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Drug excipients excipients interaction ppt
1. Matoshri College of Pharmacy
Drug excipientinteraction
hackertyper@du
iker101.net
Presented by –Mr. Rahul Arote
M . pharm 1st year
(pharmaceutics)
2. CONTENT
1. Introduction
2. Drug excipient interaction
3. Importance of this study
4. Mechanism of drug excipient interaction
5. Analytical techniques used to drug detect interaction
3. Introduction
Pharmaceutical
excipient
An excipient is a
pharmacologically
inactive substance
formulated alongside
the API of a medicine to
impart specific qualities
to them.
Role of
excipient
Provide bulk to the
formulation
Protect, support or enhance
the stability of formulation.
Improve bioavailability
of drug
4. Drug excipient interaction
Drug substances are usually in intimate contact
with excipient. Although these are
pharmacologically inert, they can undergo
chemical and physical interaction with drug
substance under favorable condition. These
interactions can lead to instability resulting in the
formulation of new entities.
5. IMPORTANCE OF THESE STUDIES
To find out how compatible an excipient is with API
Maximizes the stability of a dosage form.
Do not have impact on stability of API
Determine the list of excipient that can be used in final dosage form.
Helps to avoid surprise problem during formulation process
These studies are the part of preformulation study and this study data is
essential for IND submission.
6. MECHANISM OF DRUG EXCIPIENT INTERACTION
They can be classified as -
Physical interaction
Chemical interaction
Biopharmaceutical interaction
7. PHYSICAL INTERACTION
These are very common in dosage form and also difficult to detect. These involve
change in-
Dosage uniformity, color, odor, dissolution, stability or
sedimentation rate etc.
These interactions can either be beneficial or detrimental to the
product performance.
Eg. of some these interactions are as follows -
8. Interaction Beneficial effect example Detrimental effect example
1.Complexation cyclodextrin • Tetracycline
• Formulation of
chlorpromazine with tween
80 and sls
2.Adsorption Formulation of indomethacin
(NSAID)USING Kaolin as
adsorbent
Formulation of cetyl
pyridinium chloride tablets
using magnesium stearate as a
lubricant
3.Solid dispersion Formulation of piroxicam
,norfloxacin ,nifedipine and
ibuprofen using PEG of different
grades
Interaction between povidone
and steric acid in a capsule
11. premature breakdon of enteric coat -
Enteric coating polymers e.g. cellulose acetate pathalate
and hydroxyl propyl cellulose acetate pathalate
dissolved prematurly in the stomach in the presence of
anaacids or drugs
cause increse in the ph of the stomach
cause premature relase of ApI in the stomach itself ,which
result in degradtion of drug in stomach
12. analytical techniques used to detect deug excipient
drug -excipient interaction
1. Thermal method -
DSC - Differnatial scanning method
DTA- Differntial thermal method
Isothermal micro microscopy
Hot stage microscopy
2. spectroscopic techniques -
Ft IR spectoscopy
Powder x-RAY diffraction
Soliod state nmr
3.Chromatography -
SIC-self interactive chromatography
TLC -Thin layer chromatography and HPTLC
HPLC -High pressure liqiud chromatography
13. Lachman & Lieberman, The Theory and Practice of Industrial
Pharmacy
N. Fathima, Kajal Ahir, Vandana Patel, Lata Manani, Chirag Patel Drug
excipient interaction and its importance in dosage form development,
Journal of applied Pharmaceutical Science 2011
Priyanka Patel, Kajal Ahir, Vandana Patel, Lata Manani, Chirag Patel
Drug-Excipient compatibility studies: First step for dosage form
development, The Pharma Innovation Journal 2015
Bapi Gorain, Hira Choudhury, Manisha Pandey, Thiagarajan
Madheswaran, Prashant Kesharwani and Rakesh K. Tekade Drug-
Excipient Interaction and Incompatibilities 2018
REFERENCES