preparation
DESCRIPTION
PREPARATION . METHODS OF PREPARATION. Four methods Molding by hand Compression Pour molding Compression in a tabletting machine. MOLDING BY HAND. Hand molding is useful when we are preparing a small number of suppositories. MOLDING BY HAND. STEP 1. drug fine powder. MOLDING BY HAND. - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/1.jpg)
PREPARATION
![Page 2: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/2.jpg)
METHODS OF PREPARATION
Four methods
1. Molding by hand2. Compression3. Pour molding4. Compression in a tabletting machine
![Page 3: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/3.jpg)
1. MOLDING BY HAND
Hand molding is useful when we arepreparing a small number of
suppositories
![Page 4: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/4.jpg)
STEP 1 drug
fine powder
1. MOLDING BY HAND
![Page 5: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/5.jpg)
STEP 2Drug (fine powder)
Base
1. MOLDING BY HAND
![Page 6: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/6.jpg)
STEP 3Trituration
in pestle and mortar
1. MOLDING BY HAND
![Page 7: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/7.jpg)
STEP 4Mass
Rolled
Long rods
1. MOLDING BY HAND
![Page 8: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/8.jpg)
STEP 5Rods
cut into pieces
1. MOLDING BY HAND
![Page 9: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/9.jpg)
2. COMPRESSION MOLDING
The cold mass of the base containingthe drug is compressed into
suppositories using a hand operated machine.
![Page 10: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/10.jpg)
STEP 1 drug
fine powder
2. COMPRESSION MOLDING
![Page 11: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/11.jpg)
STEP 2Drug (fine powder)
Base
2. COMPRESSION MOLDING
![Page 12: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/12.jpg)
STEP 3Trituration
in pestle and mortar
2. COMPRESSION MOLDING
![Page 13: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/13.jpg)
STEP 4Compress the mixture in the
compression mold
2. COMPRESSION MOLDING
![Page 14: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/14.jpg)
ADVANTAGES
1. It is a simple method2. More elegant than hand molded
suppositories.3. Sedimentation of solids in the base is
prevented.
![Page 15: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/15.jpg)
DISADVANTAGES
1. Air entrapment may take place.2. This air may cause weight variation.3. The drug and/or the base may be
oxidized by this air.
![Page 16: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/16.jpg)
3. POUR MOLDING
The melted mass of the base containingthe drug is poured into suppository
moulds
![Page 17: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/17.jpg)
STEP 1 drug
fine powder
3. POUR MOLDING
![Page 18: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/18.jpg)
STEP 2
Melt the base
3. POUR MOLDING
![Page 19: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/19.jpg)
STEP 3
Drug incorporation into melted base
3. POUR MOLDING
![Page 20: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/20.jpg)
STEP 4
Cooling down process
3. POUR MOLDING
![Page 21: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/21.jpg)
STEP 5Molds are chilled
(lubricate if necessary)
3. POUR MOLDING
![Page 22: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/22.jpg)
STEP 6Molten liquid mass
chilled molds
3. POUR MOLDING
![Page 23: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/23.jpg)
STEP 7
Warm spatula
3. POUR MOLDING
![Page 24: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/24.jpg)
STEP 8
Removed excessive part via
warm spatula
3. POUR MOLDING
![Page 25: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/25.jpg)
STEP 9
After solidification the cone shapedsuppositories are
removed.
3. POUR MOLDING
![Page 26: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/26.jpg)
4. AUTOMATIC MOLDING MACHINE
In industry all the operations in pour molding are done by automatic machines.
Using this machine, up to about 10,000 suppositories per hour can be produced.
![Page 27: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/27.jpg)
PRACTICAL PROCEDURE
![Page 28: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/28.jpg)
STEP 1
Given by physicianDrug quantity e.g., 400 mg zinc oxideTotal weight of suppository e.g., 2gNo of suppositories e.g., 10Purpose e.g., For rectal use
![Page 29: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/29.jpg)
STEP 2Select mold
Specific shape and volume
![Page 30: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/30.jpg)
STEP 3Pour only melted base into mold
Solidification
excessive removed
![Page 31: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/31.jpg)
STEP 4melt
Check volume of remelted base
Confirm average weight of suppository
![Page 32: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/32.jpg)
STEP 5Check the weight by
using formulaMass= density × volume
Calculate total weight of 10 suppositories
= 20g
![Page 33: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/33.jpg)
STEP 6
Displacement value of drug to the base e.g., 4.7g of ZnO= 1g of cocoa butter
Means 400mg × 10 = 0.85 g of base
Volume of base needed = 20g-0.85=19.15g
![Page 34: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/34.jpg)
STEP 7Drug Solution into mold
Fill mold with base
Upon solidification Excess removed
![Page 35: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/35.jpg)
STEP 8Melt the suppository
Homogeneous mixture
![Page 36: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/36.jpg)
STEP 9pour into the mould
Solidification
Excessive removed
![Page 37: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/37.jpg)
RESULT
Desired suppository
Note it is normal practice to prepare for an
excess quantity of suppositories
![Page 38: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/38.jpg)
SUPPOSITORY PACKAGING
RULES AND PREVENTIONS
![Page 39: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/39.jpg)
PACKAGINGTypes of molds of different shapes and
volumes Reusable
Stainless steel moldAluminium moldBrass moldPlastic
DisposableSoft Plastic molds
![Page 40: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/40.jpg)
PACKAGINGSuppositories manufactured in metal
moulds
Separated from moulds carefully
Wrapped individually by aluminium foil
Placed in container
![Page 41: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/41.jpg)
![Page 42: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/42.jpg)
PACKAGINGSuppositories manufactured in disposable
moulds
Dispensed to the patient as it is
Note = It should be easy to release each suppository from mould
![Page 43: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/43.jpg)
![Page 44: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/44.jpg)
PACKAGINGIn General:
Best to keep all suppositories refrigerated
Base of Cocoa Butter: Store < 30oC
Base of glycerinated gelatin: Store <35oC
Base of PEG: High m.p. so usually OK slightly warm
![Page 45: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/45.jpg)
PACKAGING
About Containers:
Tightly closed glass(i.e. glycerin is very hygroscopic)
Individually wrapped foil (Use: Unwrap & insert)
![Page 46: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/46.jpg)
PACKAGING
Environmental Factors:Important due to base
High humidity—absorbs water from atmosphere
Low humidity—loose water to atmosphere--brittle
![Page 47: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/47.jpg)
SUPPOSITORYDISCARD DATES
![Page 48: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/48.jpg)
DISCARD DATES
Discard dates are w.r.t. official data
If official data is not available
Discard date = 3 months after manufacturing
![Page 49: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/49.jpg)
SUPPOSITORY LABELLING
![Page 50: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/50.jpg)
LABELLING In addition to standard rules for labelling
Followings are important to mention
For _____ use onlyRectalVaginal
Store below 150C
![Page 51: PREPARATION](https://reader035.vdocuments.net/reader035/viewer/2022062501/568165c1550346895dd8c75f/html5/thumbnails/51.jpg)
Questions?Thanks