AP - Eye & Ear, Parenteral, Nasal & Pulmonary Drug Delivery Flashcards
Preformulation information?
- solubility
- pKa
- stability (in solution, formulation and API itself)
- log P
- toxicity profile
- analytical assay
Auricular or Otic or Aural drug delivery means drug delivery to the…
ear.
Since drug is only applied to outer part of ear, drug is not absorbed ________.
systemically. Therefore, topical drug delivery rules apply.
In order to have a stable suspension, and want some interaction between a drug with average-low water solubility, and the solvent, you can add a ________.
Wetting agent - surfactant
What can modify viscosity?
Gelling agents
Name a few flocculating agents.
- Electrolytes (sodium salts - acetate, phosphate)
- ionic surfactants
- polymeric agents
How do you prepare a suspension
Dissolve buffer in solvent. Add buffering agent, preservative and gelling agent (viscosity modifier) and mix to get uniform clear solution. Add the API last and mix thoroughly.
During suspension preparation, why is the API added last?
To ensure only API is suspended and not the other excipients such as gelling agent.
What are the stability tests for suspensions? (Three things)
- Particle size analysis (make sure it hasn’t increased in size as this can cause local irritation)
- Viscosity
- Degree of flocculation
Ocular drug delivery are used for…
the eye.
Eye formulations are delivered ______
locally.
Solutions can be dispensed as _____ and _____
drops and irrigation solutions
Suspensions can be dispensed as ______
drops.
Particle size for eyes must be
< 100um
Eye drops or anything administered to eyes MUST be
sterile.
Buffering capacity for eye should have a pH of _____
7.4