The document discusses liquid oral dosage forms such as syrups and elixirs. It covers formulation and manufacturing considerations for liquid orals including solubility enhancement techniques, preservation, viscosity control, sweetening agents, flavors, and stability testing. Specific types of oral liquids are described like solutions, suspensions, emulsions. The key steps in formulation of syrups and elixirs involve solubility of drugs, addition of preservatives, viscosity agents, sweeteners and flavors. Manufacturing involves selection of raw materials, equipment used for mixing, filling and packaging.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS.
Physical Factors
Loss of volatile constituents
Loss of water
Absorption of water
Crystal growth
Polymorphism changes
Colour changes
Chemical factors
Hydrolysis
Oxidation
Carboxylation
Decarboxylation
Isomerization
Polymerization
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS.
Physical Factors
Loss of volatile constituents
Loss of water
Absorption of water
Crystal growth
Polymorphism changes
Colour changes
Chemical factors
Hydrolysis
Oxidation
Carboxylation
Decarboxylation
Isomerization
Polymerization
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Introduction
Mechanisms of protein drug binding
Kinetics of protein drug binding
Classes of protein drug binding.
1. Binding of drug to blood components.
(a) Plasma proteins
(b) Blood cells
2. Binding of drug to extravascular tissue protein
Determination of Protein-drug Binding
Factors affecting protein drug binding
Significance of protein/tissue binding of drug
A comprehensive interpretation of pellets based on their definitions, advantages, disadvantages, mechanism of pellet formation and growth, pelletization techniques, formulation requirements, and the equipment system for manufacture of pellets.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Liquid oral topic in Industrial Pharmacy contains many topics like solution, elixirs, syrups, emulsion, and suspension. This topic includes general introduction, types, formulation, components, uses, and Quality control tests. These are also beneficial in other subjects like Pharmaceutics.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Introduction
Mechanisms of protein drug binding
Kinetics of protein drug binding
Classes of protein drug binding.
1. Binding of drug to blood components.
(a) Plasma proteins
(b) Blood cells
2. Binding of drug to extravascular tissue protein
Determination of Protein-drug Binding
Factors affecting protein drug binding
Significance of protein/tissue binding of drug
A comprehensive interpretation of pellets based on their definitions, advantages, disadvantages, mechanism of pellet formation and growth, pelletization techniques, formulation requirements, and the equipment system for manufacture of pellets.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
The presentation provides a concise information regarding various methods or techniques for enhancing solubility of different drugs and will prove useful to students & researchers.
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
1. UNIT II
LIQUID ORALS
• Formulation and manufacturing consideration of
syrups and elixirs
suspensions and emulsions
• Filling and packaging
• Evaluation of liquid orals official in
pharmacopoeia
2. Definition: Liquid dosage form defined as the active
ingredients are dissolved or suspended in aqueous or non
aqueous solvent (or) incorporating the drug into one of the
two phases of an oil and water system.
Advantages
• Immediately available for absorption
• Easy administration
• Easy to color, flavor, sweeten
• Easy to change the dose
Disadvantages
• Bulky than tablets or capsule, so difficult to carry.
• Less stable & Less accuracy in dose.
• Better Incompatibility than solid dosage form.
• Accident breakage of container
3.
4. ORAL LIQUID SOLUTIONS
Defn: It is a homogenous formulation contains one phase in
which the Drug and excipients used are dissolved in the given
solvent to form clear solutions
• Formulation of solutions have many technical problems to
the industrial pharmacist
• Some drugs are very unstable in solution form
• Special techniques are adopted for poorly soluble drugs
• Final formulation should be pharmaceutically elegant
with regard to tast, appearance and viscosity
• So, it is important to consider the factors influencing the
formulations and manufacture of Pharmaceutical oral
solutions.
5. FORMULATION AND MANUFACTURING CONSIDERATION
OF LIQUID ORAL SOLUTIONS (Syrups and Elixirs)
Formulation consideration:
1. Solubility
•pH
•Cosolvency
•Dielectric constant
•Solubilization
•Complexation
•Hydrotrophy
•Chemical modification of
the drug
2. Preservation, Viscosity
control, Sweetening Agents,
Flavors, Appearance
3. Stability
Manufacturing consideration:
1. Raw material
2. Equipment
3. Compounding procedure
4. Packaging
6. FORMULATION CONSIDERATIONS
1. Solubility:
• Substance (whether it is drug or excipient) should dissolve
in given system
• It depends on the nature and intensity of forces present in
solute and the solvent and their interation
• For that the equibilirium solubility is to be determined. The
excess amount of finely powdered drug is placed in vial
along with solvent and agitated with constant temperature
(usually 30°C or room temp).
