Exercise 23: Sulfur Ointment

IP 141 Laboratory
Ayran, C.M.G.

Gels
Exercise 23: Sulfur Ointment (SO)
Ansel: pp. 127, 249-251
Remington: pp. 856-857, 1565-1566
 Semisolid systems consisting of dispersions of
small or large molecules in an aqueous or liquid
- Sulfur Ointment, USP vehicle rendered jelly like by addition of gelling
- Lac Sulfuris Ointment, Milk of Sulfur Ointment agent
- Active parasiticide, treatment for Sarcoptes
scabiei (mites) Plasters
- Active keratolytic
 Solid or semisolid adhesive masses spread upon
- Used in the treatment of skin disorders such as
a backing material of paper, fabric, moleskin, or
psoriasis, seborrhea, eczema-dermatitis, and
plastic
lupus erythematosus
- Prolonged use may result in a characteristic  Adhesive material: Rubber base or synthetic
dermatitis venenata resin
 Applied to skin for prolonged contact at the site
 Ex. Salicylic Acid Plaster
Ointments, Creams, and Pastes
Semisolid preparations in which the drug is contained in a Glycerogelatins
suitable base (ointment base), which is itself semisolid and
either hydrophilic or hydrophobic in character  Plastic masses containing gelatin (15%), glycerine
(40%), water (35%), and an additional medicinal
Ointments substance (10%) as zinc oxide
 Applied to skin for long-term residence
 Simple mixtures of drug substances in an  Ex. Zinc Gelatin, USP (for treatment of varicose
ointment base ulcers, also known as “zinc gelatin boot” due to
 Preferred when therapeutic action is desired its ability to form a pressure bandage”

Cataplasms
Creams
 Also called poultices
 Semisolid emulsions that are less viscid and  Soft, moist mass of meal, herbs, seeds, etc.,
lighter than ointments usually applied hot in cloth
 Semisolid preparations containing one or more  Consistency is gruel-like
medicinal agents dissolved or dispersed in either  Intended to localize infectious material in the
an O/W emulsion or another type of water- body or to act as counterirritants
washable base  Ex. Kaolin Poultice NF IX
 Greater aesthetic appeal due to their non-greasy
character and their ability to “vanish” into the Powders
skin upon rubbing
 So-called “vanishing creams” are O/W emulsion  Powders for external use are called dusting
containing large percentage of water and stearic powders
acid  Usually contain starch, talc, and zinc stearate
 Easier to spread and remove than ointment  Ex. Absorbable Dusting Powder USP (lubricant
 Preferred when therapeutic action is desired for surgical gloves)

Pastes Dressings

 Contain more solid materials(25%) than do  External applications resembling ointments,

ointments and are therefore stiffer and less usually used as a covering or protection
penetrating  Usually as a topical anti-bacterials
 Usually employed for protective action and for  Ex. Petrolatum Gauze
their ability to absorb serous discharges from
skin lesions Contraceptives
 Preferred when protective action is desired
 In the form of creams, jellies, or aerosol forms
 Ex. Zinc Oxide Paste, USP and
intended for vaginal use to protect against
Carboxymethylcellulose Sodium Paste
pregnancy

Exercise 23: Sulfur Ointment, USP Page 1

 Exercise 23: Sulfur Ointment
IP 141 Laboratory
Ayran, C.M.G.

