Kinetics and Stability Studies II Flashcards
Dr. Salako
With three example each, mention 5 types of formulation ingredients
- Diluent e.g. lactose, microcrystalline cellulose, hydrolysed starch, sorbitol, mannitol
- Binders and adhesives e.g. acacia, tragacanth, gelatin, sorbitol, methyl cellulose, starch
- Disintegrants e.g. Primogel, Explotab, Carboxy methyl cellulose (CMC)
- Lubricants e.g. talc, stearic acid, magnesium stearate, PEG
- Glidants e.g. talc, corn starch, syloid, aerosil
- Colouring agents e.g. FD & C yellow 6-sunset yellow, FD &C green 3- Fast Green, D & C red 3- Erythrosine
- Solubilising agents e.g. Captisol (complexing agent), Tween 20 and Tween 80 ( surface active agents)
Provide 2 examples of ‘super’ disintegrants.
They swell up to ten fold within 30 seconds when in contact with water or GIT fluid
e.g. Croscarmellose, Crossprovidone, Sodium starch glycolate
Two forms of colours are used in tablet preparation. They are _________
FD&C and D&C dyes
Mention 3 co-solvents used in formulation.
- Ethanol
- PEG
- Glycerin
Mention 3 tonicity-adjusting agents used in formulation.
- NaCl
- KCl
- Dextrose
- Mannitol
- Sorbitol
Mention 3 buffering agents used in formulation.
- Sodium hydroxide
- Citrates
- Phosphates
- Acetates
CAPS
Mention 3 antioxidants used in formulation.
- Ascorbic acid
- Citric acid
- Tartaric acid
- Sodium metabisulphite
Mention 3 cryoprotectant and lyoprotectant agents used in formulation.
- Sugars
- Glycerols
- Polyols
Note that lyoprotectants protect during the drying stages whereas cryoprotectants protect during the freezing stages.
Mention 3 chelating agents used in formulation.
- Disodium edetate
- Disodium calcium edetate
- Tetrasodium edetate
- EDTA
Mention 3 stabilisers used in formulation.
- Niacinamide
- Creatinine
- Glycerin
- Sodium caprylate
Mention 2 suspending agents used in formulation.
- Gelatin
- Acacia
- Tragacanth
- Bentonite
- PVP
Mention 3 antimicrobial preservatives used in formulation.
- Benzalkonium chloride - 0.01%
- Methyl paraben 0.01 - 0.18%
- Propyl paraben 0.005 - 0.035%
- Phenol 0.065 - 0.5%
- Benzyl alcohol - 0.5-10%
Mention 3 emulsifying agents used in formulation.
- Acacia
- Tragacanth
- Sodium Lauryl Sulphate
What are the 3 types of drug vehicles?
i. Water
ii. Water-miscible vehicles
iii. Non-aqueous vehicles
Mention 7 types of water for pharmaceutical use, as well as their uses, requirement and preparation techniques.
- Purified water: for the preparation of all medications involving water except ampoules, injections and some other external preps.
It must be clear, odourless, colourless, with pH of 5-7.
Preparation technique: filtration, distillation, deionization, reverse osmosis, ion exchange. - Water for Injection: In addition to the requirements of purified water, it must pass the conductivity and total organic carbon (TOC) tests. Bacteria endotoxin level must < 0.25 endotoxin unit per milliliter (FU mL). The microbial level must not be > 10 colony forming units (CFU) per 100 mL.
Preparation technique: Distillation (or reverse osmosis) - Sterile Water for Injection: In addition to previous requirements, it must be sterile, hypotonic, non-pyrogenic, and contain no bacteriostatic or antimicrobial agent. It is supplied only in single dose containers.
Preparation technique: distillation of water for injection (WFI) - Bacteriostatic Water for Injection: Sterile, non-pyrogenic preparation of Water for Injection packaged in multiple dose vials. It contains 0.12 methylparaben, 0.012 propylparaben. pH is 4.5 to 7.0.
It is never to be used for newborns.
Preparation technique: By using sterile water for injection - Sterile water for irrigations: Sterile water for irrigations is water for Injection packaged and sterilised in single-dose containers of larger than 1 L that allow rapid delivery of its contents.
It is used to bath and moisten body tissue, andperforming urologic procedures
Preparation technique: By sterilising water for injection
- Sterile Water for Inhalation:
Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions
Preparation technique: By sterilisation of water for injection - Water for hemodialysis: Water for hemodialysisis used for hemodialysis applications; for the dilution of hemodialysis concentrate solution.
It may be packaged and stored in unreactive containers that preclude bacterial entry.
The water contains no added antimicrobials and is not intended for injection.
Preparation technique: From safe drinking water
