10/9/2019
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`The Pharmaceutics and Compounding Laboratory
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`The Pharmaceutics and Compounding Laboratory
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`Content
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`Labs
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`Videos
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`Test
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`Sterile Compounding
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`Introduction
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`Routes
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`Injection Dependent Routes
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`Injection Independent Routes
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`Equipment
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`Devices and Supplies
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`Aseptic Techniques
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`Additional Considerations
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`Routes of Administration Requiring Sterile Formulations
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`Some routes of administration demand that products do not bring microbial
`contamination with them into the body. This is required because some routes of
`administration by-pass the body's natural defense mechanisms, or some tissues or
`organs are so sensitive and vital that such contamination could be serious.
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`All of these "sterility demanding" routes are parenteral routes.
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`NOTE: But not all parenteral routes are "sterility demanding" routes.
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`The term parenteral means next to or beside the enteral. Enteral
`refers to the alimentary tract, so parenteral means sites that are
`outside of or beside the alimentary tract. Since oral, buccal,
`sublingual, and rectal comprise the enteral routes of
`administration, any other route is considered a parenteral
`administration site. Topical administration is a parenteral route
`that does not require sterile formulations.
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`The parenteral routes of administration are used for various reasons.
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`If a drug is poorly absorbed when orally administered or is degraded by
`stomach acid or the gastrointestinal enzymes, then a parenteral route would
`be indicated.
`The parenteral routes are also preferred when a rapid and predictable drug
`response is desired as in a emergency situation.
`Parenteral routes of administration are also useful when a patient is
`uncooperative, unconscious, or unable to take drug via an enteral route.
`Parenteral routes are used when localized drug therapy is desired.
`They provide a predictable and nearly complete bioavailability.
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`But there are major disadvantages.
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`Most of these parenteral formulations are more expensive than enteral route
`formulations.
`Most these parenteral formulations must be sterile.
`Many formulations require that a skilled or trained person administer them.
`Once the drug is administered, it may be difficult to remove the dose is there if
`an adverse or toxic reaction.
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`https://pharmlabs.unc.edu/labs/parenterals/routes.htm
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`UCB Biopharma SPRL (IPR2019-00400)
`Exhibit 2016 Page 1
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