Pda journal of pharmaceutical science and technology pdf

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pda journal of pharmaceutical science and technology pdf

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The content and views expressed in this technical report are the result of a consensus achieved by the authoring. PDA Journal of Pharmaceutical. This revision of the original report was developed in response to enhancements in filtration.

Particulate Matter in Injectable Drug Products

Elemental impurities in drug products can arise from a number of different sources and via a number of different means, including the active pharmaceutical ingredient, excipients, the vehicle, and leaching of elemental entities that are present in the drug product's manufacturing or packaging systems. Thus, knowledge about the presence, level, and likelihood of leaching of elemental entities in manufacturing and packaging systems is relevant to understanding how these systems contribute to a drug product's total elemental impurity burden.

This review article contains the information compiled from the available body of literature and considers two questions: 1 What elemental entities are present in the relevant polymers and materials and at what levels are they present? Conclusions drawn from the compiled data are as follows: 1 Elemental entities are present in the materials used to construct packaging and manufacturing systems as these materials either contain these elemental entities as additives or are exposed to elemental entities during their production.

Thus, while sources of certain elemental impurities may be ubiquitous in the natural environment, they are not ubiquitous in materials used in pharmaceutical packaging and manufacturing systems and when they are present, they are not extensively leached under relevant conditions.

The information summarized here can be utilized to aid the elemental impurity risk assessment process by providing the identities of commonly reported elements and data to support probability estimates of those becoming elemental impurities in the drug product. Furthermore, recommendations are made related to establishing elements of potential product impact for individual materials.

Lay abstract: Extraneous impurities in drug products provide no therapeutic benefit and thus should be known and controlled. Elemental impurities can arise from a number of sources and by a number of means, including the leaching of elemental entities from drug product packaging and manufacturing systems. To understand the extent to which materials used in packaging systems contain elemental entities and the extent to which those entities leach into drug products to become elemental impurities, the Extractables and Leachables Safety Information Exchange ELSIE and International Pharmaceutical Aerosol Consortium on Regulation and Science IPAC-RS Consortia have jointly performed a literature review on this subject.

Using the compiled information, it was concluded that while packaging materials may contain elemental entities, unless those entities are intentional parts of the materials, the amounts of those elemental entities are generally low. Furthermore, generally only a very small fraction of the total available amount of the entity can be leached under conditions that are relevant to packaged drug products. Thus, risk assessment of sources of elemental impurities in drug products that may be related to materials used in pharmaceutical packaging and manufacturing systems can utilize the information and recommendations presented here.

Keywords: Elemental impurities; Extractables; Leachables; Packaging systems; Pharmaceutical manufacturing systems; Polymers. Abstract Elemental impurities in drug products can arise from a number of different sources and via a number of different means, including the active pharmaceutical ingredient, excipients, the vehicle, and leaching of elemental entities that are present in the drug product's manufacturing or packaging systems.

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Design and validation of isolator systems for the manufacturing and testing of health care products. Technical Report No. Parenteral Drug Association. Blend uniformity analysis: validation and in-process testing. PDA Parenteral Drug association. Technical report: bioburden recovery validation. Journal of Parenteral Science and Technology 44 6 : ,

Elemental impurities in drug products can arise from a number of different sources and via a number of different means, including the active pharmaceutical ingredient, excipients, the vehicle, and leaching of elemental entities that are present in the drug product's manufacturing or packaging systems. Thus, knowledge about the presence, level, and likelihood of leaching of elemental entities in manufacturing and packaging systems is relevant to understanding how these systems contribute to a drug product's total elemental impurity burden. This review article contains the information compiled from the available body of literature and considers two questions: 1 What elemental entities are present in the relevant polymers and materials and at what levels are they present? Conclusions drawn from the compiled data are as follows: 1 Elemental entities are present in the materials used to construct packaging and manufacturing systems as these materials either contain these elemental entities as additives or are exposed to elemental entities during their production. Thus, while sources of certain elemental impurities may be ubiquitous in the natural environment, they are not ubiquitous in materials used in pharmaceutical packaging and manufacturing systems and when they are present, they are not extensively leached under relevant conditions.

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Once production of your article has started, you can track the status of your article via Track Your Accepted Article. Journal of Pharmaceutical Sciences www. Access here additional scientific content published in the Journal of Pharmaceutical Sciences including: "freely available" Dedicated Issues to "Giants in the Pharmaceutical Sciences"; "freely available" Special Issue on Pharmaceutical Biotechnology;

PDA Journal of Pharmaceutical Science and Technology

PDA Journal of Pharmaceutical Science and ... - store.pda.org

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Clinicians have had concerns about particulate matter contamination of injectable drug products since the development of the earliest intravenous therapeutics. All parenteral products contain particulate matter, and particulate matter contamination still has the potential to cause harm to patients. View on PDA.

United States Universities and research institutions in United States. Pharmacology, Toxicology and Pharmaceutics Pharmaceutical Science. Parenteral Drug Association Inc.

How to decide whether a statistically significant trend is of practical relevance? In the context of stability data of pharmaceuticals, this publication provides a way forward to use different measures of method variability to compare to the observed changes over time. A panel of analytical experts assessed whether statistical significant Solubility of the drug is a significant aspect to be considered during manufacturing of pharmaceutical products. Poor aqueous solubility of drugs imparts depleted bioavailability. In this regard, several techniques are available for enhancing drug solubility or dissolution. However, only a few of them are scalable and industrially applicable.


PDA Journal of Pharmaceutical Science and Technology · David Hall Vice President, Sales Tel: +1 () Email: [email protected] · Alison Caballero Sr.


Journal of Pharmaceutical Sciences

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