• The amount of drug dissolved in solvent is determined
periodically by assay of filtered solution
• The study to be conducted at various temperature
condition for designing the formulation.
• Solubility can be increased by considering the following
factors,
7. • pH
• Drugs are usually a weak acids or weak bases
• Solubility of their drug is affected by pH of their
environment
• The Solution of acidic drugs is equal to the solubility of
undissociated acid in moles per liter.
DH (Solid) + Solvent → DH(Solution) + D- + H+
• The pH of a solution is a measure of the molar
concentration of hydrogen ions in the solution and as such
is a measure of the acidity or basicity of the solution
• The pH of the solution or the buffer selection should
satisfies the stability and physiological compatibility.
• For many drugs, pH adjustment doesnot provide the
effective formulation and will affect the stability of the
formulation (Sugars and Flavors)
• This is overcome by using cosolvency, solubilization,
complex phenomena or chemical modification of the drug
8. • Co Solvency:
• Weak electrolytes and non polar molecules have poor
water solubility
• It is increased by addition of water miscible solvent in
which the drug has good solubility. This process is known as
Cosolvency
• The solvents used in combination to increase the solubility
of the solute is known as Cosolvents
• Co solvent system mechanism: It reduce the interfacial
tension bet. aq solvents and the hydrophobic solute
• Another theory is that the cosolvents surrounds and adsorb
the solute and hence it reduce the interfacial tension of
hydrophobic surface and water
• Eg of cosolvents: Ethanol, Sorbitol, Glycerin, Propylene
glycol, PVP, Ethyl lactate, 1,3 butylene glycol.
9. • Dielectric Constant:
• Dielectric constant of the solvent used for dissolving the solute is
important for considering the solubility, Stability and organoleptic
characterics of the formulation
• Every solute shows maximum solubility at some specific dielectric
constant of the given solvent system
• Solubilization:
• It is defined as the spontaneous passage of poorly water soluble
solute molecules into an aqueous solution of surfactant, in which
it is thermodynamically stable.
• The property of Surfactant to form colloidal aggregates known as
micelles and the concentration of surfactant at which the micelles
are formed is known as Critical micellar concentration
• The drug gets entrapped into the miscelles and thus it reduces
interfacial tension bet hydrophobic surface and water and the
solubility gets increased
• HLB value of surfactants is higher than, they are best solubilizing
agent Eg: Tween (Polysorbates), Lanolin esters and ethers, Sucrose
monoesters
10. • Complexation:
• Organic compounds in solution are generally tend to
associate with each other
• Complexation of solute with complexing agent will increase
the solubility.
• The selection of complexing agent is important and it is
done by considering the safety, stability and therapeutic
efficacy of the drug product
• Also the interaction of complexing agent with other
excipients also considered Eg: Tween 80 will form complex
with parabens and inactive its preservative property
11. • Hydrotrophy:
• It means the increasing the solubility of drug in water by
addition of large amount of some additives.
• This phenomenon is closely related to complexing agent
• Eg: Large conc of sodium benzoate(Preservative) will
increase the solubility of caffeine
• Chemical modification of the drug
• Many poorly soluble drugs can be chemically modified to
water soluble derivatives.
• EG: Disodium phosphate salt of betamethasone is more
soluble than Betamethasone
• But it has limitation. It is considered as new drug and it is
evaluated for its pharmacological activity, toxicity and
pharmaceutical evaluation
12. 2. Preservation
• Preservatives are added to the oral liquid formulation to prevent
the microbial contamination
• Microbial growth in formulation will lead to health hazard to the
user and also affect the product stability
• Single preservative cannot achieve the broad spectrum of killing
microorganism and so it is used in formulation as combinations
• Four groups of Preservatives:
• Acidic Eg: Phenol, Cl- Cresol, Benzoic acid and its esters, Alkyl
esters of parahydroxy benzoic acid
• Neutral Eg: Chlorobutanol, Benzyl alcohol
• Mercurial Eg: Thiomersal, Phenyl mercuric nitrate and acetate
• Quartenary ammonium compounds Eg: Benzalkonium chloride,
Cetylpyridinium chloride
• Syrups containing 85% sugar, propylene glycol, glycerin may resist
bacterial growth as it exert high osmotic pressure on
microorganisms.
