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Expert Opinion on Drug Delivery Sep 2016Polyethylene glycol (PEG) is a polymer of choice in drug delivery systems. This USFDA-approved polymer is popular due to its tunable properties and well-established... (Review)
Review
INTRODUCTION
Polyethylene glycol (PEG) is a polymer of choice in drug delivery systems. This USFDA-approved polymer is popular due to its tunable properties and well-established safety profile: prime requisites considered during the selection of any excipient in formulation development.
AREAS COVERED
The unique properties and applications of PEG have been discussed at length in the existing literature. However, a proper guidance on selection of PEG grade to cater to one's purpose is lacking. This article provides preliminary guidelines to formulators on selection of appropriate PEG grade, typically based on its physico-chemical properties and role-based functional application in pharmaceuticals. It should be noted that the aim article is not to deep dive in each application area.
EXPERT OPINION
Guidance on PEG application and grade of choice is lacking in the available literature. The authors have discussed and provided guidance to formulators on the appropriate PEG grade selection for particular application based on the available in vitro and in vivo literature data. In this review a State-of-the-art use of PEG in therapeutic applications, its clinical status and commercial use is also summarized. Nevertheless, toxicities related to different PEG grades and related impurities are discussed in this review.
Topics: Chemistry, Pharmaceutical; Drug Delivery Systems; Polyethylene Glycols; Polymers
PubMed: 27116988
DOI: 10.1080/17425247.2016.1182485 -
The Journal of Allergy and Clinical... 2019
Topics: Anaphylaxis; Humans; Hypersensitivity, Immediate; Immunoglobulin E; Polyethylene Glycols; Polysorbates
PubMed: 31279466
DOI: 10.1016/j.jaip.2019.05.001 -
Journal of Pediatric Gastroenterology... Oct 2017According to international guidelines, polyethylene glycol (PEG) is the laxative of first choice in the treatment of functional constipation in children, both for... (Review)
Review
According to international guidelines, polyethylene glycol (PEG) is the laxative of first choice in the treatment of functional constipation in children, both for disimpaction and for maintenance treatment. PEG acts as an osmotic laxative and its efficacy is dose dependent. PEG is highly effective, has a good safety profile, and is well tolerated by children. Only minor adverse events have been reported. Overall the use of PEG in children has been reported to be safe, although in patients predisposed to water and electrolyte imbalances monitoring of serum electrolytes should be considered.
Topics: Child; Constipation; Contraindications, Drug; Drug Compounding; Drug Dosage Calculations; Humans; Laxatives; Polyethylene Glycols; Treatment Outcome
PubMed: 28777126
DOI: 10.1097/MPG.0000000000001704 -
Journal of Pediatric Gastroenterology... Aug 2013Constipation is a common problem in children worldwide. It can also be a chronic problem persisting for many months to years. Successful treatment of constipation... (Review)
Review
Constipation is a common problem in children worldwide. It can also be a chronic problem persisting for many months to years. Successful treatment of constipation requires long-term use of laxatives. Commonly used laxatives in children include milk of magnesia, lactulose, mineral oil, and polyethylene glycol. Compared with other laxatives, polyethylene glycol (with and without electrolytes) is a relatively new laxative used during the last decade. Recent studies report excellent efficacy and safety of polyethylene glycol for the long-term treatment of constipation in children. Because of excellent patient acceptance, polyethylene glycol has become a preferred choice of laxative for many practitioners. This article reviews the recently published pediatric literature on biochemistry, efficacy, safety, patient acceptance, and pharmacoeconomics of polyethylene glycol.
Topics: Child; Constipation; Humans; Laxatives; Patient Satisfaction; Polyethylene Glycols
PubMed: 23591910
DOI: 10.1097/MPG.0b013e318296404a -
Pediatrics International : Official... 2023
Topics: Humans; Diazepam; Polyethylene Glycols; Suppositories; Hypersensitivity; Anaphylaxis
PubMed: 36308464
DOI: 10.1111/ped.15402 -
Canadian Family Physician Medecin de... May 2009ABSTRACT QUESTION: I have come across many pediatric patients with functional constipation. Is polyethylene glycol 3350 without electrolytes a safe and effective... (Review)
Review
UNLABELLED
ABSTRACT QUESTION: I have come across many pediatric patients with functional constipation. Is polyethylene glycol 3350 without electrolytes a safe and effective long-term treatment option for these patients?
