PRINCIPLES OF DOSAGE FORM AND DEVELOPMENT A.

INTRODUCTION TO DRUGS AND PHARMACY PHARMACY : defined as a health profession duly concerned with the preparation

and distribution of medical products embracing not only the art and science of preparing from natural and synthetic resources, materials for the prevention, diagnosis or treatment of diseases but all the professional, legal and economic function of distributing medicinal products properly and safety.
DRUGS means: 1. articles intended in the current official United States PharmacopeisNational Formulary(USP-NF), official Homeopathic Pharmacopeia of the United States, Official Philippine National Drug Formulary(PNDF) or any supplement to any of them , 2. articles intended for use to diagnosis, cure, mitigation, treatment or prevention of disease in man or animals 3. articles (other than food) intended to affect the structure or

function of the body of man or animals and 4. articles intended for use as a component of any articles specified in clauses 1,2 0r 3 but do not include devices or their components, parts or accessories Qualities of the drugs: - diversity of their actions and effects on the body which enables their selective use in the treatment of a range of common and rare conditions involving every body organ, tissue and cell. stimulate the cardiac muscle, CNS or GIT opposite effects like mydriatic drugs (dilate the pupil) or miotics (constrict or diminish size of the pupil) drugs that render blood more or less coagulable increases the hemoglobin content diuretic drugs that increases flow if urine expectorant drugs which increases respiratory tract fluid Classification of Drugs: 1. Prescription of Ethical drugs: pharmaceutical products or drug preparation that are to be dispensed only upon written of a validly-registered licensed physician, dentists and veterinarians

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2. Non-prescription or over the counter drugs (OTC)- pharmaceutical products Or preparations that can be dispensed without a written order of a validlyregistered licensed physician, dentist or veterinarian for the use of consumers for the prevention or symptomatic relief of minor or self limiting ailments.
3. Dangerous drugs includes the Narcotic drugs and Psychotropic drugs

New drugs may be derived from plant or animal sources. The process of drug discovery and development is complex through collective Contributions of many scientific specialistslike chemist, biochemist, bacteriologist, physiologist, pharmacologists, toxicologists, hematologists pharmaceutical scientists, clinical pharmacists, physicians and many others. After new drug substance is discovered the pharmacology is determined which determine the nature and mechanism of action of the drug on biologic system and the toxicologic features. The drugs site and rate of absorption, its pattern of distribution and concentration within the body, its duration of action and the Method and rate of elimination or excretion must be studied. The most effective routes of administration must be determined and guidelines for the dosage must be recommended for persons of varying ages, weights and states of illness have to be established Each particular pharmaceutical product is a formulation unique unto itself. In addition to the active therapeutic ingredients, it contains a number of nontherapeutic or pharmaceutical ingredients which includes such materials as fillers, thickeners, solvents, suspending agents, tablet coatings and disintegrants.It is through these that formulation achieves its unique composition and characteristics physical appearance. The principles of chemistry, physical pharmacy, microbiology and pharmaceutical technology to ensure the stability of a drug for the effectiveness of the drug through physical and chemical compatibility of the pharmaceutical ingredients and the packaging materials. The formulation must be preserved against decomposition due to chemical degradation and protected from microbial contamination and the destructive influences of exce4ssive heat, light and moisture.

