1993
DOI: 10.1016/s0272-6386(12)80928-0
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Identification of the Component Part in an Epoetin Alfa Preparation That Causes Pain After Subcutaneous Injection

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Cited by 46 publications
(20 citation statements)
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“…43,53,54,58,80,81,86,111,114,117,118,123 If the drug itself is found to be responsible for the pain on injection or tissue damage, the formulator could use a prodrug or salt form; 70,102,120 formulate the drug as a suspension or emulsion rather than as a solution; 43,56,[59][60][61][62]75,85,125 encapsulate the drug in some type of biocompatible/biodegradable carrier such as liposomes, 133 microspheres, 134 or mixed micelles; 63 or develop other novel drug complexes. Formulation changes can also involve modifications in the type of buffer, cosolvents, or other excipients used in the product 70,102,106,125 or altering the final pH of the product. [68][69][70]102 If necessary, the drug product labeling may include a recommendation that a specific vehicle or local anesthetic or other protective agent be administered concurrently with the drug.…”
Section: Methods To Reduce or Eliminate Pain On Injectionmentioning
confidence: 99%
See 1 more Smart Citation
“…43,53,54,58,80,81,86,111,114,117,118,123 If the drug itself is found to be responsible for the pain on injection or tissue damage, the formulator could use a prodrug or salt form; 70,102,120 formulate the drug as a suspension or emulsion rather than as a solution; 43,56,[59][60][61][62]75,85,125 encapsulate the drug in some type of biocompatible/biodegradable carrier such as liposomes, 133 microspheres, 134 or mixed micelles; 63 or develop other novel drug complexes. Formulation changes can also involve modifications in the type of buffer, cosolvents, or other excipients used in the product 70,102,106,125 or altering the final pH of the product. [68][69][70]102 If necessary, the drug product labeling may include a recommendation that a specific vehicle or local anesthetic or other protective agent be administered concurrently with the drug.…”
Section: Methods To Reduce or Eliminate Pain On Injectionmentioning
confidence: 99%
“…Buffers, cosolvents, antimicrobial preservatives, and chelating agents may, in some cases, be associated with injection site pain. 106,130,131 Final formulation factors such as pH, osmolarity, tonicity, solution temperature, drug concentration, and injection volume may be associated with pain upon injection. For peptides, it has been suggested that aggregation of proteins and particulates in general may contribute to pain.…”
Section: Drug and Formulation Factors Associated With Pain On Injectionmentioning
confidence: 99%
“…Pre-treatment with ice or a local anaesthetic cream (EMLA cream, Astra, Ontario, Canada) was not helpful. Not all preparations of rhEPO are painful, and recent studies [5] suggest that the pain is due to the citrate base used in Epoeitin Alpha Products -Epogen (Amgen, Calif., USA), Procrit (Ortho Pharm, N.J., USA), Eprex (Ortho Biotec, Ontario, Canada) or Eprex (Cilag, Switzerland). Less painful preparations such as Epogin (Chugai, Japan) and Recormon (Boehringer Mannheim, Germany) are used in Asia and Europe.…”
Section: Discussionmentioning
confidence: 99%
“…Parenteral formulations using these buffers and other excipients have the potential to cause damage and/or pain following injection. Citrate buffer has been reported to cause significantly more pain than 0.9% NaCl injection after subcutaneous administration in patients (4). Furthermore, the degree of pain was related to the injected concentration of citrate buffer.…”
Section: Introductionmentioning
confidence: 94%