This document provides an introduction to dosage forms, which are the means by which drug molecules are delivered to sites of action within the body. It discusses the need for dosage forms due to challenges with direct clinical use of active drug substances. The document then classifies and describes various types of solid, liquid, semi-solid, inhaled, and parenteral dosage forms including tablets, capsules, solutions, suspensions, emulsions, ointments, creams, suppositories, injections and more. Excipients are also discussed as inactive ingredients that aid drug delivery without affecting therapeutic action.
it is GTU based syllabus chapter and all the points are covered like... handling of prescription , etc... very helpful for pharmacy students...and its in easy language..
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
it is GTU based syllabus chapter and all the points are covered like... handling of prescription , etc... very helpful for pharmacy students...and its in easy language..
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
Semisolid dosage forms: Definitions, classification, mechanisms and factors influencing dermal penetration of drugs. Preparation of ointments, pastes, creams and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid dosages forms
In ancient India the sources of drugs were of vegetable, animal and mineral origin.(Ayurveda).They were prepared empirically by few experienced persons. Knowledge of that medical system was usually kept secret within a family (Folkore).There were no scientific methods of standardization of drugs.
This presentation quotes various pharmaceutical calculations with examples. The following aspects like percentage calculations, alcoholic dilutions, Alligation method, proof spirit calculations, isotonicity adjustment, posology, temperature measurements, dialysis clearance, Pharmacokinetics calculations were covered with examples.
Semisolid dosage forms: Definitions, classification, mechanisms and factors influencing dermal penetration of drugs. Preparation of ointments, pastes, creams and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid dosages forms
In ancient India the sources of drugs were of vegetable, animal and mineral origin.(Ayurveda).They were prepared empirically by few experienced persons. Knowledge of that medical system was usually kept secret within a family (Folkore).There were no scientific methods of standardization of drugs.
This presentation quotes various pharmaceutical calculations with examples. The following aspects like percentage calculations, alcoholic dilutions, Alligation method, proof spirit calculations, isotonicity adjustment, posology, temperature measurements, dialysis clearance, Pharmacokinetics calculations were covered with examples.
Let's Know About Your Drugs ,,, Part - III ( Dosage Forms and Drug Delivery Systems) for study purpose pharmaceutical professional such as students and other specialized field. Presentation for "LEARN & EARN KNOWLEDGE" based.
Thanks all of you for your support...
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.
‘Targeted drug delivery system is a special form of drug delivery system where the medicament is selectively targeted or delivered only to its site of action or absorption and not to the non-target organs or tissues or cells.’
PHARMACOKINETIC MODELS
Drug movement within the body is a complex process. The major objective is therefore to develop a generalized and simple approach to describe, analyse and interpret the data obtained during in vivo drug disposition studies.
The two major approaches in the quantitative study of various kinetic processes of drug disposition in the body are
Model approach, and
Model-independent approach (also called as non-compartmental analysis).
Biopharmaceutics: Mechanisms of Drug AbsorptionSURYAKANTVERMA2
Biopharmaceutics is defined as the study of factors influencing the rate and amount of drug that reaches the systemic circulation and the use of this information to optimise the therapeutic efficacy of the drug products.
A geographical indication (GI) is a name or sign used on certain products which corresponds to a specific geographical location or origin (e.g. a town, region, or country)
Examples: Basmati rice, Swiss watches etc
Design, optimization and in vitro evaluation of gastroretentive hollow micros...SURYAKANTVERMA2
To modify the GIT time is one of the main challenge in the development of oral controlled drug delivery system.
Gastric emptying of pharmaceutical dosage form is highly variable and dependent on the dosage form and the fed/fasted state of the stomach.
Normal gastric residence time usually ranges between 5 minutes to 2 hours.
Formulation and evaluation of fast dissolving tabletsSURYAKANTVERMA2
The concept of mouth dissolving drug delivery systems (MDDDS) or fast dissolving tablets emerged with an objective to improve patient’s compliance.
These dosage forms rapidly disintegrate and/or dissolve to release the drug as soon as they come in contact with saliva, thus obviating the need for water during administration, an attribute that makes them highly attractive for pediatric and geriatric patients.
