Suppositories and Inserts Flashcards
What are the some fatty oleaginous bases
coca butter
hydrogenated fatty acids of vegetable oils-cottonseed oil and palm kernel oil
glycerin + high molecular weight fatty acids: examples are glyceryl monosterate and glyceryl monopalmitate
What is cocoa butter NF
- the triglyceride fat from roasted seed of Therobroma cacoa
- 40% of fatty acid is unsaturated; melts at 30-36 degrees C; solid @ room temperature
- polymorphism; can form a metastable form that melts at room temp and won’t solidify @ room temp.
- used beewax 4% if drugs lower melting point
- Fattibase, Wecobee base, Witepsol base
What is glycerinated gelatin
Made by dissolving gelatin 20% in glycerin 70% and adding a solution containing drug which is 10%
Melt and mix fluids slower, slower release
Used for vaginal suppositories not for rectal
Hygroscopic protect from moisture to maintain shape
Local irrational upon insertion; moisten before insertion
Used for urethral suppositories at different ratios (60% gelatin, 20% glycerin, and 20% drug)
What is polyethylene glycols
Fusion of two types for desired suppository base
Don’t melt at body temp, dissolve in body fluid
Release drug at slower rate, no refrigeration
Contain less than 20% water; need to be dipped in water
What are miscellaneous bases
Polyoxyl 40 sterate
What is polycyclic 40 sterate
A surface active agent with several bases to form a water in oil emulsion that disperses in aqueous fluids
Increase drug absorption and interacts with active ingredient
What temp are cocoa butter suppositories stored at
2-8 degrees C, refrigerator
How are glycerinated gelatin and PEG suppositories stored
At 20-25 degrees celcius
What is liquefaction time
The time required for a suppository to liquefy under pressure similar to conditions in rectum which is about 37 degrees C it should be less than 30 min
What is the mechanical strength/crushing test
It is used to measure the mass in kilograms that a suppository can stand without breaking
Should be 1.8-2kg of pressure
Performed to verify that the suppository can be transported under normal conditions, and administered to patient
Describe the steps of determining content uniformity
- Use 10 units, with the range of 85 to 115% of label claim it passes
- If not but no unit is beyond 75 to 125 % of label test 20 more units
- One unit of thirty is in first range and none or out side of second range pass
- If not reject
Paraguard, duramed(non hormonal)
A t shapes copper contraceptive, gives 10 years of contraception; intrauterine device
Progestasert
A progesterone intrauterine device, releases drug for a year
Mirena(hormonal)
Intrauterine device; releases a small amount of levonorgestrel into uterus, contraception for 5 years
Estring
Intravaginal ring; treatment of postmenopausal vagina atrophy
Estradiol is released continuously for 3 months
