00
abstract:INTRODUCTION:Interest in mesoporous silica nanoparticles for drug delivery has resulted in a good understanding of the impact of size and surface chemistry of these nanoparticles on their performance as drug carriers. Shape has emerged as an additional factor that can have a significant effect on delivery efficacy. Rod...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2018.1517748
更新日期:2018-09-01 00:00:00
abstract:INTRODUCTION:Nanoparticles are anticipated to overcome persistent challenges in efficient drug delivery, but the limitations associated with conventional methods of preparation are resulting in slow translation from research to clinical applications. Due to their enormous potential, microfluidic technologies have emerg...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1080/17425247.2018.1446936
更新日期:2018-05-01 00:00:00
abstract:INTRODUCTION:Overexpression of VEGF has been identified to be associated with many pathologic processes such as tumors and retinopathy. Inhibiting uncontrolled growth of VEGF is a promising strategy to treat these diseases. Currently small molecule inhibitors and monoclonal antibodies are the primary treatment. However...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章,评审
doi:10.1517/17425247.2014.926886
更新日期:2014-09-01 00:00:00
abstract:OBJECTIVES:Methotrexate (MTX) is a chemotherapeutic and anti-inflammatory drug that may cause systemic adverse effects. This study investigated kinetics and biodistribution of MTX delivered topically by ablative fractional laser (AFXL). METHODS:In vitro passive diffusion of 10 mg/ml MTX (1 w/v%) was measured from 0.25...
journal_title:Expert opinion on drug delivery
pub_type: 杂志文章
doi:10.1517/17425247.2015.1031216
更新日期:2015-07-01 00:00:00