• Common organism seen in oral liquids are Salmonella, E.coli,
Pseudomonas, Enterobacter species, Clostridium and candida
albicans
13. 3. Sweetening agents:
• These are the major portion of the oral liquids to provide
the pleasant taste to the formulation
• Sucrose is the main and major excipient
• It is frequently used in combination with sorbitol, glycern
and other polyols which reduce crystallization of sucrose
• Crystallizaton of sucrose will create the Caplocking problem
• Other than Sucrose, liquid glucose is used as sweetening
agent but it is difficult to handle since its viscosity is very
high and gummy nature
• To impart additonal sweet to the formulation of bitter
drugs, Saccharine, Aspartame, Neotame, Sucralose are
added as artificial sweeter. These are many times more
sweeter than sucrose.
14. 4. Viscosity Control
• Viscosity of the formulation is increased to improve the
platability and pourability of the liquids
• This is achieved by increasing sugar concentration, or by
incorporating viscosity enhancers like PVP, Methylcellulose,
HPMC, HPC, Sod.CMC
5. Flavouring agent:
• These agents are added in the formulation to mask the
taste sensations effectively
• Menthol, Chloroform and various salts are flavor adjuncts
• It produces their own flavour and odour and give mild
anaesthetic effect to the taste buds. By this the bitter and
unpleasant taste and odour are not observed by taste buds
15.
16. 6. Appearance:
• Overall appearance of the liquid products depends
primarily on their color and clarity
• The color and dye used in formulation should be approved
by FD&C
• Clarity is achieved by Clarification and Filtration of the
formulated liquid product. Eg: Centrifugation, Decantation,
Filtration etc
7. Stability
• Chemical Stability:
• It is low risk in homogeneous system than heterogeneous
system.
• Techniques for prediction the chemical stability are well
defined
17. • Physical Stability:
• It means the formulation should retains the viscosity,
color, clarity, taste and odor throughout its shelf life
• Color are measured by spectrophotometrically
• Clarity is determined by allowing focussed beam of light
through the solution - Undissolved particles scatter the
light
• Taste and odor tested by unbiased taste sensitive
individual
• Flavors and color of the formulation are often changes
with time due to adsorption to containers or closures,
evaporation, concentration of product or chemical
breakdown of the drug
18. • MANUFACTURING CONSIDERATIONS
Raw materals:
• The raw materials used in the formulations should comply
all the specification like identity, purity, uniformity and free
from microorganism
• Water is the main vehicle and it should be a purified water
and meet the USP spec. It is obtained by distillation or ion
exchange treatment or UV sterilization of water or by
filtration
Equipment
• Mixing tanks with agitator
• Measuring device
• Filtration system
• Sterilization aid
• Discharging bins
19. • All equipments are cleaned and sanitized before use
• Tanks are made of Polished Stainless steel made of steam
jacketed or cooling jacket with see through charging ports
and illumination
• After formulation, the liquids are clarified through filtration
and transported to filling area through piping
Compounding procedure:
• The rate at which the oral solution is achieved is influenced
by compounding procedure
• Oral solutions are prepared by charging rapidly dissolving
materials to the solvent and agitated until the solution is
homogeneous.
• When more concentrated solute is added to the solvent,
heat is used to aid dissolving
20. Packaging
• Filling of oral solution is influenced by viscosity, surface tension,
foam production and compatability of materials with packaging
material
• Filling methods - Gravimetric, Volumetric and Constant level
• Gravimetric Filling: Containers are filled with liquid to a given
weight. Limited to Large container or high viscous products.
Cannot be used in high speed and automatic equipments
• Volumetric Filling: It is done by positive displacement piston
action. Each filling station is equipped with measuring piston and
cylinder
• Constant level: It uses the container as the means for controlling
the fill of each unit. Any dimensional variations in the containers
result in variation in the fill
Tecchniques of Filling:
• Vacuum filling
• Gravity Vacuum filling
• Pressure Vacuum filling.
21. SYRUPS
Defn: “Syrups are concentrated aqueous preparations of a sugar or
sugar substitute with or without flavoring agents and medicinal
substances.”
