AP - Eye & Ear, Parenteral, Nasal & Pulmonary Drug Delivery Flashcards Preview

CH344 > AP - Eye & Ear, Parenteral, Nasal & Pulmonary Drug Delivery > Flashcards

Flashcards in AP - Eye & Ear, Parenteral, Nasal & Pulmonary Drug Delivery Deck (42):
1

Preformulation information?

- solubility
- pKa
- stability (in solution, formulation and API itself)
- log P
- toxicity profile
- analytical assay

2

Auricular or Otic or Aural drug delivery means drug delivery to the...

ear.

3

Since drug is only applied to outer part of ear, drug is not absorbed ________.

systemically. Therefore, topical drug delivery rules apply.

4

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

5

What can modify viscosity?

Gelling agents

6

Name a few flocculating agents.

- Electrolytes (sodium salts - acetate, phosphate)
- ionic surfactants
- polymeric agents

7

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.

8

During suspension preparation, why is the API added last?

To ensure only API is suspended and not the other excipients such as gelling agent.

9

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

10

Ocular drug delivery are used for...

the eye.

11

Eye formulations are delivered ______

locally.

12

Solutions can be dispensed as _____ and _____

drops and irrigation solutions

13

Suspensions can be dispensed as ______

drops.

14

Particle size for eyes must be

< 100um

15

Eye drops or anything administered to eyes MUST be

sterile.

16

Buffering capacity for eye should have a pH of _____

7.4

17

Define parenteral drug delivery.

Administration of drug not through alimentary canal but rather by injection through an alternate route e.g. subcutaneous (under skin), IM (depot injections - oily solutions), IV (can be short acting/ long acting infusions), IA (infusions), IS (anti cancer, epidural), ID (vaccines), IC (adrenaline) e.t.c.

18

What are some reasons for using parenteral drug delivery?

1. If drug is not stable in GI tract and cannot go through any other route of administration e.g. insulin
2. GI enzymatic activity
3. Low absorption --> 1st pass metabolism
4. Variable absorption from patient to patient

19

Advantages of parenteral?

- Quick drug delivery
- Rapid onset of action
- Ideal alternative when oral therapy is not possible
- Accurate dosage
- Used for systemic and local effect
- Implants and depot for prolonged action
- Suitable for parenteral nutrition and for continuous medication

20

Disadvantages of parenteral?

- Patient compliance
- Administered by trained medical professionals
- Once administered, no way it can be altered --> nearly impossible to reverse the effects
- Stringent manufacturing and packing requirements leading to higher production costs

21

Types of parenteral formulations

- Solutions (can be dispensed individually as powders with a separate solvent)
- Suspensions (can be dispensed individually as powders with a separate vehicle)
- Liposomes
- Emulsions

22

What is the dose for small volume parenteral products?

0.1ml - 1.5ml
(single bolus injection suitable for i.m, s.c, i.v etc)

23

What is the dose for large volume parenteral products?

>100ml
(usually for parenteral nutrition)

24

Choice of small volume or large volume depends on...

if you want it to act immediately (SVP) or over a long period of time (LVP).

25

Disadvantage of SVP?

- Fixed conc (manufacturer regulated)
- If frozen --> thawing --> can lead to altered product stability.

26

What are the excipients for injections?

PASSBV
- Preservatives
- Antioxidants
- Solvents; aqueous - water for injection; aqueous miscible - propylene glycol, glycerol, PEG
- Solubilising agents e.g. surfactants
- Buffers; salts e.g. NaCl
- Viscosity modifiers e.g. methylcellulose

27

Water for injection is obtained by which process? ______ or _______ _______

Distillation or Reverse osmosis

28

Water for injection is free from _____, ______ and _______

particulates, pyrogens and bacteria.

29

Water for injection; quick production to utility to minimise _________

contamination.

30

Water miscible solvents are used as co-solvents to increase _______/ _______.

solubility/ stability.

31

Non aqueous are usually used for _______

intramuscular depot injections

32

Preservatives are used at much lower concentrations for parenteral injections than topical formulations. Why?

Because they are sterile manufactured or stabilised. Therefore, need to keep small amounts to maintain sterility.

33

What are buffer salts used for in parenteral drugs?

To stabilise the drug.

34

What is blood osmolality value?

280 - 303 milliosmoles.

35

Which is preferred hypertonic or hypotonic?

Hypertonic

36

Nacl, dextrose and mannitol are all?

Tonicity modifiers

37

What are some buffers used in parenteral products?

Ammonium
Acetate
Bicarbonate
Citrate (used for acidic)
Phosphate (used for ph 5-7)

38

If parenteral product is sterile, only need to add preservative if... ?

multi dose units are used

39

If a drug has poor water solubility what can you do?

- pH manipulation --> make it more acidic/ alkaline
- use co-solvents
- surfactants
- complexing agents
- emulsions
- NEED TO ANALYSE STABILITY OF FINAL PRODUCT BEFORE GOING AHEAD.

40

Particle size for suspension in injections is

< 5um

41

What are some adverse effects following parenteral administration

- Precipitation
- Haemolysis due to hypotonic formulations
- Pain (IM route due to pH or co-solvent conc)
- Phlebitis - pain, oedema

42

What is the QC or injections?

sterility test
pyrogen test
particulate matter
microscopic test