Introduction to Pharmaceutical Technology PDF

Introduction to Pharmaceutical Technology By: Asst. Lect. Asmaa M. Rashid Ref: Ansel’s pharmaceutical dosage forms and drug delivery systems  Introduction to Pharmaceutical Technology In this course the following subjects will b...

Introduction to Pharmaceutical Technology By: Asst. Lect. Asmaa M. Rashid Ref: Ansel’s pharmaceutical dosage forms and drug delivery systems  Introduction to Pharmaceutical Technology In this course the following subjects will be covered: Solutions and types of solutions Solubility, factors affecting solubility, Aqueous solutions containing aromatic waters Syrups Spirits and elixirs Dispersed systems definitions , their classification Colloidal systems, suspension Extraction, maceration and percolation Tinctures, fluid extracts  What is a DRUG How does the law define a drug? The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines drugs, as an agent intended for use in the diagnosis , mitigation, treatment, cure, or prevention of disease in humans or in other animals. This is pharmacologically active ingredient in the medicine.Also called Medicinal agent Active ingredient Active pharmaceutical ingredient (API)  Cont…  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 in the production of drugs and pharmaceutical products.  Organized sets of monographs or books of these standards are called pharmacopeias or formularies  Pharmaceutics Pharmaceutics is the science and technology of the design and manufacture of dosage form, this covers :  Physical pharmaceutics (the drug itself)  Biopharmaceutics (therapeutic consideration)  Dosage form design  Manufacture of these medicines either on small scale (compounding) or on large scale (industrial)  Avoidance and elimination of Microorganisms. Pharmacopeia The term comes from the Greek Pharmakon = meaning drug Poiein =meaning make Pharmacopeia , is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. Descriptions of preparations are called monographs. In a broader sense it is a reference work for pharmaceutical drug specifications.  British Pharmacopeia BP The British Pharmacopeia is the official collection of standards for UK medicinal products and pharmaceutical substances The standards are established by the British Pharmacopeia Commission. Canada and Australia also use the BP as their official standard The United States Pharmacopeia (USP) established in 1820, contains legally recognized standards of identity, strength, quality, purity, packaging, and labeling for drug substances, dosage forms, and other therapeutic products, including nutritionals and dietary supplements The National Formulary (NF), established in 1888 by the American Pharmaceutical Association, includes standards for excipients, botanicals, and other similar products, gives the composition, description, method of preparation, and dosage for drugs Descriptions of preparations are called monographs.  Monograph  USP-NF monographs contain specifications: (tests, procedures, and acceptance criteria) that helps ensure the strength, quality, and purity of named items. The USP-NF also contains general approaches to ensure the quality of compounded preparations  Pharmaceutical Technology: Is the science that deals with preparing different dosage forms with respect to their raw materials, compositions, methods of preparations, stability, storage and uses. Dosage Form: Is a preparation formulated to make possible the administration of medication in prescribed or measured amounts, the dosage form contains both active ingredient and excipients. The dosage form should be: 1. Safe 2. Effective 3. Stab  Types of dosage forms solid liquid semisolid dosage dosage dosage forms (e.g. forms (e.g. forms (e.g. solutions, tablets, syrups, ointments capsules, suspensions, and powders). emulsions). creams). Think ???? What are the advantages of different dosage forms ???? 1. For the protection of a drug substance from the effect of atmospheric oxygen or humidity-------- (coated tablets, ampules). 2. For the protection of a drug substance from the destructive effect of gastric acid or enzymes or to protect the stomach from irritation caused by drugs------ - (enteric coated tablets or capsules). 3. To overcome the bitter, salty taste or disagreeable odor of some drugs------- - (capsules, coated tab., syrups). 4. To prolong the action of drug substance--------- (sustain release tab. or cap.). 5. for direct administration of drug in to blood stream ---------- (inj.). 6. To provide topical administration of drugs -------- (oint. and creams). 7. To provide dosage forms used in the treatment of eye, nose, and ear infection or inflammation(local) (drops). 8. For insertion in to body orifices or cavities -------(rectal and vaginal supp.).  Solution  In physicochemical terms, solutions may be prepared from any combination of a solid, liquid, and gas, the three states of matter.  In pharmaceutical terms, solutions are “liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents”.  