Suppositories Preparation 193y39

4th semester (E) SESSION 2007-2012

COLLEGE OF PHARMACY

GC UNIVERSITY FAISALABAD

Pharmaceutical unit dosage form

SUPPOSITORIES

DEFINITION

Solid unit dosage form intended for insertion into the body orifices where it melts, softens, or dissolves—and exerts localized or systemic effects

PREPARATION

FOUR METHODS

PREPARATION

METHODS OF PREPARATION Four methods 3. 4. 5. 6.

Molding by hand Compression Pour molding Compression in a tabletting machine

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MOLDING BY HAND

 Hand

molding is useful when we are preparing a small number of suppositories

1. MOLDING BY HAND

STEP 1 drug fine powder

1. MOLDING BY HAND

STEP 2 Drug (fine powder) Base

1. MOLDING BY HAND

STEP 3 Trituration in pestle and mortar

1. MOLDING BY HAND

STEP 4 Mass Rolled Long rods

1. MOLDING BY HAND

STEP 5 Rods cut into pieces

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COMPRESSION MOLDING

 The

cold mass of the base containing the drug is compressed into suppositories using a hand operated machine.

2. COMPRESSION MOLDING STEP 1 drug fine powder

2. COMPRESSION MOLDING

STEP 2 Drug (fine powder) Base

2. COMPRESSION MOLDING

STEP 3 Trituration in pestle and mortar

2. COMPRESSION MOLDING STEP 4 Compress the mixture in the compression mold

ADVANTAGES

1. It is a simple method 2. More elegant than hand molded suppositories. 3. Sedimentation of solids in the base is prevented.

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.

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POUR MOLDING

The melted mass of the base containing the drug is poured into suppository moulds

3. POUR MOLDING

STEP 1 drug fine powder

3. POUR MOLDING

STEP 2 Melt the base

3. POUR MOLDING

STEP 3 Drug incorporation into melted base

3. POUR MOLDING

STEP 4 Cooling down process

3. POUR MOLDING STEP 5

Molds are chilled (lubricate if necessary)

3. POUR MOLDING

STEP 6 Molten liquid mass

chilled molds

3. POUR MOLDING

STEP 7 Warm spatula

3. POUR MOLDING

STEP 8 Removed excessive part via warm spatula

3. POUR MOLDING

STEP 9 After solidification the cone shaped suppositories are removed.

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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.

PRACTICAL PROCEDURE

PRACTICAL PROCEDURE

STEP 1  Given

by physician

Drug quantity e.g., 400 mg zinc oxide Total weight of suppository e.g., 2g No of suppositories e.g., 10 Purpose e.g., For rectal use

STEP 2 Select mold Specific shape and volume

STEP 3 Pour only melted base into mold Solidification excessive removed

STEP 4 melt Check volume of remelted base Confirm average weight of suppository

STEP 5 Check the weight by using formula Mass= density × volume

Calculate total weight of 10 suppositories = 20g

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

STEP 7 Drug Solution into mold

Fill mold with base

Upon solidification Excess

STEP 8 Melt the suppository Homogeneous mixture

STEP 9 pour into the mould Solidification Excessive removed

RESULT  Desired

suppository

Note it is normal practice to prepare for an excess quantity of suppositories

RULES AND PREVENTIONS

SUPPOSITORY PACKAGING

PACKAGING Types of molds of different shapes and volumes  Reusable Stainless steel mold Aluminium mold Brass mold Plastic

 Disposable Soft Plastic molds

PACKAGING Suppositories manufactured in metal moulds Separated from moulds carefully Wrapped individually by aluminium foil Placed in container

PACKAGING Suppositories manufactured in disposable moulds Dispensed to the patient as it is  Note

= It should be easy to release each suppository from mould

PACKAGING In 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

PACKAGING About Containers:  Tightly

closed glass (i.e. glycerin is very hygroscopic)  Individually wrapped foil (Use: Unwrap & insert)

PACKAGING Environmental Factors: Important due to base  High

humidity—absorbs water from atmosphere  Low humidity—loose water to atmosphere--brittle

SUPPOSITORY DISCARD DATES

SUPPOSITORY DISCARD DATES

DISCARD DATES  Discard  If

dates are w.r.t. official data

official data is not available

Discard date = 3 months after manufacturing

SUPPOSITORY LABELLING

LABELLING  In

addition to standard rules for labelling Followings are important to mention

 For

_____ use only

Rectal Vaginal

 Store

below 150C

Questions?

Thanks

Questions?