Types of Syrups
Simple syrup
Medicated syrups
Non-medicated syrups
Simple Syrups
A simple syrup contains only sucrose and purified water
Concentration of Syrup:
According to B.P:
67.7% W/W
According to USP:
85% W/V
22. Non Medicated Syrups
• “Syrups containing flavoring agents but not medicinal
substances are called non-medicated or flavored syrups”
• Use:
• These syrups are to serve as pleasant tasting vehicle for
medicinal substances to be added in the preparation of a
standard formula for a medicated syrup.
• Example:
Cocoa syrup
Suspension of cocoa powder in aqueous vehicle sweetened
and thickened with sucrose
Orange syrup
Sucrose-based syrup uses sweet orange peel tincture
Raspberry syrup
Sucrose-based syrup with raspberry juice about 48% by
volume.
23. Medicated Syrups
• Syrups containing therapeutic agent are called medicated
Syrups.
• Eg: Paracetamol syrup - Analgesic and Antipyretic
Sodium Valproate syrup - Anticonvulsant
Components of Syrups:
• Sugar
• Antimicrobial preservatics
• Flavorants
• Colorants
• Special solvents, Thickeners, Solubilizers, Stabilizers etc
24. • Sugar and its derivatives:
• Sugar Eg: Sucrose & Dextrose
• Non Sugar Eg: Sorbitol, Glycerin, Propylene glycol
Functions of sucrose or its derivatives:
i. Viscosity
ii. Sweetness
iii. Flavoring agent
iv. Masking bitter taste.
Most syrups contain a high proportion of sucrose, usually
60% to 80% for desirable sweetness, viscosity and stability.
Sugar is replaced with its derivatives at certain circumstances
like Diabetic
25. • Antimicrobial Preservatives:
• To protect a syrup against microbial growth
• Its concentration varies with proportion of water
• Eg:
• Benzoic acid, Sod. benzoate, Methyl paraben, Propyl
paraben, Alcohol
• Flavoring agents:
• To aid the syrup pleasant taste
• Eg: Natural occuring flavor - Orange oil, Synthetic flavor -
Vanillin
• Colorants:
• To enhance the appearance of syrup Eg: FDC accepted
colors are used
• It should be water soluble and stable in all pH range.
26. • Preparation of Syrups
• With aid of heat
• Agitation without heat
• Addition of Sugar to medicted liquid
• Percolation
• With the aid of heat
• It is made when the components are not damaged or
volatilized by heat
• Sugar is dissolved in water with the aid of heat. With the
hot syrup, the heat stable materials are dissolved in it.
• After dissolving, cool it to obtain for room temperature
• Agitation without the aid of heat:
• Sucrose or other ingredients are dissolved in water with the
help of high speed agitator and without heat
• It is more time consuming but provides maximum stability
27. • Addition of sucrose to medicated liquid
• Used often for tinctures when contain alcohol soluble
substance
• Prepared with alcohol or hydroalcoholic vehicles
• Water Or Alcohol insoluble substance get separated and
filtered
• The filtrates are medicated liquid which is added to Sugar
syrup
• Solution by Extraction:
• Vegetable or animal origin are often extracted with suitable
solvent.
• Eg: Ipecac Syrup - By percolation method
• Powdered Ipecac → Add Glycerin Syrup → Extracted →
Alkaloids, Emetine, Cephaeline and Psycotrine are
extracted from Ipecac Use: As Emetic
28. • Packaging of Syrup:
• Syrup, as a pharmaceutical product requires safe, secure
and tamper-proof handling while packaging.
• Packaging of syrups needs to ensure complete protection
from contamination and microbial growth.
• It should ensure that it provides extended shelf life.
• The general process:
• Filling
• Capping
• Sealing
• Coding & labeling
• Wrapping
29. • Process involved in the syrup packaging
• Empty Bottles are rinsed though Air-jet cleaning
• After complete cleaning, bottles are tested & transferred
ahead for filling
• Filling machines with their automatic piston fills the bottles
with accurate volume of syrup
• Capping is done on bottle through capping machines
• Plastic or aluminum are bound over the neck of the bottle
for secure sealing
• Important details regarding packaging date & expiry date
are printed on bottles
30. • Labelling
• Every pharmaceutical preparation requires a label to be
produced before the product can be dispensed or sold to
patient.