The therapeutic ingredients must be released from the dosage form in the proper quantity and in such a manner that the onset and duration of the drug action are desired. The pharmaceutical product must tend itself to efficient administration and must possess attractive features of flavor, color, odor and texture that enhance acceptance by the patients. Finally the product must be effectively packaged and clearly and completely Labeled according to legal regulations.. The pharmaceutical product must be properly administered in sufficient quantity at interval and indicated duration to achieve therapeutic outcomes. Before medication, patient is advised of any expected side effects as to the food, Beverages and other drugs that may interfere with the effectiveness of the medication. Through professional interaction and communication with other health professionals, the pharmacist can contribute greatly to patient care. An intimate Knowledge of drug action, pharmacotherapeutics. Formulation and dosage form design , available pharmaceutical products and drug information sources makes pharmacist a vital member of the health care team. The pharmacist is entrusted is entrusted with the legal responsibility for the procurement ,storage, control and distribution of effective pharmaceutical products and for the compounding and filling of prescription orders. INTRODUCTION OF THE SCIENTIFIC VIEWPOINT Hippocrates, Greek physician and Father of medicine for his description of hundreds of drugs Dioscorides, a Greek physician and botanist who wrote De Materia Medica. Describe the art of identifying and collecting natural drug products which include Opium, ergot and hyoscyamus which are use in medicine Claudius Galen, a Greek pharmacist-physician who described numerous drugs of natural origin with a drug formulas and methods of compounding. He introduced The Galenic pharmacy.

EARLY RESEARCH Swede Karl Wilhelm Scheele(1742-1786) , most famous of all pharmacist because of his scientific genius and dramatic discoveries of lactic acid, citric acids. Oxalic acids, tartaric acid and arsenic acid. He indentified glycerin, new methods of Preparing calomel and benzoic acid and discovered oxygen a year before Priestley Friedrich Serturner, a German Pharmacist(1783-1841) isolated morphine from opium. In 1805 he isolated quinine and cinchonine from cinchona and strychnine and brucine from Nux vomica with Joseph Caventou and Joseph Pelletier Pelletier with Pierre Robiquet isolated caffeine and Robiquet separated codeine from opium. The extraction and isolation of active constituents from crude drugs (unprocessed) botanical drugs led to the development of dosage form of uniform strength containing single effective therapeutic acid from natural origin. In 1821, the Philadelphia College of Pharmacy was established as the nations First school of Pharmacy. In 1820 the United States Pharmacopeia (USP) was created to aid in establishing standards for drugs in the US. DRUG STANDARDS Books of standards fro drugs and drug products known as pharmacopoeia and Formularies are collectively referred to as drug compendia. 1. The United States Pharmacopeia and the National Formulary The term pharmacopeia comes from the Greek words pharmakon meaning drug and poiein meaning make and indicates any recipe or formula or other standards require to make or prepare a drug. The first USP was published on Dec. 20, 1820 and on the other hand, the 1st NF was published in 1888. Among the objectives of the pharmacopeia is to standardize the names and formulae of extensively used drugs, to provide standards and tests for the identity, purity and quality of drugs in the US or its possessions. Prior to 1940, the USP and the NF was based every 10 yrs. After that date, new editions appeared every 5 years with supplements issued periodically as necessary. On Jan. 2, 1975, the US Pharmacopeial Convention Inc.,purchased from the American Pharmaceutical Association the NF thus unifying the official compendia and thereby providing the mechanism for a single national compendium. The first combined compendium, representing the USP XX and NF XV became official July 1, 1980. All monographs on therapeutically active drug substance appeared in the USP section of the volume here as all monographs pharmaceutical agents appeared in the NF section.

The USP 23, NF 18 became official in 1905 was the first edition to drop the use of roman numerals to indicate the edition. The USP/NF became the an annual publication in 2002 with USP25-NF 20 And the 2003 edition USP 31-NF 20 contains approximately 4,240 drug monographs and more than 220 General Tests and Assays. USP AND NF MONOGRAPHS Adopt standards for drug substances, pharmaceutical ingredients and dosage forms in the current practices of medicines and pharmacy and provide suitable tests and assay procedures. The monograph consists of: 1. official title (generic or non-proprietary name) 2. graphic or structural formula 3. empirical formula 4. molecular wt. 5. established chemical names 6. chemical purity 7. toxic nature of the agent 8. packaging and storage recommendation 9. chemical and physical tests 10.method of assay 2. Other Pharmacopoeias and Drug Standards Homeopathic Pharmacopoeia of the United States and the International Pharmacopoeia (IP) provide additional guidelines for drug quantity require by certain practitioners and agencies The term HOMEOPATHY was coined by Samuel Hahnemann from the Greek homois, meaning similar and pathos meaning disease.