ANSWER
Functional constipation is a common and often difficult problem for parents and families to deal with. Polyethylene glycol 3350 is a safe and effective long-term laxative in pediatric populations, but there are limited studies for its use in children younger than 2 years of age.
Topics: Child; Constipation; Contraindications; Dose-Response Relationship, Drug; Electrolytes; Humans; Polyethylene Glycols; Treatment Outcome
PubMed: 19439699
DOI: No ID Found -
Pharmaceutical Research Jan 2005Polymeric gene delivery systems have been developed as an alternative for viral gene delivery systems to overcome the problems in the use of viral gene carriers.... (Review)
Review
Polymeric gene delivery systems have been developed as an alternative for viral gene delivery systems to overcome the problems in the use of viral gene carriers. Polymeric carriers have many advantages as gene carriers such as low cytotoxicity, low immunogenicity, moderate transfection efficiency, no size-limit, low cost, and reproducibility. In the efforts to develop safe and efficient polymeric gene carriers, polyethylene glycol (PEG) has widely been used because of its excellent characteristics. PEG-conjugated copolymers have advantages for gene delivery: (1) The PEG-conjugated copolymers show low cytotoxicity to cells in vitro and in vivo, (2) PEG increases water-solubility of the polymer/DNA complex, (3) PEG reduces the interaction of the polymer/DNA complex with serum proteins and increases circulation time of the complex, 4) PEG can be used as a spacer between a targeting ligand and a cationic polymer. A targeting ligand at the end of a PEG chain is not disturbed by the interaction of a cationic polymer with plasmid DNA, and the PEG spacer increases the accessibility of the ligand to its receptor. In this review, PEG copolymers as gene carriers are introduced, and their characteristics are discussed.
Topics: Animals; DNA; Drug Delivery Systems; Humans; Plasmids; Polyethylene Glycols; Polymers
PubMed: 15771224
DOI: 10.1007/s11095-004-9003-5 -
Drugs 2008Methoxy polyethylene glycol-epoetin beta (Mircera) is a continuous erythropoietin receptor activator, with a long half-life (approximately 130 hours). In patients with... (Review)
Review
Methoxy polyethylene glycol-epoetin beta (Mircera) is a continuous erythropoietin receptor activator, with a long half-life (approximately 130 hours). In patients with anaemia associated with chronic kidney disease (CKD), both on and not on dialysis, who had not previously received an erythropoiesis-stimulating agent (ESA), methoxy polyethylene glycol-epoetin beta administered intravenously or subcutaneously once every 2 weeks resulted in a smooth and steady rise in haemoglobin levels. The response rates were high (up to 97.5%) in these patients at the end of the correction period; response rates with the comparator ESAs (epoetin alfa or beta, or darbepoetin alfa) were up to 96.3%. Moreover, patients with CKD on dialysis who had previously been treated with an ESA maintained stable haemoglobin levels (within +/-1 g/dL of baseline and within a range of 10-13.5 g/dL) when directly converted to methoxy polyethylene glycol-epoetin beta administered intravenously or subcutaneously once every 2 or 4 weeks. Methoxy polyethylene glycol-epoetin beta is generally well tolerated, with most adverse events being of mild to moderate severity, consistent with the co-morbidities known to occur in this patient group and those reported with other ESAs. In conclusion, in patients with anaemia associated with CKD, subcutaneous or intravenous methoxy polyethylene glycol-epoetin beta achieved a high haemoglobin response rate (ESA-naive patients) when administered once every 2 weeks and maintained stable haemoglobin levels (patients previously treated with ESAs) when administered once monthly.