• The accuracy of the label is of very importance as it conveys
essential information to the patient on the use of
preparation
• Storage
• Store in room temperature and in dark place
• Advantage of syrup:
• Beneficial for childrens and old age patients
• Unpleasant taste masking
• Palatable
• Easiest route of administration
31. • Disadvantages of Syrup
• Delayed onset of action because absorption takes time.
• Not suitable in emergency and for unconscious patients.
• Not convenient for a patient with a certain disorders such
as diarrhea, ulceration, and nausea.
• Can’t avoid first pass metabolism
32. • ELIXIRS
• Defn: “Elixirs are clear, sweetened, flavored, hydro-
alcoholic solutions intended for oral use and are usually
flavored to enhance their palatability.”
• Need of Elixir:
• Some drug are insoluble in water so in this case we can’t
use syrups & suspension.
• So we have to make a dosage form which could dissolve
non polar compounds
• Aid in masking the unpleasant taste of the active
ingredients
• Components of Elixirs:
• Water and Alcohol
• Sweetening agents
• Propylene glycol
• Preservatives
• flavorants
33. • Water and Alcohol:
• Each elixir requires a specific blend of alcohol and water to
maintain all of the components in solution.
• Naturally, proportion of requirement of alcohol is greater
for those elixirs having components with poor water
solubility than those elixirs having components with good
water solubility.
• Sweetening Agents
• sucrose or with sucrose syrup,
• Sorbitol, glycerine
• Artificial sweetner
• Elixirs having a high alcoholic content usually contain
artificial sweetner such as saccharine,which is required in
very small amount rather than sucrose
• Propylene glycol
• A colorless viscous liquid used as a solvent in the
preparation of certain medications. It also inhibits the
growth of fungi and microorganisms
34. • Preservatives:
• Methyl Paraben and Propyl Paraben
• Sodium and Potassium benzoates
• Elixirs containing more than 10 to 12 % of alcohol are
usually act as self preserving and donot require additional
antimicrobial agent
• Flavoring agent
• It aids palatable taste to the formulation
• Mask the bitter taste
• Eg: Natural flavor and Synthetic flavors
35. • Preparation of Elixirs
• Elixirs are usually prepared by simple solution with
agitation.
• Alcohol-soluble and water-soluble components are
generally dissolved separately in alcohol and in purified
water, respectively.
• Then the aqueous solution is added to the alcoholic
solution to maintain the highest possible alcoholic strength
at all times so that minimal separation of the alcohol-
soluble components occurs.
• When the two solutions are completely mixed, the mixture
is made to volume with the specified solvent or vehicle.
• Finally filtration is done to obtain clear liquid
• Types of Elixir:
• Non medicated
• Medicated
36. • Non medicated Elixir:
• These are simple elixirs that donot contain medicated
agents
• It is used for addition of a drug into it or dilution to an
existing medicated elixir.
• It only contains Water, alcohol, sweetening agent and
coloring agent
• Eg: Aromatic Elixir, Compound benzaldehyde elixir,
Isoalcoholic elixir
• Medicated Elixir
• Medicated elixirs are a solution of the active ingredient
dissolved in water and an alcohol often along with other
excipients such as preservatives
• Mostly single therapeutic agent is present
• Eg: Antihistaminic Elixir - Diphenhydramine HCl, Analgesic
Elixir - Acetaminophen, Cardiotonic Elixir - Digoxin
37. • Storage:
• Keep below 30°C (at room temperature).
• Container should be tightly closed.
• Keep in light resistant ambered color container;
• Protect from direct sunlight and keep away from ignition
• Advantages of Elixir:
• Self preservative
• Stable
• Easily prepared and administered
• Disadvantage of Elixir
• Less effective than syrup in masking the taste
• Contains alcohol can be harmful to children and adults
• Since it is volatile, air tight screw top container is required
38. • SUSPENSIONS
• Defn:
• These are two phase system contains continuous phase and
dispersed phase. The continuous phase is generally a liquid
and the dispersed phase is made up of particles but
dispersed throughout the continuous phase intended for
physiological absorption.
