Pharmaceutical Creams Overview

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Questions and Answers

What is a key characteristic of creams that makes them susceptible to microbial growth?

  • Emulsification
  • Presence of water (correct)
  • Low pH
  • High viscosity

Which type of cream is known for its ability to promote prolonged contact at the site of application?

  • Lotions
  • Ointments
  • Creams (correct)
  • Gels

What is a disadvantage of using creams compared to ointments?

  • More washable
  • Higher risk of contamination (correct)
  • Less irritating to the skin
  • Faster drying on application

What is another name for oil-in-water (o/w) creams?

<p>Aqueous creams (A)</p> Signup and view all the answers

Which emulsifying agents are commonly used to produce water-in-oil (w/o) creams?

<p>Natural emulsifiers (D)</p> Signup and view all the answers

What is a characteristic of O/W creams according to the miscibility test?

<p>Miscible with water (B)</p> Signup and view all the answers

Which of the following oils is NOT mentioned as a source for vegetable oils?

<p>Sunflower (B)</p> Signup and view all the answers

What type of cream is described as providing good emollient properties but is not readily washable by water?

<p>Cold cream (A)</p> Signup and view all the answers

Which type of oil is primarily described as chemically inert and occlusive?

<p>Mineral oils (paraffins) (D)</p> Signup and view all the answers

What is true about the droplets of O/W emulsions when observed under UV radiation?

<p>They fluoresce (C)</p> Signup and view all the answers

Which of the following statements regarding mineral oils is correct?

<p>They are primarily used for their occlusive nature. (D)</p> Signup and view all the answers

What type of cream typically has a continuous phase that fluoresces?

<p>W/O cream (D)</p> Signup and view all the answers

In which test do O/W creams demonstrate their electrical conduction properties?

<p>Conductivity measurement (C)</p> Signup and view all the answers

Why is it necessary to always make an excess when compounding creams?

<p>To account for potential losses during the compounding process (A)</p> Signup and view all the answers

What is the recommended extra amount to prepare when compounding cream?

<p>10% more than the required amount (B)</p> Signup and view all the answers

What should be checked before preparing the fatty base for cream compounding?

<p>The melting point of the fatty base (C)</p> Signup and view all the answers

At what temperature should the fatty base be cooled before mixing other ingredients?

<p>60ºC (D)</p> Signup and view all the answers

Why might the temperature of the aqueous phase be adjusted to a few degrees higher than the oily phase?

<p>To compensate for the cooling rate of the aqueous phase (B)</p> Signup and view all the answers

What is the concentration range for Butylated Hydroxyanisole as an antioxidant?

<p>0.02~0.5% w/w (B)</p> Signup and view all the answers

Which of the following is NOT a recommended humectant for creams?

<p>Sodium metabisulphite (B)</p> Signup and view all the answers

What is the primary purpose of levigation in cream compounding?

<p>To incorporate insoluble coarse powders (D)</p> Signup and view all the answers

At what temperature range is mixing by fusion typically performed when making ointments?

<p>60~70°C (D)</p> Signup and view all the answers

Which term refers to the process of grinding powders to mix them into a base?

<p>Trituration (A)</p> Signup and view all the answers

What is the maximum recommended concentration of sodium metabisulphite as an antioxidant?

<p>1% w/v (D)</p> Signup and view all the answers

Why is hygiene emphasized in the process of compounding creams?

<p>To avoid contamination (B)</p> Signup and view all the answers

Which of the following is involved in the 'doubling up' technique during trituration?

<p>Incorporating powders into a base (D)</p> Signup and view all the answers

What is the appropriate temperature to add the disperse phase when making creams?

<p>60°C (C)</p> Signup and view all the answers

How should the emulsion be stirred during the preparation of the cream?

<p>Continuously without incorporating air (D)</p> Signup and view all the answers

What can be a consequence of hastening the cooling process during cream preparation?

<p>Poor product consistency (C)</p> Signup and view all the answers

What is the primary role of the cetrimide in the Dimethicone cream formulation?

<p>Preservative (D)</p> Signup and view all the answers

What is the total weight of the oily phase in the Dimethicone cream formula?

<p>505 g (C)</p> Signup and view all the answers

What type of cream is being prepared according to the master formula provided?

<p>Oil-in-water (o/w) cream (A)</p> Signup and view all the answers

Which ingredient in the formulation serves as a thickening agent?

<p>Cetostearyl Alcohol (B)</p> Signup and view all the answers

What should one avoid while stirring the emulsion during cream preparation?

