Physical Pharmacy and Pharmaceutics PDF

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 an...

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 12  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 20 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 28  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 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