Sterile products- formulation Flashcards
Types of sterile products
Parenteral products e.g. injections, infusions
Ophthalmic products e.g. eye drops, eye ointments, contact lens solutions
Sterile fluids e.g. water for irrigation, haemodialysis and peritoneal dialysis solutions
Medical devices e.g. artificial heart pumps. dressings
Parenteral preparations definition
Sterile preparations intended for administration by injection, infusion or implantation into the human or animal body
Why are excipients added to parenteral preparations?
To make isotonic with blood/cells
To adjust the pH
To increase the solubility of active drug
To prevent deterioration of the active ingredients
To provide adequate antimicrobial properties
These should not adversely affect the intended medicinal action or, at concentrations used, cause toxicity or undue local irritation
What containers are used for parenteral preparations?
Manufactured in containers made as far as possible from materials that are sufficiently transparent to permit the visual inspection of the contents, except for implants and in other justified and authorised cases
e.g. glass, plastic, coated glass
ampoules, vials, infusion bottles, infusion bags etc.
Types of parenteral drug systems
Aqueous solutions/ suspensions Oily injections/ suspensions Emulsions Colloidal solutions Mixed solvent systems Concentrated solutions Powders for injection Implants
What are the routes on parenteral drug delivery?
Intravenous Intramuscular Subcutaneous Intradermal Intra-arterial Intra-spinal Intra-thecal Intra-cardiac Intra-mammary
Characteristics of the intravenous route
Directly into a prominent vein- rapid response as directly into blood, in theory 100% bioavailability, titrate dose to response
Small volumes- up to 10mL may be given by bolus injection
10-50mL injections should be controlled by a syringe driver as slow push
50mL to 3L or greater should be delivered to a large vein using an infusion pump
What are the five potential problems of inserting a catheter?
Phlebitis Infection Bruising Extravasation Infiltration
Characteristics of the intramuscular route
Small volume injection into a relaxed muscle mass, 2mL into arm, 5mL into buttock
Rate off injection controlled by pain patient suffers
Drug bioavailability controlled by parenteral dosage formulation- suspension having delayed release rates
Must avoid blood vessel, excess volume may damage muscle tissue
Characteristics of the subcutaneous route
Injection of small doses usually (less than 1mL) into loose connective tissue below dermis layer of the skin
Large local response- without large uptake of drug in bloodstream e.g. local anaesthetics
Slower uptake than intramuscular route, but faster than oral route
Insulin pumps
Dosage instructions are entered into the pump’s small computer and the appropriate amount of insulin is then injected into the body in a calculated, controlled manner
What are the five regions of the spine?
Cervical Thoracic Lumbar Sacral Coccyx
The intra-spinal route
Aqueous injection of not more than 29mL into particular areas of the spinal cavity
The solutions should not contain antioxidants or preservatives
Should be single dose preparations with ampoule presented in a clear sterilised overwrap
Adjustment to isotonicity is critical, control of specific gravity of medicament may be important
National Patient Safety Agency (NPSA)- intrathecal injections
Doctor sentenced to 8 months jail for wrong drug into spinal cord
Intra-spinal delivery: future
Colour code delivery equipment and administration sets
Non-compatibility with IV equipment, administration sets and syringes
Factors to consider in the formulation of parenterals
Clinical/economic research Legal requirements Formulation issues Manufacturing issues Quality assurance/quality control
