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Ceutics Final > Random Shit u think is important for Pluta Lectures > Flashcards

Random Shit u think is important for Pluta Lectures Flashcards

1
Q

Dea Form 483

A

GMP (general manufacturing process) Law Penalty for improper manufacturing Comes before warning letter > decree/fine > DEBARRED

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2
Q

Pharmaceutical Compounding Process

A
  1. RX Receipt 2. Design Dosage Form 3. Infrastructure Review 4. RX Prep/label / documentation + final review 5. Dispencing & Counseling 6. Post Prep 7. Post dispensing & monitoring
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3
Q

USP 795

A

Pharmaceutical Compounding for NON-STERILE PREPARATIONS simple / moderate / complex

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4
Q

USP 797

A

Pharm Compounding - STERILE preps Low-risk CSP(compounded sterile product) Medium-Risk CSP High Risk CSP

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5
Q

What is included in a Material Record?

A

Ingredient Supplies ID# / Lot# Experiation Date Prepared by? Checked by?

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6
Q

Polar Solvents

A

WATER HIGH polarity/dielectric constant / dipole moment

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7
Q

Non-Polar Solvents

A

Mineral Oil Non-aqueous / non-polar / hydrophobic LOW polarity/dielectric constant/dipole moment

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8
Q

SEMI-Polar Solvents

A

Ethanol / Glycols Propylene Glycol / PEG Miscibile with both water and mineral oil INTERMEDIATE Polarity/dielectric constant / dipole moment

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9
Q

Solution + Surfactant

A

–> Micellar Dispersion

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10
Q

Solution + Insoluble Drug + Surfactant

A

-> Liposome

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11
Q

Solution + Oil + Surfactant

A

-> EMULSIOn

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12
Q

Solution + Insoluble Drug

A

= SUspension

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13
Q

Colloid

A

Insoluble ingredients w/ small particle size ex. Liposomes

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14
Q

Suspensions

A

Insoluble ingredients Ex. Pepto Bismol / Maalox / Calamine lotion

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15
Q

Emulsions

A

O/W or W/ O MAYONNAISE = O/W

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16
Q

Solution Product Components

A
  • API
  • Supporting INACTIVE Ingredients
    • Cosolvent
    • Inactive ingred. to STABILIZE API
      • Buffer system / Chelant (EDTA)
      • Antioxident
    • Inactive ingred > Bioavailability
    • Ingredients for application
  • Inactive ingred for COMPLIANCE
    • Viscosity / flavor / color / fragrance
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17
Q

Components in Syrups

A

API

Sweetener / Flavor / Color

Preservative

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18
Q

COomponents in Elixirs

A

API

ALCOHOL = cosolvent to dissolve drug

Flavor / Color

Preservative

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19
Q

Stokes Law

A

For SUSPENSIONS

The force of viscosity on a small sphere moving through a viscous fluid is given by

APplies to suspensions <2g solids/100ml

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20
Q

Suspension Dosage Forms

A

API

  • Inactive excipients
    • Suspending agent/gelling agent
    • Viscosity enhancer
    • Flocculating Agent
    • ANti-microbial preservatives
    • Buffer system
    • WETTIN AGENT (surfactant/antifoaming)
  • Sweetener/color / fragrance
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21
Q

Thixotrophy

A

Ability to of vehicle to maintain suspension after SHAKING

becomes LESS viscous after SHAKING

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22
Q

Viscosity Increasing Agents

A

Typically for SUSPENSIONS

  • Cellulosics
    • methyl/hypro/HPMC/CMC/
  • Polymers
    • PVP/carbomers/povidone
  • Natural Products
    • ​bentonite/xanthangums
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23
Q

Brownian Motion

A

Applies to partcles <5 microns in size

for inhalation products <1 microns do not need suspending agent

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24
Q

Emulsion Product Components

A
  • API
  • Supporting Active Ingredients
    • Oil to dissolve API
    • Buffer / chelant / antioxidant
  • Emulsifying Agent
  • Aqueous Phase
  • Salts/preservatives
  • Flavor/color/fragrance
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25
Q

SEDDS

A

Self Emulsifying Drug Delivery System

  • Semipolar Solvents
    • ​Ethanol/ PEG400 / propylene glycol
  • Surfactants
    • ​Polysorbate 80
  • Oils
    • Corn/safflire
  • Examples:
    • Cyclosporin / ritonavir / tipranavir
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26
Q

Parenteral Products

A

STERILE / ABSENCE OF PYROGENS

minimal particulates / isotonicity

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27
Q

Adding Surfactant to Solution

Continuously

A

Micelle

Liposome

EMULSION

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28
Q

Anti Area

A

Iso Class 8 Area

for handwashing / garbing / component staging / high particulate activities done here

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29
Q

Iso Class 5

A

Where products are manufactured

ASEPTIC PROCESSING

CRITICAL AREA

lower the number = more clean

  • CLASS 100 (WITHIN LAFW)
  • THE HOOD
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30
Q

