..Preformulation introduction and organoleptic properties.pptx..

1. PREFORMULATION
STUDIES
PRESENTED TO PRESENTED BY
DR.SHAILESH.T SHREYA UG
DEPARTMENT OF PHARMACEUTICS M PHARM 1ST YEAR
JSS COLLEGE OF PHARMACY –MYSURU QUALITY ASSURANCE

2. 1.Introduction
2.Defination
3.Objective and concepts of preformulation
4.Preformulation parameters
5.Benefits
5.Organoleptic properties
6.References
CONTENTS

3. Prior to the development of any dosage form , it is
essential that the physical chemical and fundamental
properties of the drug molecule must be investigated.
Preformulation is the first step in the rational
development of a drug substance.
It’s a branch of pharmaceutical sciences that utilizes
biopharmaceutical principles to find the
pharmaceutical properties of the drug molecule.
INTRODUCTION

4. Investigation of physciochemical properties of a new
drug compond that could affect drug performance
and development of an efficious dosage form.
It is the phase of reasearch and development
characterized physical and chemical properties of a
drug molecule in order to develop safe effective and
stable dosage form.
DEFINITION

5. The preformulation investigations confirm that there
are no significant barriers to the compound’s
development as a marketed drug.
To establish the necessary physicochemical parameters
of a new drug substance
To establish compatibility of drug with excipients
The formulation scientist uses these informations to
develop dosage forms
OBJECTIVES AND CONCEPTS
OF PREFORMULATION

6. Bulk characteristic
1. Organoleptic properties
2. Particle size & surface area
3. Crystallinity & polymorphism
Solubility Analysis
1. Aqueous solobility
2. Dissolution
Stability analysis
1. Solid state and solution state
stability
1. Oxidation
2. Hydrolysis
3. Photolysis
4. polymerization
Physial characteristic Chemical characteristic
PREFORMULATION
PARAMETERS

7. Gives direction for development of formulation in
choice of dosage form , excipents, compostion,
physical compatibility
Helps in adjustment of pharmacokinetic
biopharmaceutical properties
Support for process development of drug substance
Support for development of PAT(Process Analytical
Technology)
BENEFITS

8. Color Odour Taste
Off -white Pungent Acidic
Cream - Yellow Sulfurous Bitter
Shiny Fruity Sweet
Tan Aromatic Tasteless
Odourless Bland
Intense
 Organoleptic properties are the aspects that can be
experienced through one’s senses like taste, smell, sight, touch.
 The color, odour and taste of the new drug must be recorded
using descriptive terminology.
ORGANOLEPTIC PROPERTIES

9.  color is generally a function
of drug’s inherent chemical
structure relating to a
certain level of
unsaturation.
 Color intensity relates to
extend of conjugated
unsaturation as well as the
presence of chromophores.
 The substance may exhibit an
inherent odor characteristic of
major functional group
present.
 Taste is considered as
unpalatable, consideration is
given to the use of a less
soluble chemical form of the
drug
 Both of these can be
suppressed by using
appropriate flavours and
excipients.
Color Odour &Taste
ORGANOLEPTIC PROPERTIES

10.  Leon Lachman , Lieberman H A and Joseph L K: The Theory and Practice
of Industrial Pharmacy. Varghese publishing house, Bombay.
 Vilegave, K., Vidyasagar, G. and Chandankar, P., 2013. Preformulation
studies of pharmaceutical new drug molecule and products: An
Overview. The American Journal of Pharmacy.
 Verma, G. and Mishra, M.K., 2016. Pharmaceutical preformulation studies
in formulation and development of new dosage form: A review. Int. J.
Pharma Res. Rev, 5(10).
 Jain NK and Sharma SN: A Text book of professional pharmacy.
 Brahmankar DM and Jaiswal SB: Absorption of drugs in:.
Biopharmaceutics and Pharmacokinetics A treatise.
REFERENCES

11. THANK YOU