Injections and sterile formulations
To remember:
Injections: can have rehydration!
SC: 2.7-9
Intralipid: o/w emulsion, IV, calories and fatty acids NaOH for pH
Optimise solubility: salt form, simple formulation, balance stab and sol
Infusion: water continuous phase
Aseptic: aseptic fill-finish process
Ointment: reducing drug drainage by tear flow, increasing corneal residence time
ILOs
Discuss novel approaches of formulation and drug targeting, such as implants, responsive
pump systems, repurposing of drugs, novel formulations changing PK, PEGylation of colloids,
nano-formulation (ceutics team to review wording)
What components make an injection sterile?
- Free from micro-organisms
- Minimum levels of particles, pyrogenic substances and contaminants
- Generally isotonic with body fluids
- Has selected components to eliminate contaminants
o Contaminants: microbial, physical and chemical
What are pyrogenic substances?
- Released substances from microorganisms after they die
How do we determine the size of a needle to inject?
- Smaller needle possible-less painful
- That a drug can pass through
- e.g, colloids may need a larger needle due to larger drug size
What is total parenteral nutrition?
- All necessary nutrients
- Delivered into the blood via an oral feeding tube
o Enteral route
- Given by an infusion
- And drugs can be delivered via this method if needed
When do we use total parenteral nutrition?
- Due to GI disorders
- severe malnutrition
- or digestive system needs healing
How are sterile products prepared?
- Aseptic conditions
- Or terminal sterilisation
Examples of sterile parenteral products
- Injections
- Eye preparations
- Dressings
- Sutures
Why must eye products be sterile?
- Tissues are very sensitive to contamination
, What is an ophthalmic product?
- Sterile product
- For the eye
When do we use intravitreally route? What is it?
- Injection into the eye
- Autoimmune diseases
- Age related macular degeneration
o Vision disorder in older adults
What is an irrigating product?
- products used during washing, irrigation, rinsing
- e.g. used for washing of your eyes if a spillage has been made in the lab
What are parenteral products?
- preparations intended for injection through the skin or other external boundary
tissue
- preparations that don’t enter the GI tract
- although frequently the term is used to mean an injection
- implants and drug eluting stents are also examples of parenteral products
5 types of injection and what are they
Injection
- liquid preparation
- drug substances or solutions
…for injection
- dry solids
- upon addition of a suitable vehicle conform into a solution
… injectable emulsion
- liquid preparations
- solid dispersed or dissolved in an emulsion medium
… injectable suspension
- liquid preparation
- solid suspended in liquid medium
… for injectable suspension
- dry solids
- added into a suitable yield
- forms a solution
Excipients in injections
- buffers
- preservatives
Which types of injection cannot be administered by IV? Why?
- Suspension: particles block blood capillaries
- w/o emulsion: oil phase can cause a fat embolism blocking vesicles
What route do you administer w/o emulsion and suspension
- SC
- IM
Advantages of injections
- Rapid onset of action-IV
- Delayed or prolonged action-IM
- Avoid intestinal deactivation of the drug
To remember:
Injections: can have rehydration!
SC: 2.7-9
Intralipid: o/w emulsion, IV, calories and fatty acids NaOH for pH
Optimise solubility: salt form, simple formulation, balance stab and sol
Infusion: water continuous phase
Aseptic: aseptic fill-finish process
Ointment: reducing drug drainage by tear flow, increasing corneal residence time
ILOs
Discuss novel approaches of formulation and drug targeting, such as implants, responsive
pump systems, repurposing of drugs, novel formulations changing PK, PEGylation of colloids,
nano-formulation (ceutics team to review wording)
What components make an injection sterile?
- Free from micro-organisms
- Minimum levels of particles, pyrogenic substances and contaminants
- Generally isotonic with body fluids
- Has selected components to eliminate contaminants
o Contaminants: microbial, physical and chemical
What are pyrogenic substances?
- Released substances from microorganisms after they die
How do we determine the size of a needle to inject?
- Smaller needle possible-less painful
- That a drug can pass through
- e.g, colloids may need a larger needle due to larger drug size
What is total parenteral nutrition?
- All necessary nutrients
- Delivered into the blood via an oral feeding tube
o Enteral route
- Given by an infusion
- And drugs can be delivered via this method if needed
When do we use total parenteral nutrition?
- Due to GI disorders
- severe malnutrition
- or digestive system needs healing
How are sterile products prepared?
- Aseptic conditions
- Or terminal sterilisation
Examples of sterile parenteral products
- Injections
- Eye preparations
- Dressings
- Sutures
Why must eye products be sterile?
- Tissues are very sensitive to contamination
, What is an ophthalmic product?
- Sterile product
- For the eye
When do we use intravitreally route? What is it?
- Injection into the eye
- Autoimmune diseases
- Age related macular degeneration
o Vision disorder in older adults
What is an irrigating product?
- products used during washing, irrigation, rinsing
- e.g. used for washing of your eyes if a spillage has been made in the lab
What are parenteral products?
- preparations intended for injection through the skin or other external boundary
tissue
- preparations that don’t enter the GI tract
- although frequently the term is used to mean an injection
- implants and drug eluting stents are also examples of parenteral products
5 types of injection and what are they
Injection
- liquid preparation
- drug substances or solutions
…for injection
- dry solids
- upon addition of a suitable vehicle conform into a solution
… injectable emulsion
- liquid preparations
- solid dispersed or dissolved in an emulsion medium
… injectable suspension
- liquid preparation
- solid suspended in liquid medium
… for injectable suspension
- dry solids
- added into a suitable yield
- forms a solution
Excipients in injections
- buffers
- preservatives
Which types of injection cannot be administered by IV? Why?
- Suspension: particles block blood capillaries
- w/o emulsion: oil phase can cause a fat embolism blocking vesicles
What route do you administer w/o emulsion and suspension
- SC
- IM
Advantages of injections
- Rapid onset of action-IV
- Delayed or prolonged action-IM
- Avoid intestinal deactivation of the drug
