1. By
Mr. Meghraj Suryawanshi
(First Year M-Pharmacy)
2016-2017
Department of Pharmaceutics
R. C. Patel Institute of Pharmaceutical Education and
Research,
Shirpur-425405
DISSOLUTION MEDIA
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2. CONTENT
 INTRODUCTION
 SELETION OF DISSOLUTION MEDIA
 TYPES OF DISSOLUTION MEDIA
 COMPOSITION OF DISSOLUTION MEDIA
 FACTORS AFFECTING DISSOLUTION MEDIA
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3. INTRODUCTION
 Solubility is defined as the concentration of the solute in a
saturated solution at specified condition.
 The drug solubility in solution is static property and drug
dissolution rate is dynamic property.
 Solubility is one of the important parameters to achieve desired
concentration of drug in systemic circulation for achieving
pharmacological response.
 Currently only 8% of new drug candidates have both high
solubility and permeability.
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4. INTRODUCTION
 Dissolution is the process by which a solid substance enters the
solvent phase to yield a solution i.e. mass transfer from solid surface
to liquid phase.
 Importance of Dissolution:
 Dissolution testing is mainly used to confirm product quality and
batch-to-batch consistency.
 In vitro dissolution testing is important in the case of poorly
water/aqueous soluble drug, where absorption and therapeutic
effects of drug depends on dissolution of drug in the medium.
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5. INTRODUCTION
 It is useful in product development.
 It is useful in selection of excipients.
 It is used to study rate of dissolution of drug.
 It is useful to interpreted solubility of poorly water soluble
drug
 It is useful optimizing manufacturing process.
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6. SELECTION OF DISSOLUTION MEDIA
 The selection of an appropriate dissolution medium is a
fundamental stage of the dissolution test.
 Selection of proper medium for dissolution testing depend upon
largely on physicochemical properties of drug.
 The choice of the medium will depend on the purpose of the
dissolution test for batch to batch quality testing.
 we have to maintain sink condition in in vitro. This is can be
achieved by-
1) Bathing the dissolving solid in fresh solvent from time to time.
2) Increasing the volume of dissolution fluid.
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7. SELECTION OF DISSOLUTION MEDIA
3)Removing the dissolved drug by partitioning it from the aqueous
phase of the dissolution fluid into an organic phase placed either
above or below the fluid, for example, hexane or chloroform.
4)Adding a water miscible solvent such as alcohol to the dissolution
medium.
5)By adding selected adsorbent to remove the dissolved drug.
 For class I and class III drugs use of simple aqueous media such as
SGF without enzyme or SIF is recommended.
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8. SELECTION OF DISSOLUTION MEDIA
 For class II and class III drug use of biorelevant media for
dissolution testing is recommended.
 They are:-
 Simulated Gastric Fluid+Surfactant.
 Milk with 3.5 % fat to stimulate fed condition.
 Fasted-State Simulated Intestinal Fluid is used for poorly soluble
drug.
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9. TYPES OF DISSOLUTION MEDIA
 Simulated Gastric Fluid (SGF)
 Simulated Intestinal Fluid (SIG)
 Water
 Biorelevent Media
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10. TYPES OF DISSOLUTION MEDIA
 Simulated Gastric Fluid:-
 The traditional medium to simulate gastric conditions in the fasted
state has been simulated gastric fluid (SGF) of the USP.
 This medium contains hydrochloric acid and sodium chloride, as
well as pepsin and water, and has a pH of 1.2.
 Although the medium addresses many of the qualities of gastric
juice, there are some aspects that could be optimized.
 Simulated Intestinal Fluid:
 The only parameter that has been changed is the pH of the medium.
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11. TYPES OF DISSOLUTION MEDIA
 SIF is composed of Potassium Dihydrogen Phosphate and
Sodium hydroxide.
 Water :-
 Water is an attractive medium that because of its simplicity has
been widely used for quality control purposes.
 However, the pH of water may vary with its source, and water
has no buffer capacity. Thus, for the latter purpose, a better
alternative, which would be more biorelevant in this context, is a
diluted HCl/NaCl solution or a diluted acetate buffer with a final
pH of around 5.
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12. TYPES OF DISSOLUTION MEDIA
 Biorelevent Media:-
 Biorelevant media are virtually the same as intestinal juices.
They contain key natural surfactants (bile salts, phospholipids)
present in intestinal juices. These are missing from ordinary
dissolution media.
 They are virtually the same as the fluids inside the body, it can
provide a much more accurate picture of how drugs and their
formulations are likely to dissolve in vivo.
 The aims are to highlight potential bioavailability issues and
attempt to achieve IVIVC.
 Biorelevant media include Fasting state and Fed state
simulated Gastro Intestinal fluids.
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13. COMPOSITION OF DISSOLUTION MEDIA
MEDIUM pH COMPOSITION AMOUNT
Simulated Gastric Fluid
Without Enzyme (SGF),USP 26
1.2 NaCl 2.0 g
Conc. HCl 7.0 mL
Deionised water 1000 mL
Simulated Gastric Fluid With
Enzyme (SGF),USP 26
1.2 NaCl
Concentrated HCl
2.0 g
7.0 mL
Pepsin 3.2 g
Deionised Water 1000 mL
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14. COMPOSITION OF DISSOLUTION MEDIA
MEDIUM pH COMPOSITION AMOUNT
Simulated
Intestinal Fluid
Without Enzyme
(SIF ),USP 26
6.8 KH2PO4 68.05 g
NaOH 8.96 g
Deionised Water 1000 mL
Simulated
Intestinal Fluid
With Enzyme
(SIF ),USP 26
6.8 KH2PO4
NaOH
68.05 g
8.96 g
Pancreatin X g
Deionised Water 1000 mL
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15. FACTORS AFFECTING DISSOLUTION MEDIA
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 Dissolved Gases-Air
 Dissolution Media Composition and pH
 Viscosity of dissolution media
 Surfactants
 Temperature of dissolution media
 Maintain Sink and Non-sink condition

16. CONCLUSION
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 Dissolution is dynamic property.
 Maintain sink condition throughout study is important parameter in
dissolution.
 Dissolution testing confirm the product quality.
 Dissolution is used to study the rate of dissolution of given drug.
 Physicochemical properties of drug affect the selection of appropriate
dissolution media.
 Dissolution media is different for the different dosage form.
 Dissolution media play important role in IVIVC and bioavailability
studies.
 So,we can call the dissolution media is heart of “Dissolution Studies.”

17. REFERENCE
 Brahmankar, D.M. and Jaiswal, Sunil B. (2009) “A textbook of
Biopharmaceutics and Pharmacokinetics”, 2nd Edition, Delhi,
Vallabh Prakashan, Page no.29, 32-33, 329.
 Indian pharmacopoeia, (2014) Published by Indian
pharmacopoeia commission Ghaziabad, volume-1, page no-760.
 Remington, (1995), “The Science And Practice of Pharmacy”,
volume-1, 19th Edition, Mack publishing Company, Page no.680-
681.
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18. REFERENCE
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 Mr. Ripal Mistry (1971) Selection Of Dissolution Media,
Available From www.Pharmatutor.org
 Bankar V. Umesh, “Pharmaceutical Dissolution Testing”,
Informa Healthcare, New York, London, Page no.174-176.

19. THANK YOU
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