Microsoft Windows, or simply Windows, is a metafamily of graphical operating systems developed, marketed, and sold by Microsoft. It consists of several families of operating systems, each of which cater to a certain sector of the computing industry with the OS typically associated with IBM PC compatible architecture. Active Windows families include Windows NT and Windows Embedded; these may encompass subfamilies, e.g. Windows Embedded Compact (Windows CE) or Windows Server. Defunct Windows families include Windows 9x, Windows Mobile and Windows Phone.
The greenhouse effect is a process by which thermal radiation from a planetary surface is absorbed by atmospheric greenhouse gases, and is re-radiated in all directions.
“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product”.
Introduction to environment and environmental studiesSURYAKANTVERMA2
“Environmental studies” is the scientific study of our environment and our place in it.
Definition: “Environmental studies” is the study of environmental issues.
It has broader coverage than environmental science and includes social aspects of environment also.
Natural resources are materials and components (something that can be used) that can be found within the environment. Every man-made product is composed of natural resources (at its fundamental level). A natural resource may exist as a separate entity such as fresh water, and air, as well as a living organism such as a fish, or it may exist in an alternate form which must be processed to obtain the resource such as metal ores, oil, and most forms of energy.
Environmental Pollution can be defined as any undesirable change in physical, chemical, or biological characteristics of any component of the environment i.e. air, water, soil which can cause harmful effects on various forms of life or property.
Pollution: The term pollution can be defined as influence of any substance causing nuisance, harmful effects, and uneasiness to the organisms
Pollutant: Any substance causing Nuisance or harmful effects or uneasiness to the organisms, then that particular substance may be called as the pollutant.
EnvironmentalPollutioncanbedefinedasanyundesirablechangeinphysical,chemical,or biological characteristics of any component of the environment i.e.air,water, soil which can cause harmful effects on various forms of life or property.
Water (prevention and control of pollution) act, 1974SURYAKANTVERMA2
AnActtoprovideforthepreventionandcontrolofwaterpollutionandthemaintainingorrestoringofwholesomenessofwater,for the establishment, with a view to carrying out the purposes aforesaid, of Boards for the prevention and control of water pollution,forconferringonandassigningtosuchBoardspowersandfunctionsrelatingtheretoandformattersconnectedtherewith.
“ Bioavailability-
means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action."
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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The prostate is an exocrine gland of the male mammalian reproductive system
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3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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1. INTRODUCTION TO
DOSAGE FORMS
By
Suryakant Verma
Assistant Professor
Department of Pharmaceutics
DR. K. N. MODI INSTITUTE OF PHARMACEUTICAL
EDUCATION AND RESEARCH, MODINAGAR
Mob. No. 9760989460
3. DOSAGE FORM OF DRUGS
Dosage forms are the means by which drug
molecules/APIs are delivered to sites of action within
the body to produce optimum desired effects and
minimum adverse effect.
Need of Dosage
Forms
Drug
Safety/Benefit
Patient
Safety/Benefit
4. Introduction
Dosage form (Medicines) = API + Excipients
The means (or the form) by which drug molecules are delivered to sites
ofaction within the body.
Drug (Active pharmaceutical ingredients )
Chemical compound intended for used in diagnosis, treatment
prevention, of disease.
OR
The Active Pharmaceutical Ingredient (API) is the part of any drug that
produces its effects.
Excipients
o Do not increase or affect the therapeutic action of the active ingredient.
o Inactive ingredients may also be referred to as inert ingredients or
excipients, and generally have no pharmacological effect.
o Examples of inactive ingredients include binding materials, dyes,
preservatives, and flavoring agents,sweetening agents,coloring agents
etc.
5. Direct clinical use of the active drug substances is rare:
Why??
API handling and Accurate dosing can be difficult or
impossible (e.g., potent drugs: low mg and µg doses).
API administration can be impractical/unfeasible because of
size, shape, smell/odour, taste and low activity.
Some API are chemically unstable in light, moisture,O2
API can be degraded at the site of administration (e.g., low pH
in stomach).
API may cause local irritations or injury when they are present
at high concentrations at the site of administration.
Administration of active substance would mean to have no
chance for modification (improvement) of its PK profile.
