UNIT 4 - DIAGRAMS Flashcards
High hydrolytic resistance
- More chemically inert than the soda-lime glass.
Alkalinity is removed by using boric oxide to neutralize the oxides of potassium and sodium
- contain strong acid and alkalis as well as all types of solvent
- used for parenteral preparation
- Buffered and unbuffered aqueous solutions.
HIGHLY RESISTANT BOROSILICATE GLASS
(USP TYPE I)
*powdered glass
- High hydrolytic resistance
- Made of commercial soda lime glass
- De-alkalized or treated to remove surface alkali (Sulphur treatment-___________/_________).
- Suitable for acidic and neutral aqueous preparations
- Buffered aqueous solution with pH below 7 (parenteral preparation)
sulphur dioxide/ammonium sulphate
TREATED SODA-LIME GLASS
(USP TYPE II)
* water attack
- Moderate hydrolytic resistance
- Untreated made of commercial soda lime glass
- It is an alkaline glass having high percentage of ______ and ______ and no __________
- Suitable for non-aqueous
preparations - (Dry powder and _________ solution)
Limitation = Not generally used for parenteral preparations
- lime and soda
- boric oxide
- oleaginous
SODA-LIME GLASS
(USP TYPE III)
* powdered glass
- has similar composition to that of type III glass but there is no guarantee of similar properties
- Supplied for Non-parenteral products
- (Tablet, Oral or Topical use)
- Limitation = Not used for parenteral preparations
GENERAL PURPOSE SODA-LIME GLASS
(USP TYPE IV NP)
* powdered glass
types of water for pharmaceutical use
- purified water USP
- water for injection
- sterile water for injection
- bacteriostatic water for injection
- sterile water for inhalation
- sterile water for irrigation
- Prepared by distillation reverse osmosis & same time lon-exchange.
- Used as a solvent in all pharmaceutical preparation except parenteral sterile preparation.
- Also used for all tests & assays of the IP, unless otherwise specified
- Hand washing (in the sterile production)
purified water
- Pyrogen free only ((not more than 0.25 IU of endotoxin per ml)
- Used as a solvent in parenteral preparation
Note: it is not intended to be sterile but should comply with the test for a limit of Endotoxin (Pyrosen free). i.e
it is pyrogen-free but not sterilized as per IP.
- Not contain an added substance
WATER FOR INJECTION
- Sterilised & packed in a single-dose glass container of type
I & II; - maximum. of 1 (one) Litre capacity. i.e both pyrogen-free and sterilized
- Used as a solvent for powder or Injection.
-Not contain an added substance
SWFI
- Sterile WFI contains one or more suitable Bacteriostatic agents & packed in a single or multiple-dose glass container & Maximum 30 mL capacity.
- Contain added substance
BWFI
- it is WFI (Sterilised) & free from an endotoxin
- used in the test for Bacterial Endotoxin (Pyrogen) Test.
water BET
- Distilled water filtered through 0.45m membrane & Conductivity
not more than 0.15 S/cm @ 25 degrees centigrade.
highly purified water
drug discovery and development process
- drug discovery
- preclinical development
- clinical development
- phase I
- phase II
- phase III - regulatory approval
- phase IV
- Target selection
- Lead-finding
- Lead optimisation
- Pharmacological profiling
DRUG DISCOVERY
2.5 years
100 projects
10, 000 compounds screening
- pharmacokinetics
- short-term toxicology
- formulation
- synthesis scale-up
______: in glass
______: in the living
PRECLINICAL DEVELOPMENT
1.5 years
20 compounds
in vitro (cells/molecules)
in vivo (animals)
required standard: 2 mammalian species
- pharmacokinetics
- tolerability
- side-effects in healthy volunteers
PHASE 1 CLINICAL DEVELOPMENT
5-7 years
10
usually 20-80 people