<p>Incorporating air (C)</p> Signup and view all the answers

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Study Notes

Creams

  • Viscous semisolid emulsions for external use only
  • Susceptible to microbial growth due to the presence of water
  • Consists of medicaments which can be dissolved or suspended in either oil-in-water or water-in-oil cream base

Advantages of Creams

  • Prolonged contact at the application site
  • Non-sticky and easily washable
  • Non-irritating on application to the skin
  • Dry the injured area more quickly than ointment

Disadvantages of Creams

  • Less hydrophobic, hence higher risk of contamination

Oil-in-water (o/w) Creams

  • Also known as aqueous cream or vanishing cream
  • Produced by synthetic waxes (e.g. macrogol, cetomacrogol)
  • Thin, white, and smooth in consistency
  • Water washable base for rapid absorption and penetration of drugs
  • Examples: aqueous cream, cosmetic creams

Water-in-oil (w/o) Creams

  • Also known as oily cream
  • Produced by natural emulsifiers (e.g. beeswax, wool fat or wool alcohols)
  • Creamy, white or translucent, and rather stiff
  • Provide good emollient properties; not readily washable by water; gives a cooling sensation
  • Examples: Cold cream

Distinguishing between O/W and W/O Cream

  • Miscibility Test: O/W creams are miscible with water, while W/O creams are miscible with oil
  • Microscopic Examination: O/W creams have colored droplets after staining with an oil-soluble dye, while W/O have colored backgrounds
  • Microscopic Observation under UV radiation: O/W creams have droplets that fluoresce, while W/O creams have continuous phases that fluoresce
  • Conductivity Measurement: O/W creams are conductors of electricity, while W/O creams are poor conductors

Oily Vehicles

  • Mineral oils (paraffins): most widely used, complex mixtures of saturated hydrocarbons; occlusive; chemically inert; do not give good skin penetration
  • Vegetable oils: plant sources (e.g. peanut, castor, olive and coconut); occlusive; give good skin penetration
  • Synthetic oils

Mineral Oils (Paraffins)

  • Commonly used types include soft paraffins, liquid paraffins, and hard paraffins
  • White soft paraffin and yellow soft paraffin are used to thin or thicken products
  • The choice of paraffin depends on the colors of the ingredients

Vegetable Oils

  • Oxidation can be controlled by adding antioxidants such as:
    • Butylated hydroxyanisole (0.02~0.5% w/w)
    • Butylated hydroxytoluene (0.02~0.5% w/w)
    • Sodium metabisulphite (0.01~1% w/v)
    • Sodium sulphite (0.1% w/v)

Humectants

  • Hydroscopic materials added to decrease water loss from creams
  • Used at concentrations of 5 - 15%
  • Examples: Glycerol (glycerin), Propylene glycol, Polyethylene glycol 300

Compounding Creams: Terminologies

  • Mixing by Fusion: Melting together the fatty bases over a water bath before incorporating other ingredients
  • Trituration: Incorporation into the base of finely divided insoluble powders or liquids
  • Levigation: Incorporation of insoluble coarse powders into a base using a shearing force to avoid a gritty product

General Principles of Compounding Creams

  • Hygiene: Clean all surfaces, spatulas, and equipment with ethanol
  • Always make an excess: Make 2-4g extra to account for loss during the compounding process
  • Check solubility: Determine which ingredients are soluble or miscible in the aqueous phase and which are soluble or miscible in the oily phase
  • Prepare the fatty base: Melt the fatty base in an evaporating dish over a water bath at the lowest possible temperature; cool the fatty base to 60°C; add and mix other ingredients that are soluble/miscible with the oily phase
  • Prepare the aqueous phase: Heat up the aqueous phase to 60°C; dissolve water-soluble ingredients in the aqueous phase
  • Add disperse phase to continuous phase at the same temperature (60°C):
    • For O/W cream: pour oily phase into aqueous phase
    • For W/O cream: pour aqueous phase into oily phase
  • Stir continuously to mix: Stir the resulting emulsion continuously, but not too vigorously, until the product sets.

Hospital Manufacturing Unit

  • Make sure to follow aseptic techniques and maintain hygiene in the lab

Dimethicone Cream BPC 1973 (Master Formula)

  • Liquid Paraffin BP (400g) - Oily phase
  • Dimethicone 350 BP (100g) - Miscible with oily phase
  • Cetrimide BP (5g) - Emulsifying wax
  • Cetostearyl Alcohol BP (50g) - Emulsifying wax
  • Chlorocresol (1g) - Preservative
  • Freshly boiled and cooled purified water (444g) - Aqueous phase
  • This is an o/w cream base

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