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Ceutics Final P1-Spring > AERSOLS > Flashcards

AERSOLS Flashcards

1
Q

AEROSOL DOSAGE FORMS

A

Pressurized dosage forms that, upon actuation, emit a fine dispersion of liquid or solid materials containing one or more active ingredients in a gaseous medium

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2
Q

Inhalants

vicks / ammonia

amyl nitrate

A

Drug has a

  • *HIGH VAPORPRESSURE**
  • do not need propellant*

does not need anything for the
drug to be aerosoled

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3
Q

What Dosage Form?

Pressurized container

Solutions + Suspensions
CONTAINS PROPELLANT
admin by actuation

ex. Asthma drugs

A

AERSOL DOSAGE FORMS

includes
MDI’s

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4
Q

What Dosage Form?

Solid formulation in capsule / cartridge

not pressurized / no propellant

adminstered by ACTUATION

asthma drugs

A

DRY POWDER INHALER

DPI

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5
Q

What Dosage Form?

Drug solution administede with NEBULIZER

VENTURI Principle

Air pressure & droplet size important

A

INHALATION SOLUTION

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6
Q

Ideal respiratory delivery system

MDI & DPI

A

Formulation
stable formultion + package meeting design requirements

  • *Bioavailability**
  • *~1 micron partical size**

Compliance
ease of use & clinical advantages
counters / memory

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7
Q
  • *Aerosol**
  • *Properties**
A
  • *Particle Size**
  • *micronization –> ~1 micron size**

Physical Properties
density / spgr

  • *Vapor Pressure**
  • *escaping tendency // volatile CCl3F**

Chemical + Physical Stability
chemical reactivity / no rxn with package

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8
Q

Sealed canister containing formulation and propellant. Used in conjunction with an actuation device.

A

AEROSOLS

MDI / pMDI

could be continious or MDI

RAPID onset of action / EXACT dose

convenient / lower dose

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9
Q

Aerosol
Packaging / Components

A

RX products approved by FDA

CONTAINER
glass / pvc coated glass / metal / resin

VALVE Assembly
meter chamber for MDI
dip tube = al / resin / nlon

MDI Mouthpiece –> Actuator

MDI Spacer

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10
Q

Two-Phase System

A

Liquid propellant and vapor propellant

HIGH PROPELLANT CONTENT

Appropriate propellant combination

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11
Q

Three Phase System

A

WITH BALOON == WITH DRUG IN IT
drug that is SOLUBLE IN WATER

Aqueous, liquid propellant, and vapor propellant

Variable drug and propellant content

Appropriate propellant combination

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12
Q

Compressed Gas System

A

GAS PROPELLANT
N2 / CO2 / NO

no liquid component

HIGH DRUG Cntent

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13
Q

Propellants

A

Non-polar Liquid or Gas

CFC =
no longer used = deplete ozone

Non-CFC

CCl3F Trichlorofluoromethane (P-11) = propellant

CCl2F2 Dichlorodifluoromethane (P-12)

C2Cl2F4 Dichlorotetrafluoroethane (P-114)

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14
Q

Non-CFC Propellant

NAMING

CCl2F2

A

CCl2F2 = P-12

C = 1 - 1 // H = 0 +1 // F = 2
0 // 1 // 2

1st digit on right is number of F

2nd digit is 1 plus number of H

3rd digit is 1 minus number of C

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15
Q

Aerosol Formulation
when to use

SOLUTION or SUSPENSION

A

If the API is SOLUBLE in the PROPELLANT
V
USE SOLUTION
may add co-solvent –> aid solubility
alcohol /glycerol / propylene glycol

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16
Q

Specifications of Aerosols

PRODUCT REQUIREMENTS

A

Drug Content Assay

Dose UNIFORMITY // Particle size DISTRIUTION

Effect of STORAGE –> particle size

Plume Geometry

Profiling of actuations near canister exhaustion

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17
Q

Precautions of Active Ingredients

Nitroglycerin

A

Nitroglycerin is NOT FOR PULMONARY DELIVERY

18
Q

Precautions of Active Ingredients

Anesthetics

A

ANESTHETICS ON BROKEN SKIN

19
Q

Respiratory Drug Administration

A

SYNCHRONIZED
INSIPRATION + ACTUATION

Long -deep breath –> HOLD –> EXHALE

20
Q

Non-pressurized device that, upon activation, delivers a fine particle size material transported by patient inhalation.

A

DRY POWDERED INHALER

Flovent (fluticasone) Diskus

Serevent (salmeterol) Diskus

Pulmicort (budesonide) Turbuhaler

21
Q

Advantages of DPI

A

Rapid Onset

AVOID injection / First pass metaolism

PROTEIN absorption

22
Q

DPI Formulation

A

Micron-Sized Drug in variety of delivery forms:

Crystal Form

Excipient binding / blending

Surfase passivation

Drug-excipient complexes

23
Q

DPI Administration

  1. More than 25% of patients have difficulty with unit preparation
  2. More than 75% of patients have trouble with inhale, hold breath, exhale through mouth, etc. procedure.
A

VERY DIFFICULT FOR PATIENTS TO ADMIN

Initiate Dose / Activate Particles

SYNCHRONIZED INHALATION

Dose is Counted

rinse mouth

24
Q

Inhalation Solutions

A

Commercial products are sterile solutions in glass vials or plastic blow-fill-seal containers.

