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Parenteral Dosage Forms - Sterile Pharmaceutical Dosage Forms

Parenteral Dosage Forms - Sterile Pharmaceutical Dosage Forms

Parenteral Dosage Forms - The term parenteral is derived from two Greek words ‘‘para’’ and ‘‘enteron’’ meaning ‘to avoid the intestine’.
Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body.

Characteristics of parenteral dosage forms

  • All parenteral products must be sterile.
  • All parenteral products must be free from pyrogenic (endotoxin) contamination.
  • Injectable solutions must be free from any visible particulate matter.

Advantages of parenterally administered drugs

  • Parenteral route is suitable for uncooperative, uncontrollable, nauseous or unconscious patients.
  • This route gives a quick response to the emergency situation.
  • This route provides rapid onset of action because drug directly goes into the circulation without a need for release or absorption step from a formulation.
  • Avoid the problems of GI irritation, drug inactivation and variable absorption because of avoidance of gastrointestinal tract.

Disadvantages of parenterally administered drugs

  • Parenteral route is potential for infection at the site of injection.
  • Sterilization is the necessary step in the production of parenteral dosage forms.
  • Parenteral product requires strict control of sterility and non-pyrogenicity than other formulation.
  • Invasive assistance required.
  • It causes pain on injection.
  • Only trained and skilled personnel are required to inject the drugs.
  • More expensive and costly to produce.

PARENTERAL ROUTES OF ADMINISTRATION

Drugs may be injected into almost any organ or area of the body, including the joints, joint fluid area, spinal column, spinal fluid, arteries, and in an emergency, even the heart. However, most injections go into a vein, into a muscle, into
the skin, or under the skin.

Evaluation of Parenteral Preparations

Various tests and assays should be performed on the finished preparation to ensure that it meets the required
specifications.
1. Sterility test
2. Pyrogen test
3. Clarity test
4. Leaker test

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