GRANULES Oral Penicillin V Potassium
Provides faster and higher blood levels than
Prepared agglomerates of smaller particle size phenoxymethylpeniclllin
Irregularly shaped and behaved as single
particle CGMP Requirement: Penicillin must be manufactured in
Makes use of sieve #4-12 a separated area from non-penicillin
GRANULATION FORMULA:
Pharmaceutical process which attempts to RAW MATERIAL AMOUNT
convert Phenoxymethylpenicillin 25.0 g
powdered materials into aggregates called Potassium 25.0 g
Carboxymethylcellulose 12.5 g
granules
Sucrose 1.0 g
TWO WAYS OF GRANULATION: Sodium Benzoate 5.0 g
Citric Acid 1.0 g
1. Granulating Machine or Granulator - Allows Strawberry Powder 1.0 g
granulation with or without moisture Lactose, qs ad 300.0 g
2. Wet Granulation - Involves wetting powder
mixture, sieving and drying in preparation of
granules MANUFACTURING PROCEDURES:
1. Mix the powders and blend for 15 minutes
Powder Mix Moist Mass Wet Granules using trituration.
2. Prepare 20 mL colorant solution and spray onto
powder mixture with continuous trituration
Dry Granules Oven Drying until a moist mass is formed.
3. Pass the moist mass through sieve number 12
and receive wet granules in tray.
ADVANTAGES OF GRANULES OVER POWDER:
4. Over dry granules at a temperature not
Faster to dissolve exceeding 40 degrees.
Physically and chemically stable 5. Dry the granules not more than 2% moisture is
Flow properties present. Check moisture content every 30
Seldom form a cake minutes.
6. Weigh and pack the dried granules.
ESSENTIAL ELEMENTS IN LABELING POWDER
GRANULES: SUSPENSIONS
Directions for reconstitution Liquid preparation containing undissolved finely
Shelf-life of reconstitution divided particles evenly distributed in a vehicle.
Label-shake well before use CHARACTERISTICS OF SUSPENSION:
PHENOXYMETHYLPENICILLIN POTASSIUM Pourable, settle slowly, redispersable,
GRANULES FOR ORAL SUSPENSION chemically stable
Penicillin G - Benzylpenicillin REASONS OR ADVANTAGES OF SUSPENSION:
Penicillin V - Phenoxymethylpenicllin
Relatively stable In the presence of gastric Sustaining effect, stability, taste, basic solubility
acidity, soluble in duodenal fluids, orally Availability
effective without buffers Ready to use
Dry powder or granules for suspension in a liquid
vehicle (requires reconstitution)
COMPONENTS OF SUSPENSION: MANUFACTURING PROCEDURE:
Active ingredient 1. Place magnesium hydroxideIn a blender
Wetting agent 2. Add sorbitol
Displaces the air from hydrophobic material 3. Add 100 ml purified water
Allows liquid to surround the particles and 4. Blend the mixture for 5 minutes
provide proper dispersion 5. Add aluminum hydroxide gel. Blend for 5
Surfactant in nature 0.05-0.5% minutes
HLB value 7-9 6. Place CMC in a mortar and triturate with 50 ml
Examples: Glycerin, sorbitol of water until a paste ls formed. Add the
Flocculating agent CMCpaste is formed. Add the CMC paste to the
Added if desired blender
Low concentration of electrolytes (<1%) 7. In a separate container, heat 200 ml of water to
NaCl & KCl –induce flocculation [Link] and dissolve saccharin sodium and
Viscosity agent sodium benzoate. Cool the solution to 4ooc.
Suspending agents or thickeners Charge blender and blend for 10 minutes.
