This document discusses pharmaceutical suspensions. A suspension is a coarse dispersion where an insoluble solid drug is dispersed throughout a liquid medium. Suspensions are formulated when drugs are insoluble, to mask bitter taste, increase stability, or allow controlled drug release. Common types include oral, topical, and injectable suspensions. Key factors in suspension quality include particle size, stability, redispersibility, and uniform dosing. Evaluation methods examine sedimentation, viscosity, zeta potential, particle size distribution, and response to freeze-thaw cycles. Proper formulation involves selection of suspending agents, preservatives, buffers, and packaging in containers allowing for redispersion.
Suspension are biphasic liquids dosage form in which insoluble solid particulate are uniformly distributed in liquid phase which may be stabilized by inclusion of suspending agents.
a suspension is a heterogeneous mixture containing solid particles that are sufficiently large for sedimentation. Usually they must be larger than one micrometer. A suspension is a heterogeneous mixture in which the solute particles do not dissolve but get suspended throughout the bulk of the medium.
Suspension are biphasic liquids dosage form in which insoluble solid particulate are uniformly distributed in liquid phase which may be stabilized by inclusion of suspending agents.
a suspension is a heterogeneous mixture containing solid particles that are sufficiently large for sedimentation. Usually they must be larger than one micrometer. A suspension is a heterogeneous mixture in which the solute particles do not dissolve but get suspended throughout the bulk of the medium.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
This PPT contains enough information about the chapter SUSPENSION in Pharmaceutics, Which includes Definition, Classification, Route of Administration, Preparation Suspending Agents, Evaluation.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Suspension, interfacial properties of suspended particles, settling in suspensions, formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification, microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions, rheological properties of emulsions.
A detailed study on every aspects of parenteral :- introduction, preformulation factors, essential requirements, vehicles and additives, isotonicity, production procedure, facilities, and controls, container and closure selection and finally the quality control evaluation of parenterals.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
This PPT contains enough information about the chapter SUSPENSION in Pharmaceutics, Which includes Definition, Classification, Route of Administration, Preparation Suspending Agents, Evaluation.
Background: The main objective of present research work is to formulate the Carbamazepine Fast Dissoving tablets. Carbamazepine, an
antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by
blocking use-dependent sodium channels. Methods: The Fast Dissoving tablets of Carbamazepine were prepared employing different
concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Sperdisintegrants by Direct Compression technique
using 32
factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1
and X2 respectively whereas, wetting time, Disintegration time, t
50% ,t90%were selected as dependent variables. Results and Discussion:
Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, Invitro
drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations (C1
, C2
). According to SUPAC guidelines the
formulation (F5
) containing combination of 9.375% Crospovidone and 9.375% Croscarmellose, is the most similar formulation (similarity factor
f
2
=82.675, dissimilarity factor f1
= 2.049 & No significant difference, t= 0.041) to marketed product (TEGRETOL-100). Conclusion: The
selected formulation (F5
) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.665).
KEYWORDS: Carbamazepine, 3
2Factorial Design, Crospovidone , croscarmellose Sodium, Wetting Time, Disintegration Time.
Introduction
Need of Nanosuspension
Advantages of Nanosuspension
Disadvantages of Nanosuspension
Method Of Preparation
Formulation Considerations
Characterization of Nanosuspension
Current Marketed Formulations
Pharmaceutical Applications
The term solid dispersion refers to a group of solid products consisting of a hydrophilic matrix and a hydrophobic drug frequently prepared by fusion solvent method. The matrix can be amorphous or crystalline in nature .
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
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3. SUSPENSIONS 3
The internal phase consisting of insoluble solid particles
having a range of size (0.5 to 5 microns).
The external phase (suspending medium) is generally
aqueous in some instance, but may be an organic or oily
liquid for non oral use.
4. SUSPENSIONS 4
The reasons for the formulation of a Pharmaceutical
suspension:
• When the drug is insoluble.
• To mask the bitter taste of the drug.
• To increase drug stability.
• To achieve controlled/sustained drug release.
6. SUSPENSIONS
6
Based On General Classes
Oral suspension
eg: Paracetamol suspension,
antacid suspensions.
Externally applied suspension
eg :Calamine lotion.
Parenteral suspension
eg: Procaine penicillin G
Insulin Zinc Suspension
Classification
7. SUSPENSIONS 7
Based on Proportion of Solid Particles
Dilute suspension (2 to10%w/v solid)
Eg: cortisone acetate suspension
Concentrated suspension (50%w/v solid)
Eg: zinc oxide suspension
8. Based on Electrokinetic Nature of Solid Particles
Flocculated suspension
Deflocculated suspension
SUSPENSIONS 8
9. SUSPENSIONS 9
Based on Size of Solid Particles
Colloidal suspensions ( < 1 micron)
Coarse suspensions (> 1 micron)
Nano suspensions ( < 50nm)
10. Drug in suspension exhibits higher rate of bioavailability than solid
dosage forms.