Sterilizing Grade Membrane Size

A

0.22 or 0.20 MICRON Pore Size

size that will ertain 100% pseudomonas dimunuta

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31
Q

Positive Pressure Room

A

Higher pressure room than the adjacent room

Net flow of air is OUT of the room

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32
Q

Negative Pressure Room

A

Lower pressure than adjacent room

Net flow of air is INTO THIS ROOM

typically the dirtier room (Iso Class 8)

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33
Q

Needles / Gauge

A

Gauge, HIGHER NUMBER = Smaller diameter

length / bevel

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34
Q

Sterile Filtration

Membrane filter for AIR

A

0.22 - 0.45 Micron filter for AIR

35
Q

USP 800

A

compounding guidelines for

HAZARDOUS DRUGS

handling in healthcare settings

36
Q

Two Primary Objectives

in STERILE Labs

A
  • No Contaimination of Preparation
    • ​Sterility / pyrogenicity
    • Particulate matter / stability
    • Facility design / operation
    • PERSONNEL TRAINING
  • No Human Inhalation / Contact of Drugs
    • ​Garbing / gloves
    • Drug Toxicity
37
Q

ISO 7

A

Buffer Area

CLASS 10k (10,000)

between 8 and 5

38
Q

Filter Straw VS Filter Needle

A

CHOOSE FILTER STRAW

b/c its a straw, you know you have to switch to a regular needle when transfering into the LVP

39
Q

Coring

A

Damage to ubber closure with improper needle technique

prevented w/ anti-coring technique

45-60 degree into the bottle then go straight

40
Q

LAFW Cleaning Direction

A

PERPENDICULAR TO AIRFLOW DIRECTION

Top –> Bottom

Back To Front

41
Q

Heel Technique

A

Technique to remove needle guard from needle / syringe

help prevent needle sticks

42
Q

Definition of Dispersions

A

ARE NOT SOLUTIONS

  • Micelle solutions
  • Colloids
  • Suspensions
  • EMulsions
    • ​BASED ON SIZE OF DISPERSED PHASE
43
Q

Suspensions & Emulsions

A

COARSE Dispersions

Visible particles size >1 micron

44
Q

IV Injection Sizes

A

Liposomes may be injected if small enough

EMULSIONS may be injected if small enough

IV FAT emulsion = 0.4 microns

Nanoparticles

45
Q

Micronization

A

Particle size reduction to ~1micron particle size

  • Done by:
    • micropulverization
    • fluid energy milling
    • jet milling
46
Q

Non-Newtonian Flow

A

Plastic

Pseudoplastic

Dilatant

  • =non linear depends on shear rate
  • RHEOLOGY (study of flow)
47
Q

CAI

Compounding Aseptic Isolator

A

Aseptic Compounding device

AIR GOING INTO ISOLATER MUST PASS THROUGH HEPA FILTER

48
Q

CACI

Compounding Aseptic Containment Isolator

A

Form of CAI

in which air exiting from CAI Passes through HEPA rententive filter

AUTOMATED

49
Q

Isotonicity

A

Important Characteristic of STERILE DOSAGE FORMS

50
Q

Sources of Contamination

A

Bacterial / Fungal / Particulate

MAINLY FROM PEOPLE

water / materials / packaging

51
Q

Considerations for Facility Cleaning

NIH FDA 483

USP 797 Requirements

A

3 bucket system

KNOWLEDGE OF SITE FLORA

know what agents you need to use

52
Q

Sterilization Methods

Thermal

A

Thermal = Moist Heat (STEAM)

Autoclave –> Protein Denaturation

121celcius for 15 min –> destroys bacteria & Spores

& Dry Heat

High temperature 160 celcius

Kills PYROGENS & microorganisms

1 hour dry heat = 15 min moist heat

Works with heat tolerant materials

53
Q

Sterilization Methods

Non-Thermal

A

Radiation & FIltration

Gamma radiation cobalt 60

DNA DESTRUCTION

Drug solution filtration

AIR FILTRATION

54
Q

Sterilization Methods

CHEMICALS

A

Gas & Liquid

Ethylene Oxide

use this when its the first time

55
Q

Testing for Pyrogens

A

LAL = Limulus Amebocyte Test (horseshoe crab

MAT (monocyte activation test)

Rabbit pyrogen test

56
Q

Prevention of Pyrogens

A

Difficult to remove

Removal for high temperature heat

IMPORTANT FOR PYROGENS

57
Q

Sterile Products

Stability

A
  • Chemical
    • ​Unstability in photo / hydrolysis / oxidation
    • or deamination (PH)
  • Physical
    • ​temperature / protein denaturing
    • Aggregation / adsorption
  • Microbial
    • ​PARTICULATES
  • Biopharmaceutic/therapeutic
  • TOXICITY
58
Q