6. NEED OF DOSAGE FORMS
Provide safe and convenient delivery of accurate dosage.
Example – Tablets, capsules, syrups
Protection of a drug substances from atmospheric
oxygen or moisture. Example – Coated capsules,
sealed ampules
Protection of a drug substances from gastric acid after
oral administration. Example – Enteric coated tablets
Conceal bitter taste, or odor of a drug substances.
Example – Capsules, coated tablets, flavored syrups
Provide liquid preparation of drug that insoluble or
unstable in the desired vehicle. Example – Suspension
Provide liquid dosage forms of substances soluble in
desired vehicle. Example – Solution.
7. Provide optional drug action from topical administration
sites. Example – Ointment, cream, ear and nasal
preparations.
Provide for insertion of a drug into one of the body’s
orifices. Example – Rectal and vaginal suppositories.
Provide extended drug action through controlled release
mechanisms. Example – Controlled release tablets,
capsules, suspensions.
Provide for the placement of drugs within body tissues.
Example – Implants.
Provide for the optimal drug action through inhalation
therapy. Example – Inhalants.
8. CLASSIFICATION OF DOSAGE FORMS
Based on Route of
Administration
Oral
Parenteral
Topical
Transdermal
Respiratory/Inhaled
Ophthalmic
Rectal
Veginal
Otic
Based on Physical Form
Solid
Semi-solid
Liquid
Gases
16. NoseLung
Inhalation
Gases Liquids Aerosols Solids
Liquids Aerosols Semi-
solids
Solids
Vapors
Medical gases
Solution
Suspension
Emulsion
MDIs
DPIs
Other pressure systems
DPIs
Solution
Suspension
Emulsion
MDIs
Gels
Powdersfor
inhalation
INHALED DOSAGE FORMS
17. RECTAL & VAGINAL DOSAGE FORMS
RECTAL&
VAGINAL
Suppository
EnemaPessaries
18. SOLID DOSAGE FORMS
1 -TABLET
A tablet is unit dose of one or more medicament. Prepare by compression ormould
method.
Common excipients used in tablet are:
Diluents – Provide bulkiness of tablet.
Disintegrants – To ensure that the tablet breaks up in the digestive tract.
Binder – Important for granulation ofpowder.
Glidants and Lubricants – Provide good flow and ensure efficient tabletting.
Sweeteners and Flavors – Tomask the taste ofAPIs.
Pigments – Tomask uncoated tablets visually attractive.
A coating may be applied to mask taste, smooth tablet for easyswallow, expending
shelf life, and prevent gastric degradation of drug.
19. 2 - BUCCAL AND SUBLINGUALTABLET
Buccal tablets placing between the gum and the cheek.
Sublingual tablets placing under the tongue.
Medicaments of both systems rapidly dissolve in mouth and absorbed throughthe
mucous membrane of mouth.
Drug reaches in systemic circulation without affecting by gastric juicesand
metabolizing enzymes of the liver.
Examples – Vasodilators, Steroidal hormones.
20. 3 - EFFERVESCENT TABLET
Effervescent tablets are uncoated and generally contain acid substances(citric
and tartaric acids) and carbonates or bicarbonates , which react rapidly in
presence of water and release carbon dioxide.
They are intended to be dissolved or dispersed in water before use, it provide :
Tablet immediately dissolve or dispersed
Pleasant taste of carbonated drink
4 - CHEWABLETABLET
They are tablets that chewed prior to swallowing.
They are designed for administration to children e.g. vitamin products.
21. 5 - CAPSULES
Solid unit dosage form that contain a solid, semi-solid, and liquid fill and agelatin
shell.
Common excipients used in capsules are :
Gelatin – Commonly used as gelling agent.
Plasticizers – Toensure elasticity or mechanical stability.
AdditionalAdditives – Preservative, coloring and opacifying agents .
They are mainly two types are :
Hard gelatin capsules used for dry powder ingredients.
Soft gelatin capsules used for semi-solid and for active ingredients that are
dissolved or suspended in oil.
22. 6 - LOZENGE
It is a solid preparation that used to medicate the mouth and throat for the slow
administration of indigestion or cough remedies.
It consisting of sugar and gum, the latter giving strength and cohesiveness tothe
lozenge and facilitating slow release of the medicament.
