Physical Pharmacy

and
Pharmaceutics

1
 The science and technique of preparing and
dispensing drugs.
 A drug is defined as an agent intended for use in
diagnosis, treatment or prophylaxis of diseases.
 Drug design
 Pharmacological testing
 Formulation and drug delivery
 Preclinical studies
 Clinical studies
 Manufacturing
 Registration and marketing
 Dispensing and follow up
 Medicinal chemistry and pharmacognosy
 Pharmacology
 Pharmaceutics
 Pharmacy practice
 Pharmaceutics:
 The general area of study concerned with the
formulation, manufacture, stability and
effectiveness of pharmaceutical dosage
forms.
 Dosage forms are composed of medicinal
agents and non-medicinal agents
(excipients).
 Pharmaceutics
Pharmaceutics converts a drug into a
medicine.
 The potent nature of some drugs (fillers)

Drug Dose (mg)

Alprazolam 0.5
Colchicine 0.5
Nitroglycerin 0.4
Digoxin 0.25
Levothyroxin 0.1
Misoprostol 0.1
Ethinyl 0.05
estradiol
 As a vehicle for drug substances
 To protect the drug (atmospheric oxygen,
humidity or gastric acid)
 To mask the taste or odor of drug substances
 To control the drug release
 To enhance the permeation of topical
preparations
 Nature of illness
 Age of the patient
o Liquid formulation with liquid dispenser
o More distinctive dosage forms
 Emergency cases
 Motion sickness, nausea and vomiting
 Route of administration
Oral Parenteral Epicutanuous/
Tablets Solutions Transdermal
Capsules Suspensions
Solutions Ointments
Syrups Creams
Elixirs
Rectal Gels
Suppositories Lotions
Suspensions
Solutions Plasters
Ocular Ointments
Solutions
Suspensions
Ointments
 Diluents or fillers (to increase the bulk of the
formulation)
 Binders (to cause adhesion of the powdered
drug)
 Disintegrants (to promote table break up)
 Preservatives (to prevent microbial growth)
 Colorants (for more distinctive appearance)
 Flavors and sweetners (to make the product
more palatable)
 Ointment base (semisolid vehicle for medicated
ointments)
 Permeation enhancers (to promote the permeation of
topically applied drugs across biological membranes)
 Aerosol propellants (for developing the pressure
within an aerosol container)
 Table 4.3. Examples of pharmaceutical
ingredients
 Ansel’s Pharmaceurtical Dosage Forms and
Drug Delivery Systems
 Handbook of Pharmaceutical Excipients
 Formulation depends on the physicochemical
properties of the drug and the administration
site.
 Pharmaceutical and formulation considerations
 Biopharmaceutical and pharmacokinetic
considerations
 particular pharmaceutical product containing active and
inactive pharmaceutical ingredients formulated into the
particular dosage form.

 Two major types of PP according the origin:

 Manufactured in large scales by pharmaceutical

industry(original and generic preparations).

 Compounded individually in compounding

pharmacies

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 Physical state
 Drug administration
Solutions
Suspensions
Emulsions

 the solubility or miscibility in a liquid vehicle

15
One homogenous phase, prepared by
dissolving one or more solutes in a solvent.

16
Solutions can be formulated for different routes
of administration
Orally:
Syrups, elixirs, linctuses, drops
Parenterally :
Intravenous , Intramuscular, Subcutanuous
In mouth and throat:
Mouth washes, gargles
In body cavities:
Douches, enemas
On body Surfaces:
eye drops, ear drops, nasal sprays
 A dispersion system consisting of two immiscible
liquids
 o/w orw/o
 cloudy appearance

Oil

Water

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Suspensions
 A dispersion system where solid particles are
dispersed in liquid phase.
 According to the size of dispersed particles: colloidal
and coarse dispersions can be distinguished.
 May require shaking before administration.
 Ointments:
 Semisolid dosage forms with the oleaginous (hydrocarbon),
water-soluble or emulsifying base.
 Pastes:
 Semisolid dispersion system, where a solid particles (> 25%, e.g.
ZnO) are dispersed in ointments.
 Creams:
 Semisolid emulsion systems (o/w, w/o) containing more than 10%
of water.
 Gels:
 Aqoeous semisolid dossage form contains polymeric
macromolecules
 Suppositories:
 Designed for rectal administration where either melt or
dissolve at body temperature.
 Pessaries:
 Special type of suppositories for vaginal
administration.
 Powder
 Bulk or divided.
 Tablet
 Compressed powder or granules.
 Capsules
 The drug is inclosed within either a hard or soft shell.
 Implants
 Sterile disks inserted surgically into body tissues.
 Nebulizers
 Turns liquid medicine into a mist for inhalation.
 Aerosoles
 pressurized dosage forms that upon actuation emit a
fine dispersion of the drug in a gaseous medium.
 Sprays
 Metered dose inhalers
 Conventional (unmodified) release of API
 Novel drug delivery systems
Controlled release
Targeted distribution