• Almost all suspension systems separate on standing
• Main consideration in formulation is
• to prevent the separation or
• to decrease the rate of settling and
• to permit easy resuspendability
39. Formulation and Manufacturing considerations:
• Theoretical Considerations:
• Wetting:
• It is defined as that the ability of liquid to contact the
surface of the solid according to its affinity towards it
• There exist a angle of contact between the liquid and the
solid. This contact angle θ results from an equililbrium
formed between three interfacial tensions (Liqud-Vapor,
Liquid-Solid, Solid- Vapor)
• Hydrophobic substances repel water and difficult to
disperse and float on the surface of the liquid due to
interfacial tension
• Wetting agent (Usually surfactant) which reduce the solid-
liquid interfacial tension. It will hold both hydrophobic
substance and water
• Other materials such as Hydrophilic Polymers (Na.CMC),
Water insoluble hydrophilic materials (Bentonite,
Aluminium Magnesium Silicate) aided in dispersion also for
viscosity building
40. • Wettabiity is measured by wet point and flow point
method
• Wet point is the amount of vehicle needed to wet all the
powder
• Flow point is the amount of vehicle needed to produce
pourability
• Low wet point and low flow point indicates the good
dispersion
• Particle interactions and Behaviour
• Presence of large amount of electrolytes will result in
salting out effects due to aggregation of particles
• Increasing the conc. of ions will decrease the thickness of
diffuse double layer and hence aggregation is done
• Aggregation is further termed as Flocculation, Coagulation
41. • Flocculation - It is a fibrous, fluffy open network of
aggregated particles. The structure is quite rigid and hence
these aggregates settles quickly to form high sediment
height but easily redispersible because the particles
contains individual aggregates are apart from one another
to prevent from caking
42. • Coagulation - It is a tight packing produced by surface film
bonding. These aggregates settle down slowly to low
sediment heights. But formed sediment heights is
composed of closed aggregates are not easily redispersed.
43. • The tendency of particles to aggregate depends on the
forces of attraction and repulsion between them
• The attractive forces is due to Vander waals forces.
(Combination of ionic, dipole and induced dipole
interaction)
• Caking is defined as the formation of non redispersible
sediment within a suspension system. It is due to crystal
bridging and coagule formation
• Crystal bridging - particle surface crystal growth occurs on
two or more particles which results in steady formation of
crystal linked particles.
• Ostwald ripening - Small changes in temperature causes
crystal bridging lead to rapid caking during storage of
suspension.
44. • Sedimentation Rates
• According to Stokes equation, the velocity of particle in
suspension is
• Factors influencing the sedimentation rates are particles
charges, aggregation, Zeta potential and aqueous system
used
• Crystal habit:
• It is defined as the outward appearance of an
agglomeration of crystals.
• It is used to study the suspension redispersibility,
sedimentation rate, physical stability and appearance and
also affect the dissolution properties
• Individual particles crystal characteristics are differ from
agglomerate crystal particles
45. • Crystal structure factors:
• Effect of Crystal properties are more produced when the
suspension is made from precipitation techniques than
dispersion technique
• The rate of cooling, degree of agitation and size & number
of nuclei will affect the degree of supersaturation lead to
change in crystal habit.
• Change in crystal characteristics leads to drug
decomposition, salting out, change in pH, change in particle
size distribution and also change in temperature
• Polymorphism is the term used to specify the different
crystal structure formed by same chemical compound
which exhibit different solubilities, melting points and x ray
diffraction patterns
46. Formation of Suspension:
• Precipitation methods:
• Organic solvent precipitation
• Water insoluble drugs can be precipitated by dissolving
them in water miscible organic solvents and then the
organic phase is added to the water Eg: Ethanol, Methanol,
Propylene glycol and Polyethylene glycol
• Different polymeric forms are obtained when the organic
phase is changed Eg: Prednisolone in methanol gives
sesquihydrate form, where in acetone it gives anhydrous
crystal form. Former is easily suspended in water
• Precipitation effected by changing the pH of medium
• It is applicable to drugs in which solubility is dependent on
pH value. Eg: Estradiol suspensions can be prepared by
changing the pH of its aqueous solution. It is readily soluble
in alkali pH.
• Double decomposition is a simple reaction in which the
positive and negative ions in two compounds switch
between them to form new compounds
47. • Dispersion Methods
• Solid phase is dispersed in Continuous phase by wetting of
solid by liquid readily
• This is achieved by use of Surfactants, Suspending agents
such as synthetic polymers, polyelectrolytes, natural gums,
clay etc and particle size reduction
Editor's Notes
law of mass action (the rate of chem. rxn is directly proportional to the concentration of reacting substance)