7 - PASTILLES
It is a solid medicated pill or candy preparation that design to dissolve slowlyin
the mouth.
They are softer than lozenge and their base are glycerol, gelatin, acacia andsugar.
23. 8 - DENTALCONES
Atablet from intended to be placed in the empty socket following a toothextraction,
for preventing the local multiplication of pathogenic bacteria associated with tooth
extractions.
These tablets contain an excipients like – lactose, sodium bicarbonate, andsodium
chloride etc.
Cones may contain an antibiotic or antiseptic.
9 - PILLS
It is a solid oral dosage form which consists of spherical masses prepared from
one or more APIs with inertexcipients.
Pills are now rarely used.
24. 10 – ORALGRANULES
They are consisting of solid, dry aggregates of powder particles withirregular
shape often supplied in single-dose sachets.
Some granules are placed under the tongue and swallowed with water and other
are intended to be dissolved in water before taking.
Effervescent granules evolve carbon dioxide when added to water.
11 – ORALPOWDER
Bulk Powders are multi dose preparations consisting of solid, loose, dry particlesof
varying degrees of fineness.
Contain one or more active ingredients, with or without excipients and, if necessary,
coloring matter and flavoring substances.
Usually contain non-potent medicaments such as antacids since the patient measures
a dose by volume using a 5 ml medicine spoon.
25. LIQUID DOSAGE FORMS
1 – ORALSOLUTION
Oral solutions are clear Liquid preparations for oral use containing one or
more active ingredients dissolved in a suitable vehicle.
2 – ORALEMULSION
Oral emulsions are stabilized oil-in-water dispersions, either or both phases of which
may contain dissolved solids either oil is dispersed in finely divided form in water or
vice versa.
3 – ORALSUSPENSION
Biphasic liquid preparations for oral use containing one or more active ingredients
suspended in a suitable vehicle. It sediment which is readily dispersed on shaking to
give a uniform suspension which remains sufficiently stable to enable the correct
dose to be delivered.
26. 4 – SYRUP
It is a concentrated aqueous solution of a sugar, usually sucrose towhich
medicaments are added.
Flavored syrups are a convenient form of masking disagreeabletastes.
5 – ELIXIR
It is pleasantly flavored clear liquid oral preparation of potent or nauseousdrugs.
The vehicle may contain a high proportion of ethanol or sucrose togetherwith
antimicrobial preservatives which confers the stability of the preparation.
6 – MOUTHWASHES
These are similar to gargles but are used for oral hygiene and to treatinfections
of the mouth.
27. 7 – LINCTUSES
It is viscous, liquid oral preparations that are usually prescribed for the relief of
cough. It contain high proportion of syrup and glycerol which have a demulcent
effect on the membranes of the throat.
The dose volume is small (5ml) and, to prolong the demulcent action, they
should be taken undiluted.
8 – ORALDROPS
Oral drops are liquid preparations for oral use that are intended to be
administered in small volumes with the aid of a suitable measuringdevice.
They may be solutions, suspensions or emulsions.
28. 9 – GARGLES
They are prepared in a concentrated solution with directions for thepatient
to dilute with warm water before use.
They are aqueous solutions used in the prevention or treatment of throatinfections.
10 – LOTIONS
It is mono-phasic liquid preparations (aqueous) for external application without
friction either dabbed on the skin or applied on a suitable dressing and covered
with a water proof dressing to reduce evaporation.
11 – NASAL DROPS & SPRAYS
Drugs in aqueous solution may be instilled into the nose from a dropper or froma
plastic squeeze bottle.
Used for local effect, e.g. antihistamine, decongestant.
29. 11 – COLLODION
Collodion is a solution of nitro cellulose in ether or acetone, some timeswith
the addition of alcohols.
As the solvent evaporates, it dries to a celluloid-likefilm.
It is highly flammable.
Compound Wart Remover consists of acetic acid and salicylic acid inan
acetone collodion base used in treatment of warts by Keratolysis.
12 – PAINTS
Paints are mono-phasic liquids for application to the skin or mucous membranes.
Skin paints contain volatile solvent that evaporates quickly to leave adry
resinous
film of medicament.