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 The term pharmacopeia comes fromthe
 Greek pharmakon, meaning drug,
 and poiein, meaning make,
 and the combination indicates any recipe or
formula or other standards required to make or
prepare a drug.
•Published by the authority of a government or a
medical or pharmaceutical society
 As the scientific basis for drugs and drug
products developed, so did the need for
uniform standards to ensure quality. This
need led to the development and publication
of monographs and reference books
containing such standards to be used by
those involved in the production of drugs and
pharmaceutical products. Organized sets of
monographs or books of these standards are
called pharmacopeias or formularies.
 A quality specification is composed of a set of
appropriate tests that will confirm the identity and
purity of the product, ascertain the strength (or
amount) of the active substance and, when needed, its
performance characteristics.
 General requirements may also be given in the
pharmacopoeia on important subjects related to
medicines quality, such as analytical methods,
microbiological purity, dissolution testing,
stability, etc.
USP (United States Pharmacopeia)
BP (British Pharmacopeia)
EP (European Phrmacopeia)
IP (International Pharmacopeia)
JP (Japanease Pharmacopeia)
 General notices
 Addresses general issues applicable to all texts
 Provide basic information (e.g. conventional expressions)
 General chapters
 Provide standard methods that can be used where there is no
monograph
 Avoid repeating standard methods
 Provide general requirements for equipment and equipment
verification
 Individual monographs
 Description
 Identification
 Tests
• Purity tests
• Assay tests
Monograph dosage form
 The current edition of the British Pharmacopoeia comprises
the following volumes:
 Volume I and II contain monographs for medicinal substances.
 Volume III contains general monographs formulated preparations and
specific monographs,
 Volume IV contains
 Herbal drugs, herbal drug preparations and herbal medicinal products
 Materials for use in the management of homoeopathic preparations
 blood related products, immunological products, radiopharmaceutical
preparations, surgical materials & homoeopathic preparations.
 Volume V
 supplementary chapters, IR spectra, Appendices and index.
 Volume VI contains veterinary.
 The BP 2017 includes almost 4,000 monographs;
which contain monographs for drug
substances, excipients, and formulated preparation,
together with supporting General Notices,
Appendices (test methods, reagents etc.), and
Reference Spectra; used in the practice
of medicine, all comprehensively indexed and
cross-referenced for easy reference. Items used
exclusively in veterinary medicine in the UK are
included in the BP (Veterinary).
 BNF Publications are published jointly by the British
Medical Association and the Royal Pharmaceutical Society.
They are independent resources that do not market
medicines.
 The British National Formulary (BNF) is a United
Kingdom (UK) pharmaceutical reference book that
contains a wide spectrum of information and advice
on prescribing and pharmacology, along with specific facts
and details about many medicines available in the UK.
Information within the BNF includes indication(s),
contraindications, side effects, doses, legal classification,
names and prices of available proprietary and generic
formulations, and any other notable points.
 The United States Pharmacopeia and The National
Formulary (USP–NF) is a book of public pharmacopeial
standards for chemical and biological drug substances,
dosage forms, compounded preparations, excipients,
medical devices, and dietarysupplements.
 It has been printed in three volume set.
 Volume I contains generalchapters
 Volume II & III contains monographs.
 Pharmaceutical Calculations in Prescription
Compounding: USP General Chapter <1160> provides
guidance for appropriately performing the necessary
calculations for compounding and dispensing
medications.
 The chapter provides information for a variety of
determinations, including quantities of ingredients,
dosages, infusion rates, endotoxin load, stability and
expiration dates, and provides illustrative sample
calculations.
Include the following:
 Formulas (ingredients and quantities)
 Directions to correctly compound the preparation
 Beyond-use dates based on stability studies
 Packaging and storage information
 Acceptable pH ranges
 Stability-indicating assays
 The International Organization for Standardization
(ISO) is an international consortium of representative
bodies constituted to develop and promote uniform or
harmonized international standards.
 Among the various ISO standards used in the
pharmaceutical industry are those in the series ISO
9000 to ISO 9004. Included here are standards
pertaining to development, production, quality
assurance (QA), quality control (QC), detection of
defective products, quality management (QM), and
other issues, such as product safety and liability.
 Pharmaceutical Journals
 (e.g. The International Journal of Pharmaceutics)

 Data bases:
 Google scholar
 Science direct
 Pubmed (medline)
 Sopus
 Web of science
 Published articles
 Review article
 Research article
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusion
 Others:
 TOXNET®
 DRUGBANK