Solution > Suspension > Capsule > Compressed Tablet > Coated tablet
Suspension can improve chemical stability of certain drug.
Controlled drug release
Suspension can mask the unpleasant/ bitter taste of drug.
Ease of administration.
Advantages
SUSPENSIONS 10
11. Physical stability , sedimentation and compaction can causes
problems.
It is bulky, sufficient care must be taken during handling and
transport.
It is difficult to formulate.
Uniform and accurate dose can not be achieved unless
suspension are packed in unit dosage form.
Disadvantages
SUSPENSIONS 11
12. SUSPENSIONS 12
The suspended particles should not settle rapidly and sediment
produced, must be easily re-suspended by the use of moderate
amount of shaking.
It should be easy to pour yet not watery and no grittiness.
It should have pleasing odor, colur and palatability.
Good syringeability.
It should be physically,chemically and microbiologically stable.
Parenteral /Ophthalmic suspension should be sterilizable.
Features Desired In Pharmaceutical Suspensions
15. SUSPENSIONS 15
Manufacturing of Suspension:
Suspension can be made by using two methods,
namely:
1. Dispersion methods
2. Precipitation method, this method is divided
again into three kinds :
precipitation with organic solvents
precipitation with a pH change of media
precipitation with double decomposition
16. SUSPENSIONS 16
Precipitated method
1. Organic solvent precipitation :
E.g Prednisolone is precipitated from a methanolic solution to
produce a suspension in water.
2. Precipitation effected by changing the pH of the medium:
E.g Estradiol is readily soluble in potassium or sodium
hydroxidesolutions. If a concentrated solution of estradiol is
thus prepared and added to a weakly acidic solution of
hydrochloric, citric or acetic acids, the estradiol
is precipitaed.
3. Double decomposition method :
E.g: White ointment by dissolving
sulphurated potash.
zinc sulphate soln. in
17. SUSPENSIONS 17
Introduction
Pharmaceutical suspensions for oral use are generally packed
in wide mouth container having adequate space above the
liquid to ensure proper mixing.
Parenteral suspensions are packed in either glass ampoules or
vials.
Packaging of Suspensions
19. SUSPENSIONS 19
Sedimentation method :
Two parameters are studied for determination of sedimentation.
1. Sedimentation volume,
2. Degree of flocculation.
20. Sedimentation volume
Sedimentation volume is calculated according to the equation:
Where,
F = sedimentation volume,
Vu = ultimate height of sediment, and
V
o= initial height of total suspension
F = Vu/Vo
SUSPENSIONS 20
21. SUSPENSIONS 21
Rheological method
It provide information about Settling behaviour .
The arrangement of the vehicle and the particle structural
features.
Brookfield viscometer is used to study the viscosity of the
suspension .
It is mounted on heli path stand and using T-bar spindle.
22. The dial reading is plotted against the number of turns of the
spindle.
The better suspension show a lesser rate of increase of dial
reading with spindle turns, i.e. the curve is horizontal for long
period.
SUSPENSIONS 22
23. Electro kinetic method
Measurement of Zeta-potential using Micro electrophoresis
apparatus & ZetaPlus (Brookhaven Instruments Corporation, USA
It shows the stability of a disperse system.
Micro-Electrophoresis
Apparatus Mk I
ZetaPlus
SUSPENSIONS 23
24. SUSPENSIONS 24
Micromeritic method :
The stability of suspension depends on the particle size of the
dispersed phase.
Change in the particle size with reference to time will provide
useful information regarding the stability of a suspension.
Achange in particle size distribution and crystal habit studied by
microscopy
coulter counter method
25. FREEZE- THAW TEST
Freeze-thaw testing freezer
SUSPENSIONS 25
Freeze-Thaw test conducted by placing the sample in a freezer
for 18 hours followed by thawing at room temperature for 4 to
6 hours.
Repeat the Freeze-Thaw cycle for up to 10 times.
This test is conducted to determine the tendency to crystallize
or cloud)
INNER CHAMBER
26. pH MEASUREMENT
The measurement and maintenance pH is also very important
step in the Quality control testing .
SUSPENSIONS 26
27. Subramanyam C.V.S., Text Book of Physical Pharamaceutics,
PageNo. 374-387.
Aulton M.E 2nd edition, Pharmaceutics-
The Science of Dosage Form Design, Page No. 298-307.
Martin A. Fourth edition, Physical Pharmacy, Page No. 479-481.
Remington, Twentieth edition, The Science and Practice of
Pharmacy ,
Page No. 298-307.
REFERENCES
SUSPENSIONS 27