Throat paints are more viscous due to a high content of glycerol that designed
to prolong contact of the medicament with the affectedsite.
30. PARENTERAL DOSAGE FORMS
An injection is an infusion method of putting liquid in to the body, usually witha
hollow needle and a syringe which is pierced through the skin.
Intravenous Injection
• It is a liquid administered directly into the bloodstream via a vein.
• It is advantages when a rapid onset of action is needed.
Intramuscular Injection
• It is the injection of aAPIs directly into a muscle.
• Intramuscular injections are often given in the deltoid,vastus
lateralis, ventrogluteal and dorsogluteal muscles.
Subcutaneous Injection
• It is injecting into the subcutis, the layer of skin directly below the
dermis and epidermis.
• It is highly effective in administering vaccines and insulin.
31. SEMI-SOLID DOSAGE FORMS
1 – OINTMENTS
Ointments are semi-solid, greasy preparations for application to the skin, rectum or
nasal mucosa.
Base is usually anhydrous and immiscible with skin secretions.
Ointments may be used as emollients or dissolved medicaments to the skin.
2 – GELS
In gel a liquid phase is constrained with in a 3-D polymeric matrix (consistingof
natural or synthetic gum) having a high degree of physical or chemical cross-
linking.
It is used for medication, lubrication and some miscellaneous applicationslike
carrier for spermicidal agents to be used intra vaginally.
32. 3 – CREAMS
Oil-in-water (O/W)
• It composed of small dropletsof
oil dispersed in a continuous
aqueous phase.
• Less greasy and more easily
washed off using water.
Water-in-oil (W/O)
• It composed of small droplets of
water dispersed in a continuous
oily phase.
• More difficult to handle butused
for hydrophobic drugpreparation.
• Reduces water loss fromthe
stratum corneum maintain
moisture of skin.
33. 4 – PASTES
Pastes are basically ointments into which a high percentage of insoluble solidhas
been added.
The extra ordinary amount of particulate matter stiffens the system.
It provide less heating and penetration than ointment.
It make good protective barrier when placed on the skin, the solid theycontain
can absorb and thereby neutralize certain noxious chemicals before they ever
reach the skin.
GreasyPastes
• Leaser’spaste
Non-greasyPaste
• Bassorinpaste
34. INHALED DOSAGE FORMS
1 – INHALER
Inhalers are solutions, suspensions or emulsion of drugs in a mixture of inert
propellants.
Release of a dose of the medicament under pressure in an aerosol dispenser in the form
of droplets of 50 um diameter or less from the container through a spring loaded valve
incorporating a metering device.
It is commonly used in the treatment of asthma and other respiratory problems.
35. 2 – NEBULIZER OR ATOMIZER
It is commonly used in treating asthma, and other respiratory diseases.
It is a device used to administer medication in forms of a liquid mist to the air ways.
It pumps air or oxygen through a liquid medicine to turn it into a vapor, which isthen
inhaled by the patient.
Generally prefer to inhalers for patients, due to advantages suchas:
1- Cheaper
2 More portable
3 Less risk of side effects.
For that reason, are usually reserved only for serious cases of respiratory disease or
severe attacks.
36. RECTAL & VAGINAL DOSAGE FORMS
1 – SUPPOSITORY
It is a semi solid medicated mass, usually cone shaped, that isinserted
either into the rectum, vagina where it melts at body temperature.
2 – ENEMA
An enema is the procedure of introducing liquids into the rectumand
colon via the anus.
Evacuant Enema
• Used as a bowel stimulant to treat
constipation.
• Their volume up to 2 liters.
• Warmed to body temperature.
• Example - soft soap enema&
Magnesium sulphate enema
Retention Enema
• Their volume does not exceed100
ml.
• No warming needed.
• Example – barium enema &
nutrient enema.
37. 3 – PESSARY
Pessaries are solid medicated preparations designed for insertion
into the vagina where they melt or dissolve.
Moulded
Pessaries
• Cone shape and
prepared by
molded method.
Compressed Pessaries
• Prepare by compression
as similar manner to oral
tablets.
• Available indifferent
shape.
Vaginal
Capsules
• Prepare sameas
soft gelatin
capsules and
various sizeand
shape.