Natural - acacia, Tragacanth 8. Add peppermint oil
Synthetic - derivatives of methylcellulose 9. Homogenize the suspension for 5 minutes
10. Add enough purified water to make the
FOR INTERNAL PREPARATIONS: required volume
Tragacanth and acacia – 1.25 % OINTMENTS
CMC – 2.5 % Semisolid preparations Intended for external
Carbopol 934 –0.3 % application
Easily applied
BUFFERS: Absence of grittiness
Drug has ionizable group to maintain low USES
solubility of drugs
Preservative, tolerant, flavorant 1. Emollient
Vehicle - water, glycerin, sorbitol To make skin more pliable
Smoothening effect
ALUMINUM HYDROXIDE SUSPENSION Protective barrier
Prevent harmful substances from coming
Weak bases that react with gastric HC.L
into contact with skin
Alkali adsorbent that neutralizes or counteracts
Closure of wound
acidity
2. Vehicle
Al(OH)3 + HCl = AlCl3 + H2O
Active ingredient ls incorporated
FORMULA: Ointment bases [non-medicated ointments]
RAW MATERIALS AMOUNT TYPES
Aluminum Hydroxide Gel 7.0%
1. Medicated ointments
Magnesium Hydroxide 3.0%
Ointment base + active Ingredient
Carboxymethylcellulose 2.5%
Saccharin Sodium 0.1% Has therapeutic activity
Peppermint oil 0.1% 2. Non-medicated ointments
Sodium Benzoate 0.1% Vehicles use to carry drug
Sorbitol Solution 70% 20.0% Ointment bases
Purified water, qs ad 100.0%
CLASSIFICATION OF OINTMENT BASES 2. Levigaton
Uniformly disperse active ingredient
1. Oleaginous Bases
throughout the vehicle
Non-water washable, Hydrophobic, greasy
3. Fusion method
used as emollient and/or occlusive
Heating and melting the base
Hydrocarbon bases
Components with high melting points
Solid- paraffinwax
Active medicament readily soluble with the
Semi-solid- Petrolatum / vasellna
melted base
blanca
Liquid mineral oil /liquid petrolatum ANALGESIC OINTMENT
From animal sources
Beeswax, spermaceti Use: To relieve pain
From vegetable origin Mechanism: Sensation of coolness
Fixed oil Method of preparation: Mechanical
2. Absorption (Anhydrous Bases) Incorporation
Ability to absorb water, greasy, non-water
FORMULA:
washable, emollient, occluslve
Wool fat RAW MATERIALS AMOUNT
Anhydrous lanolin, refined wool fat Menthol 2.4 g
Hydrophilic petrolatum Camphor 2.4 g
3. Emulsion Bases Methyl Salicylate 12.0 mL
Water-Ln-Oil Wool fat, qs ad 120.0g
Can contain/absorb water, greasy non
water washable, emollient, occlusive MANUFACTURING PROCEDURE:
Cold cream, lanolin
Oil-In-Water 1. Triturate menthol with camphor.
Water washable, greasy
2. Add ½ portion of total wool amount to the mixture
Can be diluted with water, non - occlusive
and triturate until completely mixed.
Hydrophilic ointment
4. Water Soluble Base 3. Add ½ part of methyl salicylate and ¼ portion of total
Greaseless ointment base, lipid-free, water wool fat amount to the mixture and triturate until
washable, water soluble, usually anhydrous completely mixed
absorbs/contains
4. Add the remaining portion of methyl salicylate and
water
wool fat to the mixture and triturate until completely
Polyethylene glycol ointment
mixed.
FACTORS IN CHOOSING OINTMENT BASE
5. Weigh and pack
Compatibility of the active Ingredient and other
BURN OINTMENT
ingredients
Patient factor Uses: Local anaesthetic, protective
Wet wound (cream) Method of preparation: Fusion
Dry wound (ointment)
FORMULA:
PREPARATION OF OINTMENTS
RAW MATERIALS AMOUNT
1. Mechanical Incorporation Chlorobutanol 2.4 g
Solid/liquid ingredient is incorporated in the Eucalyptus oil 1.68 g
ointment base Zinc oxide 8.76 g
Reduced In Its finest form to prevent Bismuth subnitrate 4.44 g
grittiness White petrolatum 34.8 g
Wool fat 35.16 g
Purified water 32.76 g
MANUFACTURING PROCEDURE:
1. Heat white petrolatum and wool fat until
melted.
2. Blend zinc oxide and bismuth subnitrate by
trituration.
3. In a separate vessel, heat purified water to 80
degrees. Add powder mixture of zinc oxide and
bismuth subnitrate, and mix for 5 minutes
4. Add no. 3 to melted base In no. 1. Mix for 5
minutes and cool to 40 degrees,
5. In a separate vessel, dissolve chlorobutanol in
eucalyptus oil
6. Add chlorobutanol solution to melted base
mixture and mix for 5 minutes.
7. Fill Into ointment tubes.
8. Seal and crimp tubes.