Formulation of smedds.pptx

Different methods for the development of SMEDDS.

1. Formulation of SMEDDS M egha Assistant Professor

2. Formulation of SMEDDS Screening Of Excipients Construction Of Pseudo ternary Phase Diagram Preparation Of SMEDDS Characterization Of SMEDDS

3. FORMULATION OF SMEDDS

4. 1.Screening Of Excipients A) Solubility studies B) Self emulsification ability By shake flask method Drug + excipient Shaken for 48h at water bath shaker centrifuges and filtrate determine drug content Mixing the equal proportions oil a nd sur fac tant m i x ture + double distilled water The number of flask inversions required to form homogenous emulsion. That indicate self emulsification ability

5. ( 2) Construction of pseudo ternary phase diagram It is useful to identify best emulsification region for microemulsion. These are the diagrams which represent change in phase behavior of the system according to the change in composition. Ternary phase diagram is used to study the phase behavior of three components. in SEDDS, this represents the system with three components like oil, water, and surfactant. In case of SMEDDS, the additional component like cosurfactant/cosolvent addition is most common that is called pseudo ternary phase in which one of the corners corresponds to the mixture of two components like surfactant and cosurfactant . Three corners that correspond to the 100% of the particular component.

6. HO W T O M A KE OR R E A D A T E R N A R Y PH A SE DIAGRAM ? The three corners of the typical ternary diagram represent three components, that is, A, B, and C. Composition at point “O” can be know by the following: Draw a line that is parallel to CB from point O towards AB. The point where this line intersects with AB indicates the percent composition of A at point O(X). Then, percent composition of B at point O can be known by drawing a line that is parallel to AC towards BC. The point where this line intersects with BC indicates the percent composition of B at point O (Y). Similarly, the percent composition of C at point O can be known by drawing a line that is parallel to AB towards AC (Z).

7. PHASE DIAGRAM For four or more components pseudo ternary phase diagrams are used to study the phase behaviour. In this diagram a corner represent a binary mixture of two components such as water/drug, oil/drug or surfactant/co-surfactant. pseudo ternary phase diagram is constructed to find out the different zones of micro emulsion.

8. METHODS ARE USED TO PLOT PSEUDOTERNARY PHASE DIAGRAM 1) Dilution Method Mixture of various composition of surfactant , cosurfactant ,oil Dilute with double distilled water Globule size after dispersion determined by spectroscopy

9. 2 ) W ater titration method Titration of different composition homogenous liquid mixtures of oil + surfactant + cosurfactant with water at room temperature. Stirred at room temperature to attain equilibrium. Visually examined for transparency . After equilibrium was reached. F urth e r t i tr a ted with of dis t i l l e d w a ter unt i l th e y sh o w e d the turbidity. Clear and isotropic samples were deemed to be within the micro- emulsion region. No attempts were made to completely identify the other regions of the phase diagrams.

10. 3 ) M ethods of preparation 1) Phase titration method:- Drug + oil + surfactant + cosurfactant Titration with water Clear dispersion Microemulsion Vortex mixing Vortex mixing

11. 2) Phase inversion method Phase Inversion Temperature (PIT) i.e. at particular the temperature range in which an o/w microemulsion inverts to a w/o microemulsion type or vice versa or by addition of excess dispersed phase.