Chemical Stability

A

Also take account for INTERACTIONS w/ packaging​

  • Degradation reactions
    • ​Hydrolysis (pH)
    • Oxidation
    • PHOTO (light) amber glass
    • Stress test
    • deamination
59
Q

Sterile Products

Compatability

A

W/ Bag (ns/d5w)

Administration set

filter

other drugs

Can be ADSORBED into the packaging etc

60
Q

Sterile Products

Isotonicity

A
  • RBC
    • Semipermiable
  • WANT TO BE ISOTONIC
  • HYPERTONIC
    • –> flows out of rbc
  • Hypotonic
    • –> flows IN
61
Q

First Air

A

Unidirectional air that is exiting HEPA FILTER

essentiallly particle Free

62
Q

Low Risk Level CSP

A

All activities with Class 100 (USP 5)

using sterile ingredients

LIMITED INGREDIENTS

FAST PROCEDURE

Simple LVP admixture

63
Q

Medium Risk Level CSP

A

Multiple individual vials are COMBINED

Longer duration

transfers etc.

64
Q

High Risk Level CSP

A

NON-STERILE INGREDIENTS

Powders etc

LONG PROCEDURES

poor air quality

no gowning

65
Q

USP 828

A

RADIOPHARMACEUTICALS

compounded sterile products

66
Q

USP 797

SOPS

Suggested Standard Operating Procedures

A
  • Total of 23 WRITTEN & properly approved SOPs
67
Q

Primary Engineering Control

PEC

A

LAF = LAMINAR AIR FLOW HOOD

ISO CLASS 5

Class 100

Site of compounding

68
Q

USP 797

Personnel

A

Trained

Tested

& Recorded

Forms for the FDA to see if technicians were trained periodically

69
Q

USP 797

Scope of Responsibilities

A
  • Personnel training
  • RX Prep
  • CAREGIVER
  • MONITORING
  • Dispensing & delivery
    • tube systems
70
Q

USP 800

A
  • Handling In Healthcare Settings
    • ​HAZARDOUS DRUGS
  • ​ALL ABOUT YOU BEING PROTECTED
    • nothing to do with the prep
    • or technique
  • Facility / Gowning / Equipment
71
Q

USP 800

Gowning

A

DOUBLE GOWNING

  • Has a hood, covers the face
  • No exposed skin
  • Double booties / double gloves
72
Q

USP 800

Air Flow

A

Negative Air Flow (flow INTO this room) In Buffer room

Air goes into the room –> FILTERED OUT INTO ENVIRONMENT

DO NOT WANT the contaminated air to flow OUT into the rest of the building

ISO 7>7>5 > filtered out of building

73
Q

USP 800

Hood Pressure

A

when we have a negative pressure room (chemo)

HOOD HAS POSITIVE PRESSURE

We want sterile air!!

DO NOT USE A CHEMICAL HOOD

74
Q

USP 800

NIOSH

A

National Institute for OCCUPATIONAL SAFETY & HEALTH

  • Defines Hazardous drugs (LIST)
    • ​Carcinogens / teratogens etc
    • ​ANTINEOPLASTIC –> target cancerous cells
  • Defines Activites with these drugs
    • ​what can come in contact with the hazardous drugs
      *
75
Q

FDA

Insanitary Conditions

FDA 483

A
  • FDA AUDIT for Aseptic practices
    • Watch the gowning
    • Watch for sterilizaton / disinfection
    • Every detail of what you’re doing
    • WILL WATCH TECHNICIANS
76
Q

FDA 503

A

A

Standard Pharmacy

Get an order and Fill for a PATIENT

controlled by state board (797 law requirements for some states)

77
Q

FDA 503

B

A

Making something in advanced

–> SELLING IT

Like Mini Manufacturing

new equipment and have to SCALE UP things

78
Q

Closed System Transfer Device

CSTD

A
  • Two Needles
    • No contact with the air
    • Exchanges Air & Drug
79
Q

Administration Device

A

Very Important for STERILE COMPOUNDING

since everything is in packages

80
Q

STERILE VS Non-STERILE

DIFFERENCES in Dosage forms

A

Most are THE SAME as in non-sterile

  • Main difference is:
    • ​NO flavoring / colors / additives
    • Buffers (mainain PH) / Preservatives
    • Chelating Agents
81
Q

Sterile Products

Special Specification

A

pH

Sterility

Particulates

Preservative Content

Potency

82
Q

Water in Oil emulsion

Dry Gum

4-2-1 Method

A

Method to prepare W/O EMULSION

4 Parts Oil

2 Parts Water

1 Part Emulsifyer

  1. Gum/emulsifyer is LEVIGATED w/ Oil
    1. ​thoroughly wet
  2. Water is added
    1. ​until creamy white
    2. –> CRACKLING sound as it is titrated
83
Q

Wet Gum

English Method

A

4:2:1 Ratio Still

BUT Emulsifying agent –> Water

Oil is then added LAST

84
Q
A

Ceutics Final (5 decks)

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