8-Gels and Suppositories

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GELS AND

SUPPOSITORIES
Nourish your
knowledge GENERAL NOTES
• Gels: are semisolid pharmaceutical dosage forms, aqueous colloidal suspension of the hydrated forms of insoluble
medicaments, Intended for external use.
• They consist of at least 25% of the active ingredient solid as fine powder, mixed with a suitable, usually fatty, base.
• Jellies: are transparent, non-greasy semisolid gels applied externally.
• Uses of jellies:
1. Medication: vehicle for water soluble drugs; local anesthetics, antiseptics.
2. Lubrication: for catheters  items for electro-diagnostic equipment  cytoscopes and rubber gloves
3. Miscellaneous uses.
• Suppositories: are medicated solids dosage forms generally intended for use in the rectum, vagina and to lesser extent in the
urethra. Usually employ a base that melt or soften at body temperature.
• Suppositories can be:
1. Medicated
1. local effect (astringent)
2. systemic effect (analgesic, anti-inflammatory, …)
2. Non-medicated: laxative effect in the rectum
LUBRICATING JELLY
• Use of whole preparation: lubricating rubber gloves or finger stalls for rectal examination

Ingredients M.F Use

Sodium carboxy methyl cellulose 5.0g Jelling agent

Glycerol 15.0g humectant, hygroscopic

Methyl hydroxybenzoate 0.1g Preservative

Patent blue V 0.001g Although advisable, it is no essential for rectal lubricants to be sterile. But, if they are not,
it is useful to include a dye as a warning that the preparation is unsuitable for
lubrication articles used for sterile regions in the body.

Purified water (up to) 100.0g


• In your report, make calculations for 50.0g
GENERAL NOTES
Ingredient Notes
Sodium carboxy methyl cellulose Jelling agent
(S.C.M.C) Cellulose derivatives are widely used because:
1. It provides natural jellies of very stable viscosity.
2. They resist microbial attack.
3. Produce jellies with high clarity (they are free from insoluble impurities)
4. Produce a strong film when dried on the skin
Added in two proportions:
5. 33% of high viscosity.
6. 67% of low viscosity.

Methyl hydroxybenzoate Preservative, it has to be compatible with the jelling agent.


Na.C.M.C is compatible with:
1. 0.2% w/v methyl hydroxybenzoate
2. 0.02% w/v propyl hydroxybenzoate

Glycerol Humectant, hygroscopic: prevent dehydration of the product.

Container and storage: collapsible tube


 well filled: to minimize evaporation of water into air spaces that encourages microbial growth
 well-closed and cool place: to prevent drying out of the preparation
PROCEDURE:
1. Weigh the high grade viscosity and the low grade viscosity of S.C.M.C.
2. Mix the S.C.M.C with glycerin in a glass mortar. Levigate until you get a smooth paste.
3. Add water in small amounts and stir until a clear gel is formed.
4. Pack in a container (collapsible tube).

In your report, make a full label.


SUPPOSITORIES

• Types of suppositories:
• According to their shape:
1. Torpedo  rectal suppositories
2. Oviform  vaginal suppositories
3. Pencil shape  urethral suppositories
• According to their size:
1. adult`s supp. = 2g
2. Children`s supp. = 1g

• Suppositories bases:
1. Fatty bases: these melt at body temperature, ex: theobroma oil (coconut butter), witepsol.
2. Water soluble bases: these dissolve or disperse in the secretions of the body cavity in which they are
inserted, ex: glycerogelatin bases, macrogols (PEG)
Why rectal suppositories are utilized for
systemic actions?
1. The patient suffers from nausea or vomiting.
2. Postoperative, when patient may be unconscious or not able toingest a drug orally.
3. Mentally disturbed people.
4. Very old or very young.
5. When oral intake results in gastrointestinal side effects as irritations or ulcers.
6. When the drug is insufficiently stable at the pH of the GIT or during the first passage through the liver after
absorption.
7. Some drugs that are candidates for abuse, as suicide are formulated as suppositories.
8. Drugs with unacceptable taste can be administered rectally without this inconvenience.
PARACETAMOL SUPPOSITORIES:

Ingredients M.F Use


Paracetamol 0.125g/supp. Analgesic, antipyretic
Displacement value= 1.4  the number of parts by weight of the
medicament that displaces one part by weight of the base
1.4g paracetamol  1g base
Cocoa butter Natural fatty acid base
(theobroma oil)
Witepsol ad. Synthetic fatty acid base
calculate for 10 suppositories and Moulds capacity= 1g theobroma oil
dispense 6 suppositories
CALCULATIONS
• Paracetamol: 0.125g/supp.
• 0.125  supp.
• ??? 10 supp. ??? = 1.25g
• Displacement value = 1.4g
(each 1.4g paracetamol will displace 1g of base)
• 1.4  1
• 1.25  ??? ??? = 0.89g
• Base (cocoa butter and witepsol)
• 10g – 0.89 = 9.1g
• 50% of the base is cocoa butter, 50% of the base is witepsol = 4.55g
PROCEDURE
1. Lubricate the mold with few drops oil.
2. Cool the lubricated mold over ice to hasten setting of the supp. And thus decrease rate of sedimentation.
3. Melt theobroma oil and witepsol (30-36°C) in a basin over water bath.
4. Weigh paracetamol in another basin.
5. Add half amount of the melted base to paracetamol and levigate well with a blade spatula to get a smooth paste.
6. If the mass is solidified return to water bath to re-melt with minimum heat to start moving the base, when the mixture in the
basin has cooled sufficiently and starts to thicken and flows sluggishly, pour the mixture into the holes of the moulds
continuously filling each to an over fill and stirring the contents between pouring.
 Pour when the base thicken and while stirring: to decrease rate of sedimentation of insoluble medicament.
 Pou continuously: to prevent layering and incorporation of bubbles.
 Over fill: to prevent depression at the top of the supp. To contraction on cooling (prevent pinholing).

7. Place the mould in ice and when surplus material has attained the consistence of the butter (2-3min), remove it cleanly with a
sharp blade spatula over a paper.
8. When the supp. Have completelyst hard, eject by pressure on the broad ends.
9. Remove any surplus on the surface, by rolling on filter paper.
10. Pack in plastic jar

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