Mixture of two or more substances that are homogenously mixed (true solutions). Classification of Solution depending on 1- depending on their method of preparation 1-Solutions prepared by simple solution 2-Solution prepared by chemical reaction 3- Solutions prepared to be sterile and pyrogen-free and intended for parenteral administration are classified as injections.. 4- Solutions prepared by extracting active constituents from crude drugs are termed tinctures or fluidextracts,. 2- Route of administration Oral Otic , nasal Vaginal , Ophthalmic rectal solutions Topical Injectable ( Oral topical Irrigation mouthwash)  3-According to their composition Sweet thick oral solution Syrup Contains sucrose Must be sterile, isotonic and buffered Injections Aqueous or non aqueous Hydro-alcoholic oral solutions Elixir Sweetened are alcoholic or hydro-alcoholic solution of aromatic Spirits material Aromatic water the solvent is water Fluid extracts Plant or chemical origin Tinctures Differ in concentration of the extract 4-Types of solutions 1- Solution of liquid in liquid :  When two liquids such as water/alcohol are mixed, a homogenous system is formed irrespective of the proportions (miscible)  When phenol /water are mixed a homogenous system only formed when mixed in a certain proportion (miscible in certain proportion).  When mineral /water are mixed no system is formed when mixed at any proportion (immiscible). 2- Solution of solid in liquid. Most of true solutions are example of solid in liquid solution. 3- Solution of gas in liquid.The solubility of gas in liquid is described by Henry’s Law which state that the solubility of gas isproportional to the pressure if the temperature remain constant provided that the gas is only slightly soluble  Advantages disadvantages Easy to swallow , Bulky, taste flow, apply , spray masking Stability Good absorption M.O. growth Patient homogenous measurement  Solubility  Attractive forces between atoms lead to the formation of molecules and ions. The intermolecular forces, which are developed between like molecules, are responsible for the physical state (solid, liquid, or gas) of the substance under given conditions, such as temperature and pressure.  When molecules interact, attractive and repulsive forces are in effect. The attractive forces cause the molecules to cohere, whereas the repulsive forces prevent molecular interpenetration and destruction. When the attractive and repulsive forces are equal, the potential energy between two molecules is minimal and the system is most stable.  Dipolar molecules frequently tend to align themselves with other dipolar molecules so that the negative pole of one moleculepoints toward the positive pole of the other.  Large groups of molecules may be associated through these weak attractions, known as dipole–dipole or van der Waals forces.  Cont…  Other attractions also occur between polar and nonpolar molecules and ions. These include ion– dipole forces and hydrogen bonding.  Because of small size and large electrostatic field, the hydrogen atom can move in close to an electronegative atom, forming an electrostatic type of association, a hydrogen bond or a hydrogen bridge. Hydrogen bonding involves strongly electronegative atoms such as oxygen, nitrogen, and fluorine. Such a bond exists in water and also exist between some alcohol molecules, esters, carboxylic acids, aldehydes, and polypeptides.  Solubility  The solubility of an agent in a particular solvent indicates the maximum concentration to which a solution may be prepared with that agent and that solvent. i.e, Amount of a solute dissolved in a solvent at a certain temperature(degree of solubility) . When a solvent at a given temperature has dissolved all of the solute possible, it is said to be saturated.  When excess of solid (solute) is shaken with liquid (solvent) for a period of time a maximum amount of it will be dissolved (saturated solubility).  When excess amount of solute is added to saturated solution and the temperature is increased, more of solute will be dissolved (super saturated solution)  Solubility Expressions The solubility of a drug may be expressed in a number of ways.  The United States Pharmacopeia (USP) describes the solubility of drugs as parts of solvent required for one part solute. (PP)  Solubility is also quantitatively expressed in terms of molality, molarity, and percentage (w/v). The USP describes solubility using the seven groups listed in Table -1.  The European Pharmacopoeia lists six categories (it does not use the practically insoluble grouping).  Table (1):Relative terms of solubility Description Forms Parts of Solvent Solubility Range Solubility Required (mg/mL) Assigned (mg/mL) Very soluble (VS) 1000 1000 Freely soluble (FS) From 1 to 10 100–1000 100 Soluble From 10 to 30 33–100 33 Sparingly soluble From 30 to 100 10–33 10 (SPS) Slightly soluble (SS) From 100 to 1000 1-10 1 Very slightly soluble From 1000 to 10,000 0.1–1 0.1 (VSS) Practically insoluble >10,000