An excipient is a natural or synthetic substance formulated alongside the active ingredient of a medication to perform various functions. Excipients are included in drug formulations for purposes such as bulking them up, facilitating drug absorption, or conferring other therapeutic effects. Common excipients include binders, coatings, colors, disintegrants, flavors, glidants, lubricants, preservatives, sorbents, sweeteners, and vehicles. Excipients help in manufacturing by aiding in powder flowability, tablet formation, shelf stability, and other processes. The selection of appropriate excipients depends on factors like the route of administration, dosage form, active ingredient, and intended performance of the final drug product
An excipient is a pharmacologically inactive/ inert substance formulated alongside the active pharmaceutical ingredient of a medication. Drug products contain both drug substance (commonly referred to as active pharmaceutical ingredient or API) and excipients.
An excipient is a pharmacologically inactive/ inert substance formulated alongside the active pharmaceutical ingredient of a medication. Drug products contain both drug substance (commonly referred to as active pharmaceutical ingredient or API) and excipients.
Excipients have been defined in many ways, including as inert substances used as vehicles and diluents for drugs. The problem with this definition is that in recent years excipients have proved to be anything but inert, not only possessing the ability to react with other ingredients in the formulation, but also to cause adverse and hypersensitivity reactions in patients. These range from a mild rash to a potentially life-threatening reaction. Different brands of the same drug may contain different excipients, especially preservatives and colourants. The Consumer Medicines Information provides a list of excipients, and information on the safety of individual excipients can be found in drug reference guides.
Pharmaceutical excipients are pharmacologically inert substances which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form to alter the functions.
These are the substances which are added in the formulation along the therapeutic agent so as to impart specific qualities in the formulation.
These are have very little or no therapeutic value but are necessary in the manufacture of various dosage forms.
Purposes served by Additives:
Provide bulk to the formulation.
Facilitate drug absorption or solubility and other pharmacokinetic considerations.
Aid in handling of “API” during manufacturing .
Provide stability and prevent from denaturation etc
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the tablets and its excipients and Ideal properties of tablet and the methods and equipment for there for manufacturing.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Excipients have been defined in many ways, including as inert substances used as vehicles and diluents for drugs. The problem with this definition is that in recent years excipients have proved to be anything but inert, not only possessing the ability to react with other ingredients in the formulation, but also to cause adverse and hypersensitivity reactions in patients. These range from a mild rash to a potentially life-threatening reaction. Different brands of the same drug may contain different excipients, especially preservatives and colourants. The Consumer Medicines Information provides a list of excipients, and information on the safety of individual excipients can be found in drug reference guides.
Pharmaceutical excipients are pharmacologically inert substances which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form to alter the functions.
These are the substances which are added in the formulation along the therapeutic agent so as to impart specific qualities in the formulation.
These are have very little or no therapeutic value but are necessary in the manufacture of various dosage forms.
Purposes served by Additives:
Provide bulk to the formulation.
Facilitate drug absorption or solubility and other pharmacokinetic considerations.
Aid in handling of “API” during manufacturing .
Provide stability and prevent from denaturation etc
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the tablets and its excipients and Ideal properties of tablet and the methods and equipment for there for manufacturing.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
The most common tablet manufacturing process techniques are wet granulation, dry granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide range of common tablet defects that can occur that affect quality.