Products added to nebulizer apparatus.

Nebulizer enables administration of appropriate size droplets by means of the Bernoulli principle and venturi effect.

25
Q

Advantages of Aerosol Products
MDI / pMDI

A

Rapid Onset

EXACT DOSE

Convenience

26
Q

What dosage form uses a

METERING CHAMBER?

A

MDI ONLY

also needs a mouthpiece –> actuatior

SPACER

27
Q

Two Basic Propellant Systems

A
  • *LIQUEFIED GAS**
  • *in EQ w/ vapor pressure**
  • *propellant vapor pressure** basis for aerosol use
  • *COMPRESSED GAS**
  • DECLINES WITH PRESSURE USE*
28
Q

Valves

Continuous Vs Metered Dose

A

MDI = EXACT & REPEATABLE DOSE

Dip Tube structure –> product method of use

29
Q

Pressurized Ideal respiratory delivery system

(MDI, DPI, and inhalation solutions/devices)

A
  • *Formulation:**
  • *Stable formulation**
  • *including package** meeting design requirements
  • *Bioavailability:**
  • *Respirable particle delivery (1 micron particle size)**
  • *Compliance:**
  • *Ease of use and clinical advantages**
30
Q

Metered dose inhaler (MDI)

A

Actuator, mouthpiece, metering chamber, and dip tube, and mouthiece

Two-phase system:
Liquid propellant and vapor propellant. High propellant content

  • *Three-phase system:**
  • *Aqueous**, liquid propellant, and vapor propellant. Barrier (Bag-in-can, can-in-can)

Appropriate propellant combination

31
Q
  • *Dry powder Inhalers (DPI) –**
  • Non-pressurized device* that, upon activation,

delivers a fine particle size material transported by patient inhalation.

A

Solids formulation in capsule or cartridge

1 micron particle size with carrier system

Not pressurized – no propellant

Administered by actuation

32
Q

AEROSOL PHARMACIST COUNSELING

A

MDI and DPI relatively difficult for patient use. -

  • *anesthetics on broken skin,
  • Nitroglycerin not for pulmonary delivery***

Respiratory drugs – Synchronize inspiration with actuation

Long deep breath – hold – exhale. Repeat after a few seconds

Hold container in correct position – Upright or inverted

Shake container to mobilize particles

Firm pressure on actuator

Prime delivery device –first use (or after storage)

33
Q

Ostwald Ripening

A

Particle Size INCREASE

particles crystallize or deposit into larger sizes

ISSUE WITH TEMPERATURE for AEROSOLS
STORAGE

34
Q

Describe the propellant system that would be used for a MDI. Explain in one sentence why is this an appropriate system

A

Liquified gas.

Vapor pressure remains constant throughout product use.

Key point is constant vapor pressure or provides uniform dose throughout entire container.

35
Q

Describe two different applications of vapor pressure in inhalation dosage forms

A

MDI =
Vapor pressure is the propellant

Inhalants
DRUG ITESELF has vapor pressure
VICKS, you can just inhale it

36
Q
  1. Three reasons why patents must store aerosol dosage forms at the specific storage temperature
A

Too cold could affect vapor pressure propellant

Too hot
could cause explosion – too much pressure

Drug stability –
too hot could accelerate drug degradation reactions

Particle size increase
due to temperature cycling or Ostwald ripening.

37
Q
  1. Why use a cosolvent in an MDI formulation? Provide an example cosolvent molecule
A

A cosolvent enables an insoluble API to dissolve thereby providing a solution dosage form instead of a suspension dosage form.

Example cosolvents are
ethanol, propylene glycol, or other glycol
(accept other semi-polar solvents).

38
Q

Why calculate the vapor pressure of the propellant mixture in an aerosol dosage form?

A

The vapor pressure must be appropriate for the intended use.

Surface sprays, room sprays, sprays used for long distance spraying, foams, MDI, etc.

all have different vapor pressure requirements.

Also accept that the vapor pressure must not be too strong or powerful for human administration to the throat and lungs.

39
Q

What is the effect of the dissolved formulation ingredients

on the vapor pressure of a pharmaceutical aerosol product? Why?

A

Vapor pressure lowering.

Vapor pressure is a colligative property which is affected by molecules in solution.

40
Q

The propellant mechanism in a compressed gas aerosol and in an MDI aerosol are identical.

A

False.

The MDI uses an equilibrium between liquid and vapor propellant.

The compressed gas uses only gas under pressure

41
Q

Using micronized drug in a nasal spray formulation will enable the API to reach the alveoli in the lung.

A

False.
The micronized drug gets to the lung in an MDI, but not in a nasal spray.

Ceutics Final P1-Spring (6 decks)

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