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Dubost, David C.; Kaufman, Michael J.; Zimmerman, Jeffrey A.; Bogusky, Michael J.; Coddington, A.; Pitzenberger, Steven M.

doi:10.1023/a:1016024923002

Cited by 41 publications

(1 citation statement)

References 5 publications

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“…The new identified degradation products of phenylephrine found in pharmaceutical preparations against the common cold containing phenylephrine and saccharose. solid state to give an aldehyde as an oxidation product [26]. The oxidative pathway does not require oxygen but does depend on the presence of impurities in the pharmaceutical excipient used in the formulation.…”

Section: Phenylephrine Reaction With Formaldehyde and 5-hmfmentioning

confidence: 99%

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Hotha¹,

Roychowdhury²,

Subramanian³

2016

AJAC

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The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms.

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Section: Phenylephrine Reaction With Formaldehyde and 5-hmfmentioning

confidence: 99%

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Hotha¹,

Roychowdhury²,

Subramanian³

2016

AJAC

View full text Add to dashboard Cite

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Stability Assessment and Formulation Characterization

Chow

Tong

Zheng

2010

Pharmaceutical Sciences Encyclopedia

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A drug needs to be formulated in a safe, consistent, and stable dosage form with proven clinical efficacy before it can be approved for specific therapeutic indications by drug regulatory authorities. Depending on the modes of chemical degradation or physical denaturation, a wide variety of formulation excipients or additives, including buffers, antioxidants, sugars, and polysaccharides, can be used to preserve the structural integrity and biological activity of such vulnerable macromolecules. This article focuses on the stability problems of biopharmaceuticals and their assessment as well as the formulation approaches that can be used to circumvent these problems.

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Progress in Design of Biodegradable Polymer‐Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein

Shunmugaperumal

2010

Pharmaceutical Sciences Encyclopedia

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Microspheres prepared from biodegradable polymers are widely recognized for controlled drug delivery following parenteral administration. Polyester polymers such as poly(lactic acid) (PLA), poly(glycolic acid) (PGA), and their copolymer poly(lactic acid‐co‐glycolic acid) (PLGA) are used routinely for the preparation of injectable microspheres due to their biocompatibility, controlled biodegradability, and no toxicity of degradation products. This article focuses on investigations made progressively on the design of injectable peptide/protein‐loaded PLGA microspheres

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Abstract: Reducing sugar impurities in mannitol are responsible for the oxidative degradation of the peptide via a mechanism that involves Schiff base intermediates. This mechanism may be a potential route of degradation of other arylmethyl amines in mannitol-based formulations.

Cited by 41 publications

References 5 publications

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Stability Assessment and Formulation Characterization

Progress in Design of Biodegradable Polymer‐Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein

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