Prednisolone Sodium Metazoate

Prednisolone sodium metazoate, also known as prednisolone metasulfobenzoate sodium or PRED-MSB, is indicated for use in the treatment of inflammatory bowel disease, ulcerative colitis, proctitis, and GI disorders. Prednisolone sodium metazoate is a poorly adsorbed analog of prednisolone, a synthetic glucocorticoid with similar properties to prednisolone as an anti-inflammatory agent with immuno-suppressant glucocorticoid properties. After cell surface receptor attachment and cell entry, prednisolone enters the nucleus where it binds to and activates specific nuclear receptors [glucocorticoid response elements (GRE)], resulting in an altered gene expression and inhibition of proinflammatory cytokine production. The anti-inflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins and lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Prednisolone Sodium Metazoate

CAS Registry Number:
630-67-1
Trade name:
Predfoam® and Predenema®
Cost:
$639 USD

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Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Prednisolone Sodium Metazoate, just click the ADD TO CART button.

HBEL

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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.

Affygility Solutions’s OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing
  • Pharmatek Laboratories