 Contraceptive creams and jellies are designed to Prescribed USP Tests for Ointments:
melt or spread, following insertion, over the
vaginal surfaces 1. Microbial Content
 Agents to immobilize spermatozoa  Antimicrobial preservatives:
 May contain spermicidal agents, pH of 3.5 or less a. Examples are: Methylparaben,
Propylparaben, Phenols, Benzoic Acid,
Preparation of 3g Sulfur Ointment Sorbic Acid, and Quaternary ammonium
salts
Precipitated Sulfur: 0.3g (100g) b. Should be effective at relatively low
Mineral Oil: 0.3g (100g) concentrations against a broad spectrum of
White Ointment: 2.4g (800g) variety of microorganisms that could cause
disease or product deterioration
Uses of Ingredients: c. Should be soluble in required
concentrations
Precipitated Sulfur d. Should be nontoxic, nonsensitizing at in-use
concentrations
 Active ingredient e. Should be compatible with ingredients of
 Parasiticide the formulation and package components
f. Should be free from objectionable odors
Mineral Oil and colors
g. Should be stable over a wide spectrum of
 Levigating agent, intervening reagent used to conditions
reduce the particle size of gritty powders h. Should be inexpensive
 SG: 0.845-0.905  Absence of Staphylococcus aureus and
Pseudomonas aeruginosa (have the capacity to
White Ointment infect skin)
 Involves testing of raw materials
 Oleaginous base  Use of acceptable waters
 Rectal, urethral, and vaginal ointments should be
Preparation of Precipitated Sulfur:
tested for the presence of yeasts and molds
To a slurry of 1 part of lime and 10 parts of water, 2 parts
2. Minimum Fill
of sublimed sulphur are added, thoroughly mixed and the
 Involves the determination of net weight or
mixture boiled with frequent agitation until all the sulphur
volume of the components of filled containers to
is dissolved:
assure proper contents compared with the
12S + 3Ca(OH)2  3CaS5 + CaS2O3 + 3H2O labelled amount

After cooling, the clear liquid is decanted through a filter, 3. Additional Standards
and a slight excess of HCl, calculated form the quantity of  Manufactures often examine semisolid
lime used, is added to the filtrate. The acid decomposes preparations for viscosity and for in vitro drug
the calcium pentasulfide and the thiosulfate with the release to ensure intralot and lot-to-lot
precipitation of sulphur: uniformity
 In vitro drug release tests involve diffusion cell
2CaS5 + CaS2O3 + 6HCl  3CaCl2 +12S↓ + 3H2O studies to determine the drug’s release profile
from the semisolid product
Precipitated Sulfur VS Sublimed Sulfur
Packaging
Precipitated Sulfur has smaller particle size, therefore
more reactive so it is used as keratolytic. Sublimed sulphur  Can be placed in ointment jars or in metal or
is usually used as cathartic plastic ointment tubes
 Ointment jars are available in one-half to 16-oz
sizes; tubes are available from 3.5g capacity
(often ophthalmic) to 4-oz

Exercise 23: Sulfur Ointment, USP Page 2

 Exercise 23: Sulfur Ointment
IP 141 Laboratory
Ayran, C.M.G.

Quality Control Packaging Requirement: Preserve in well-closed

container; avoid prolonged
Appearance: Yellow homogeneous solid exposure to excessive heat

Weight: 3g Label: For external use only

Texture-surface: Smooth; non-gritty Container: Plastic Ointment Jar

Texture-spatula spread: Smooth; non-gritty Cap: Plastic ointment jar cover

Overall feel: Comments:

Greasiness: Greasy  Coalescence: phases come together

 Rancidity: decomposition of the oil phase of the
Water-washability: Not water-washable ointment
 Place in a cool place to protect against
Stiffness: Slightly stiff separation due to heat
 When required, light-sensitive preparations are
Solids content: Moderate amount of solid
packaged in opaque or light-resistant containers
present
 Label should include the type of base used (e.g.
Physical Instability: Bleeding, change in water-soluble or water-insoluble)
consistency, coalescence,  Jars and tubes are first tested for stability and
rancidity, drying out compatibility; stability testing of filled containers
at room temperature (70oF) and under
accelerated stability testing condition (105-
120oF)

Minimum Fill (USP)

Exercise 23: Sulfur Ointment, USP Page 3

 Exercise 23: Sulfur Ointment
IP 141 Laboratory
Ayran, C.M.G.

Schematic Diagram and RFIS: Geometric Dilution is used to ensure proper and
equal dispersion of the active ingredient
Method used: Incorporation throughout the product, it is also used for potent
1. Levigate the 0.3g Sulphur with 0.3g/0.2625mL drugs
Mineral oil to a smooth paste
0.6g Sulfur Paste + 0.6g White Ointment
2. Incorporate with the 2.4g white ointment 1.2g Sulfur Paste + 1.2g White Ointment
Why? 2.4g Sulfur Paste + 0.6g White Ointment

Exercise 23: Sulfur Ointment, USP Page 4