Topics: Anemia; Chronic Disease; Clinical Trials, Phase III as Topic; Drug Costs; Economics, Pharmaceutical; Erythropoietin; Hematinics; Humans; Kidney Diseases; Polyethylene Glycols; Recombinant Proteins
PubMed: 18484803
DOI: 10.2165/00003495-200868080-00009 -
Current Medical Research and Opinion Jul 2011To explore the clinical dimensions of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 (MiraLAX * ) in... (Review)
Review
OBJECTIVE
To explore the clinical dimensions of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 (MiraLAX * ) in particular. * MiraLAX is a registered trade name of Schering-Plough HealthCare Products, Inc., Memphis, TN, USA, a subsidiary of Merck & Co., Inc.
RESEARCH DESIGN AND METHODS
Published reports of clinical trials involving polyethylene glycol 3350, together with published articles examining the epidemiology, demographics, etiology, evaluation, and management of chronic constipation, were identified in a literature search through November 2009 using PubMed. Congress proceedings and guideline databases of leading national and international gastroenterology associations were also explored for relevant recommendations and evaluations.
MAIN OUTCOME MEASURES
Constipation, often defined differently by patients and physicians, is typically associated with excessive straining, hard stools, infrequent bowel movements, and sensations of incomplete evacuation. Specific criteria are available to aid physicians in making a diagnosis of functional constipation. Initial patient management typically involves dietary and lifestyle changes, although this approach is supported by limited clinical evidence and is often a source of considerable patient frustration. A laxative is needed when these changes do not sufficiently relieve constipation. Multiple agents from several different laxative classes are available, differing in mechanism of action, safety and efficacy profile, and clinical evidence supporting their use.
RESULTS
Twenty-one studies involving a total of 1949 patients were included in the overall review of polyethylene glycol 3350. Fifteen studies used randomized designs, eight were comparative trials, seven were conducted in pediatric populations, and three had elderly components.
LIMITATIONS
Limitations of this review included lack of comparability among the various patient populations described; focus on a single agent; potential publication bias; non-systematic review.
CONCLUSIONS
Polyethylene glycol 3350, an osmotic laxative available over the counter, has been shown to be safe and effective in treating chronic constipation in children and adults, including the elderly, across multiple clinical trials, with a safety profile comparable to that of placebo. Polyethylene glycol 3350 received a grade A recommendation for improving stool frequency and consistency from the American College of Gastroenterology Task Force on Chronic Constipation.
Topics: Adult; Algorithms; Child; Constipation; Evidence-Based Practice; Humans; Laxatives; Nonprescription Drugs; Polyethylene Glycols; Randomized Controlled Trials as Topic
PubMed: 21604961
DOI: 10.1185/03007995.2011.580339 -
Journal of Drug Targeting 1996Of all the polymers applied to molecule altering structural chemistry, polyethylene glycol (PEG) modification has numerous benefits and relatively few drawbacks. PEG is... (Review)
Review
Of all the polymers applied to molecule altering structural chemistry, polyethylene glycol (PEG) modification has numerous benefits and relatively few drawbacks. PEG is now increasingly being applied to the problems of tumour targeting, both in the context of the passive targeting of PEG-liposomes and in active targeting strategies using PEGylated anti-tumour antibodies. PEG can also serve as a useful linker molecule between targeting moieties and other agents, including cytotoxic or imaging agents and targeted liposomes. Despite these demonstrated benefits and the level of attention which PEGylation has received, relatively little consideration has been given to two key areas: first, the extent to which the coupling method has an impact on both the functionality of the PEG-adduct and the acquisition of beneficial properties; second, that the impact of PEGylation on biodistribution is complex, thus any attempt to optimise a PEG-peptide or PEG-liposome for a particular task must involve an examination of all the individual facets of the effects of PEGylation. Studies investigating the underlying principles of tumour targeting suggest that current views concerning the optimisation of PEGylated vehicles for tumour localisation need to be re-examined.
Topics: Antibody Formation; Binding Sites; Drug Delivery Systems; Granulocyte-Macrophage Colony-Stimulating Factor; Humans; Liposomes; Neoplasms; Peptides; Polyethylene Glycols; Proteins; Recombinant Proteins; Structure-Activity Relationship; Tissue Distribution
PubMed: 8866652
DOI: 10.3109/10611869608996824