There are several goals to aim for during the tablet manufacturing process:
Develop tablets that are strong and hard enough to hold up against mechanical shock during manufacturing, packaging, shipping, and dispensing
Formulate tablets that are uniform in weight and drug content
Manufacture bioavailable products according to indication requirements
Create chemically and physically stable tablets that last over long periods
Formulate products that are free of defects and have an elegant finish
Review on Novel Drug Delivery System and Antihypertensive Tabletsijtsrd
Novel drug delivery system offers excellent opportunity to the inventors for developing new technologies for drug administration, dispersible tablets are come under this category as it offers various advantages over conventional tablets. Dispersible tablets offer rapid disintegration in the mouth while came in contact with saliva. It is good find and rapid solution for the problem of dysphasia among geriatrics, as they feel some problem in swallowing a tablet. This article discuss about dispersible tablets, dysphasia, advantages and disadvantages of dispersible tablets. It also discuss about hypertension and antihypertensive tablets. Shivam Pandey | Dr. Hariom Sharma | Jaya Singh ""Review on Novel Drug Delivery System and Antihypertensive Tablets"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd25120.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmacogenomics/25120/review-on-novel-drug-delivery-system-and-antihypertensive-tablets/shivam-pandey
Liquid dosage form Power Presentation ( Sem-I)SumedhGhodke
Liquid dosage divided in mainly two types
1) Monophasic
2) Biphasic
The monophasic liquid dosage form divided into two types
1) Internal
2) External
Biphasic liquid dosage form divided into two parts
1) Suspension
2) Emulsion
1. Excipient
From Wikipedia, the free encyclopedia
This article needs additional citations for verification. Please
help improve this article by adding citations to reliable sources. Unsourced
material may be challenged and removed. (January 2009)
An excipient is a natural or synthetic substance formulated alongside the active ingredient of
a medication,[1]:1
included for the purpose of bulking-up formulations that contain potent active
ingredients (thus often referred to as "bulking agents," "fillers," or "diluents"), or to confer a
therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug
absorption or solubility.[2]
Excipients can also be useful in the manufacturing process, to aid in the
handling of the active substance concerned such as by facilitating powder flowability or non-stick
properties, in addition to aiding in vitro stability such as prevention of denaturation over the expected
shelf life. The selection of appropriate excipients also depends upon the route of administration and
the dosage form, as well as the active ingredient and other factors. Though excipients were at one
time considered to be "inactive" ingredients, they are now understood to be "a key determinant of
dosage form performance".[1]:1
Pharmaceutical regulations and standards require that all ingredients in drugs, as well as
their chemical decomposition products, be identified and shown to be safe. Often, more excipient is
found in a final drug formulation than active ingredient, and practically all marketed drugs contain
excipients.[1]:1
As with new drug substances and dosage formsthereof, novel excipients themselves
can be patented; sometimes, however, a particular formulation involving them is kept as a trade
secret instead (if not easily reverse-engineered).
Contents
[hide]
1 Types
o 1.1 Antiadherents
o 1.2 Binders
o 1.3 Coatings
o 1.4 Colours
o 1.5 Disintegrants
o 1.6 Flavours
o 1.7 Glidants
o 1.8 Lubricants
o 1.9 Preservatives
o 1.10 Sorbents
o 1.11 Sweeteners
o 1.12 Vehicles
2 See also
3 External Link
2. 4 References
Types[edit]
Antiadherents[edit]
Antiadherents reduce the adhesion between the powder (granules) and the punch faces and thus
prevent sticking to tablet punches by offering a non-stick surface. They are also used to help protect
tablets from sticking. The most commonly used is magnesium stearate.
Binders[edit]
Binders hold the ingredients in a tablet together. Binders ensure that tablets and granules can be
formed with required mechanical strength, and give volume to low active dose tablets. Binders are
usually:
Saccharides and their derivatives:
Disaccharides: sucrose, lactose;
Polysaccharides and their derivatives: starches, cellulose or modified cellulose such
as microcrystalline cellulose and cellulose ethers such as hydroxypropyl cellulose(HPC);
Sugar alcohols such as xylitol, sorbitol or maltitol;
Protein: gelatin;
Synthetic polymers: polyvinylpyrrolidone (PVP), polyethylene glycol (PEG)...
Binders are classified according to their application:
Solution binders are dissolved in a solvent (for example water or alcohol can be used in wet
granulation processes). Examples include gelatin, cellulose, cellulose derivatives,
polyvinylpyrrolidone, starch, sucrose and polyethylene glycol.
Dry binders are added to the powder blend, either after a wet granulation step, or as part of a
direct powder compression (DC) formula. Examples include cellulose, methyl cellulose,
polyvinylpyrrolidone and polyethylene glycol.
Coatings[edit]
Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or
unpleasant-tasting tablets easier to swallow. For most coated tablets, a cellulose
ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of sugar and
potential allergens. Occasionally, other coating materials are used, for example synthetic
polymers, shellac, corn protein zein or other polysaccharides. Capsules are coated with gelatin.
Enterics control the rate of drug release and determine where the drug will be released in the
digestive tract. Materials used for enteric coatings include fatty acids, waxes, shellac, plastics, and
plant fibers.
Colours[edit]
Colours are added to improve the appearance of a formulation. Colour consistency is important as it
allows easy identification of a medication. Furthermore, colors often improve the aesthetic look and
3. feel of medications, commonly titanium oxide is used as a coloring agent to produce the popular
opaque colours along with azo dyes for other colors. By increasing these organoleptic properties a
patient is more likely to adhere to their schedule and therapeutic objectives will also have a better
outcome for the patient especially children.
