Cream

formulation of cream included in semisolid dosage form

1. CREAM Mr.R.R.Patil Dr.Shivajirao Kadam College of Pharmacy, Kasabe digraj, Sangli.

2. Creams are defines as “a semisolid dosage form containing one or more drug substances dissolved or dispersed in a suitable base ” Creams are semi-solid emulsions of oil and water. They are of a softer consistency & lighter body than true ointment. semisolid emulsions of either O/W or W/O type. INTRODUCTION

3. Oil in Water (O/W) Cream Water in Oil (W/O) Cream TYPES

4. oil-in-water (O/W) creams which are composed of small droplets of oil dispersed in a continuous phase. More comfortable and cosmetically acceptable as they are less greasy and more easily washed off using water . Emulsifying agents of natural origins( bees wax, wool alcohols, wool fat ). Emollient and creamy, white or translucent and stiff . E.g. Vanishing Cream Oil in Water (O/W) Creams

5. water-in-oil (W/O) creams which are composed of small droplets of water dispersed in a continuous oily phase . More difficult to handle but many drugs which are incorporated into creams are hydrophobic and will be released more readily from a W/O cream than an O/W cream. More moisturizing as they provide an oily barrier which reduces water loss from the stratum corneum, the outermost layer of the skin . e.g. Cold Cream Water in Oil (W/O) Creams

6. COSMETIC CREAMS All purpose cream, baby cream, barrier cream, bleaching cream, cleansing cream, cold cream, hair cream, hand cream, vanishing cream . MEDICATED CREAMS Medicated creams are contains active pharmaceutical ingredients. e .g. Cetrimide cream used as antiseptic. Zinc oxide cream used as astringent. Hydrocortisone cream - treat rashes like poison oak or poison ivy

7. 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. MANUFACTURING PROCESS

8. They gives prolong contact in their site of application than any other pharmaceutical semi-solid dosage forms . Injured area can be dried quickly by creams than other semi-solid preparations . Non-irritating when applied to the skin . 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). Advantages of Cream

9. Stability is not as good as ointment . They are less hydrophobic than other semi-solid preparation, so risk of contamination is high than the others. Disadvantage of Cream

10. It should liquefy at body temperature . It should penetrate the epidermis (via natural opening). Its viscosity should be low enough to permit easy spreading. It should be non-toxic. It should be non-irritant. It should be non-inflammatory. Ideal Characteristics

11. pH of the cream Viscosity Rheological behavioral of the cream Determination of type of emulsion i . Dilution test ii. Dye solubility test Evaluation Test

12. The pH of various formulations was determined by using digital pH meter . About 1gm of the cream was weighed and dissolved in 100 ml of distilled water and stored for two hours. The measurement of pH of each formulation was done in triplicate and average values were calculated. pH of the cream

13. Viscosity of the formulation was determined by Brookfield Viscometer. At 20 rpm at a temperature of 25 o C and the determinations were carried out in triplicate and the average of three readings was recorded. Viscosity

14. The rheological property was determined to know the flow behavior of formulation . The viscosity at different rpms was measured using Brookfield viscometer. The rheological behavior of the formulation was studied by taking 100 g of the cream in the beaker . Rheological behavioral of the cream

15. The rate of shear was increased gradually from minimum to maximum and corresponding dial reading was noted; then, the rate of shear was decreased gradually to the lowest value and the dial reading was recorded. The graph was plotted between percent torque and viscosity to determine type of flow.

16. Globule size Phase separation Moisture absorption studies Shelf life Spreadability Stability Test

17. 1 ml of cream was diluted to 10 ml with glycerin. A few drops of this were transferred onto a glass slide and was focused in a microscope . By using eyepiece micrometer , the diameters of 200 particles were determined randomly. Globule size

18. The formulated cream was kept intact in a closed container at 25 - 30 C not exposed to light. Phase separation was observed carefully every 24 hrs for 30 days . Any change in phase separation was checked. Phase separation

19. About 50 mg of cream was taken on a watch glass. A beaker was taken with full of water and was kept in a desiccator without adsorbents. Watch glass with cream was introduced into the desiccator. It was left for 24 hrs. Moisture absorption studies

20. The formulated product was stored in different temperature conditions like room temperature, 45 C and 55 C to accelerate degradation for 1 month . Samples were withdrawn periodically every week and observed for drug decomposition by taking the absorbance under UV spectrophotometer . From the concentrations, and the temperatures, the shelf life of the product can be estimated. Shelf life

21. The Spreadability was expressed in terms of time in seconds. Take two slides to slip off from the cream, placed in between the slides, under certain load . Lesser the time taken for separation of the two slides, better the Spreadability. Spreadability