Pharmaceutical Cream

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Md. Abdur Rashid-12103003Md. Fahim Hasan-12103010Shahnaz Fahmida-12103017 Jinat Jahan Swarna-12103018Md. Rezwan Rahman-12103032Md. Najmul Islam-12103056

NAME OF THE GROUP MEMBERS

DefinitionTypes of CreamPurposes of creamsProperties of an ideal CreamFormulation of CreamIncompatibilityEvaluation of creamPackaging, labeling & Storage of CreamAdvantages of CreamDisadvantages of Cream

Objectives

Creams

A cream is a topical preparation usually for application to the skin. Pharmaceutical creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base.

Creams may also contain suitable antimicrobial or preservatives unless the medicaments or basis have sufficient intrinsic bactericidal and fungicidal activity.

Definition

Creams are of two types: 1. Aqueous creams 2. Oily creams. In case of aqueous creams the emulsions are

oil-in-water type (Vanishing cream),and In case of oily creams emulsions are of water-

in-oil type (Cold cream).

Types of cream

To dried the injured area as soon as possibleTo prevent the irritation, inflammation and

microbial growth of the skin.To prevent infections in some sensitive

organs.To prolong the action in the injured site.To prevent grittiness of the skin. To aid in the retention of moisture

Purposes of creams

Properties of an ideal Cream

Formulation requirement: efficacy, safety, and quality

1.Materials :Active ingredient: Drug or raw materials are used as

active ingredientBase: Base is used as carrier of the drug. Preservative: Preservatives are used to protect the drug

from microbial content.Antioxidant: It is used to prevent oxidation of the drug that

causes degradation.Surfactant: Used to prevent surface tension of two

immiscible phases.Complexing agent: It enhances the stability and prolongs

action.Viscosity enhancer: Decrease the flow property of creams.Humectants: Protect the drug from moisture.  

Formulation of a cream:

2.Process:Preparation of the oil phase: Flake/powder ingredients,

sometimes dry blended in advance, are dispersed into mineral oil or silicone oil. Heating may be required to melt some ingredients.

Hydration of aqueous phase ingredients: Emulsifiers, thickeners and stabilizers are dispersed into water in a separate vessel. Heating may be required to accelerate hydration.

Forming the Emulsion: The two phases are blended under vigorous agitation to form the emulsion.

Dispersion of the active ingredient: The active ingredient often makes up only a small proportion of the formulation; this must be efficiently dispersed to maximize yield and product effectiveness

Formulation of a cream:(continued)

3. Problems:

When added to water, thickening, stabilizing and emulsifying ingredients can form agglomerates which agitators cannot break down.

Similarly oil phase ingredients can form lumps which require shear to disperse.

Ingredients must be fully hydrated to obtain the required viscosity and develop yield.

Partially hydrated materials can build up on the vessel wall, in-tank baffles and parts of the agitator.

Agitators cannot sufficiently reduce droplet size to form a stable emulsion.

Active ingredients can be temperature sensitive. Cooling of the product before

adding the active ingredient further increases processing time. Poor dispersion of the active impairs product effectiveness. Long mixing times and additional equipment may be required to

obtain a homogeneous and stable finished product

Formulation of a cream:(continued)

Incompatibility

Detection of Incompatibility

A developed cream formulation is evaluatedpharmaceutically for various parameters such as:

Rheological properties like apparent viscosity Stability pH External character Spread ability Drug diffusion Stability and primary skin irritation test on animals

and healthy human volunteers

Evaluation of cream

An ideal container should protect the product from the external atmosphere such as heat, humidity, and particulates, be nonreactive with the product components, and be easy to use, light in weight, and economic.Usually creams are packed in metallic collapsible tubes or Plastic containers. Pressurized packages expel the product through a valve.

Comply with the general requirements for labeling and should also specify i)expiry date, and ii) storage conditions.

Creams should be stored at temperature not exceeding 25°C. They should not be allowed to freeze as low temperature can adversely effect the stability of preparation.

Packaging, labeling & Storage of Cream

Easily water washable. Easy to wipe away. Less greasy compared to ointment. Easy to spread on the skin's surface (i.e. easy

to apply). Suitable for sensitive, dry, and fair skin. Suitable for acute lesions. They interfere less with skin functions.Evaporation of water from o/w type of cream

causes cooling sensation.Lower risk of side effect.

Advantages

They are less hydrophobic , so risk of contamination is high than the others.

Less viscous then other semi-solid preparation.

Sometimes rancidification of oils take place.The aqueous phase is prone to the growth of

molds and bacteria hence preservatives should be used.

They contain oil in large amount, some of which are inedible, hence creams are not used for internal use.

Disadvantages

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