Disintegrants[edit]
Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive tract,
releasing the active ingredients for absorption.
They ensure that when the tablet is in contact with water, it rapidly breaks down into smaller
fragments, facilitating dissolution.
Examples of disintegrants include:
Crosslinked polymers: crosslinked polyvinylpyrrolidone (crospovidone), crosslinked
sodium carboxymethyl cellulose (croscarmellose sodium).
The modified starch sodium starch glycolate.
Flavours[edit]
Flavours can be used to mask unpleasant tasting active ingredients and improve the acceptance
that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit extract)
or artificial.[3]
For example, to improve:[3]
a bitter product - mint, cherry or anise may be used
a salty product - peach, apricot or liquorice may be used
a sour product - raspberry or liquorice may be used
an excessively sweet product - vanilla may be used
Glidants[edit]
Glidants are used to promote powder flow by reducing interparticle friction and cohesion. These are
used in combination with lubricants as they have no ability to reduce die wall friction. Examples
include fumed silica, talc, and magnesium carbonate.
Lubricants[edit]
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or
capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with
low friction between the solid and die wall.
Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic
acid are the most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are
agents added in small quantities to tablet and capsule formulations to improve certain processing
characteristics.
There are three roles identified with lubricants as follows:
True lubricant role:
4. To decrease friction at the interface between a tablet’s surface and the die wall during
ejection and reduce wear on punches & dies.
Anti-adherent role:
Prevent sticking to punch faces or in the case of encapsulation, lubricants
Prevent sticking to machine dosators, tamping pins, etc.
Glidant role:
Enhance product flow by reducing interparticulate friction.
There are two major types of lubricants:
Hydrophilic
Generally poor lubricants, no glidant or anti-adherent properties.
Hydrophobic
Most widely used lubricants in use today are of the hydrophobic category. Hydrophobic
lubricants are generally good lubricants and are usually effective at relatively low
concentrations. Many also have both anti- adherent and glidant properties. For these
reasons, hydrophobic lubricants are used much more frequently than hydrophilic
compounds. Examples include magnesium stearate.
Preservatives[edit]
Some typical preservatives used in pharmaceutical formulations are
Antioxidants like vitamin A, vitamin E, vitamin C, retinyl palmitate,
and selenium
The amino acids cysteine and methionine
Citric acid and sodium citrate[disambiguation needed]
Synthetic preservatives like the parabens: methyl paraben and propyl
paraben.
Sorbents[edit]
Sorbents are used for tablet/capsule moisture-proofing by limited fluid
sorbing (taking up of a liquid or a gas either by adsorption or by absorption)
in a dry state. For example,desiccants absorb water, drying out
(desiccating) the surrounding materials.
Sweeteners[edit]
Sweeteners are added to make the ingredients more palatable, especially
in chewable tablets such as antacid or liquids like cough syrup. Sugar can
be used to mask unpleasant tastes or smells.
5. Vehicles[edit]
In liquid and gel formulations, the bulk excipient that serves as a medium
for conveying the active ingredient is usually called
the vehicle. Petrolatum and mineral oil are common vehicles. In both basic
research and clinical trials, a vehicle can be used as a control to verify the
safety and efficacy of the active ingredient with high confidence. Thus a
vehicle-controlled study can make an especially useful placebo-controlled
study, because the amount of confounding is as small as possible.
See also[edit]
Pharmaceutics
Active ingredient
Pharmacology - Placebo - Placebo effect - Quality system
External Link[edit]
FDA database for Inactive Ingredient Search for Approved Drug
Products
Excipient selection for injectable / parenteral formulations
References[edit]
1. ^ Jump up to:a b c Bhattacharyya, Lokesh; Schuber, Stefan; Sheehan,
Catherine; William, Roger (2006). "Excipients: Background/Introduction".
In Katdare, Ashok; Chaubal, Mahesh.Excipient Development for
Pharmaceutical, Biotechnology, and Drug Delivery Systems.CRC
Press. ISBN 9781420004137. OCLC 476062541.
2. Jump up^ Lesney, Mark S. (January 2001). "More than just the sugar in
the pill". Today's Chemist at Work 10 (1): 30–6. ISSN 1532-4494.
Retrieved August 13, 2013.
3. ^ Jump up to:a b Mills, Simon (April 2007). Excipients (MICROSOFT
POWERPOINT). Training