PPH 203 Pharmaceutics I Lectures One PDF

Pharmaceutics I PPH 203 Lecture 1 Professor/ Gihan Labib  Course Description This course is a study of the system of weights, measures, mathematical expertise and pharmaceutical calculations requisite to the compounding, dispensing, and utilization of drugs in pharmacy practice....

Pharmaceutics I PPH 203 Lecture 1 Professor/ Gihan Labib  Course Description This course is a study of the system of weights, measures, mathematical expertise and pharmaceutical calculations requisite to the compounding, dispensing, and utilization of drugs in pharmacy practice. It is also concerned with all aspects of formulation, packaging, storage and stability of liquid dosage forms including solutions (aqueous and non-aqueous), suspensions, emulsions and colloids with emphasis on the technology and pharmaceutical rationale fundamental to their design and development. Some incompatibilities occurring during dispensing are also covered.  Course Topics PPH-203-Pharmaceutics I Types of Liquid dosage forms (Solutions+ disperse systems ( Colloids, Suspensions & Emulsions) Types of additives used Formulation consideration & Incompatibilities Basic Pharmaceutical Calculations  Course Instructors Prof. Gihan Assoc. Prof. Salah Mohamed Lamiaa Heikel Labib  Textbooks -Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, Eighth Edition, Loyed V.Allen Jr, Nicholas G. Popovich and Howard C. Ansel, David B. Troy editor (10th Edition), Lippincott Williams & Wilkins 2013. -Pharmaceutics: The Design and Manufacture of Medicines. By Michael E. Aulton, Kevin M.G., Taylor editor, editors, 4th Edition, Churchill Livingstone 2013. -Pharmaceutical compounding and Dispensing, John. F. Marriott, Keith A. Wilson, Christophr A. Langley and Dawn Belcher, Pharm. Press, London, 2010. -Ansel, Howard C. Pharmaceutical Calculations. 14th ed. Lippincott Williams & Wilkins 2013 - https://www.ekb.eg/web/guest/resources?sourcesLang=en  Assessment Plan (3 Credit hours) Course Title: Pharmaceutics I, Course Code: PPD201 Credit hours: 3hrs, Marks: 100 15%: Midyear exam 7th week (15 Marks) 45%: Course Work ( Practical Labs & Exams + activities + quizzes) (45 Marks) 40%: Final Exam (40 Marks)  Important Points to consider Attendance according to the announced timetable on Campus You are divided into Groups Lectures (Wednesday 9:00 am- 10:30 am at Ground floor- B11-127) 12:00 pm- 1:30 pm Ground floor- B11-127) The Practical attendance (According to time table) Canvas platform: Should join through AIU email only Dr. Gihan Labib 9/25/2024 8  Professor/ Gihan Salah Labib Office: 2nd floor B09-3040 OFFICE HOURS Wednesday from 10:45- 11: 45 am  ILO’s “Liquid dosage forms” After these lectures the student should be able to: Recognize the basic definitions and types of various disperse systems. Understand basics of compounding for selected liquid dosage forms (solutions, colloids, suspensions& emulsions). Identify colloidal systems, their types, preparation and stability. Recognize the fundamental pharmaceutical processes in formulation of liquid dosage forms Identify and compare the characteristics of different liquid pharmaceutical preparations /disperse systems  ILO’s “Liquid dosage forms” Analyze the role of different excipients in liquid pharmaceutical preparations Solve and interpret formulation problems and incompatibilities Identify the medical use of some prescription components and suggest the appropriate patient counseling and storage conditions  CLASSIFICATION OF PHARMACEUTICAL Liquid Dosage Forms  According to the Dispersed System Colloids Polyphasic Suspensions system Liquid D.F Emulsions Monophasic Solutions system  According to Route of Administration Syrups Orally Elixirs Drops Mouth & Mouthwashes Throat Gargles Throat sprays Douches Enemas (Rectal) Body cavities Otic or Aural (ear) Nasal Ophthalmic Parentrals (Ocular)  According to the Vehicle Aqueous Non- aqueous solutions solutions Alcoholic Water (spirits) Hydroalcoholic (elixir) Aromatic water Ethereal (collodions) Glycerins Extracts ( Glycerites) Oleaginous Oleo-vitamins liniment  Solutions Monophasic Liquid Dosage Forms  DEFINITION OF SOLUTION Homogenous one-phase system consisiting of two or more components. Consist of : » Solute The component which is dispersed as small molecules or ions in the solvent » Solvent The phase in which dispersion occurs Generally Amount of Solute < Solvent Except Pharmaceutical Syrup contains 66.7% w/w sucrose as the solute in 33.3% w/w water as the solvent  Solid, liquids and gases can be both solvent & solute, in any combination Examples of Solute solutions Gas Liquid Solid Naphthalene Oxygen and other Water vapour Gas slowly gases in nitrogen (air) in air sublimes in air Solvent Carbon dioxide in Ethanol in Sucrose in Liquid water water water Hydrogen dissolves Hexane in Solid Metal alloys rather well in metals paraffin wax  Solutions as a Liquid dosage form » A homogenous liquid preparation that contains one or more dissolved medicaments in a suitable solvent or mixture of miscible solvents » Liquid dosage form is prepared by dissolving the active ingredient(s) in an aqueous or non aqueous solvent (oily or alcoholic) intended to be used either internally or externally  VEHICLE » The medium (solvent) which contains the ingredients of a medicine » The choice of a vehicle depends on the intended use of the preparation and on the nature and the physicochemical properties of the active ingredients Advantages and Disadvantages of Solutions as an Oral Dosage Form  ADVANTAGES 1. Easier to swallow than solid dosage forms (Tablets and capsules) acceptable for paediatric (children) and geriatric use (elderly people) 2. A drug is in solution so immediately available for absorption Disintegration and dissolution as a prerequisite for drug absorption from tablets  ADVANTAGES 3. Homogenous system with a uniform distribution of the drug More uniform dose than suspension and emulsion which need shaking 4. Immediately diluted by the gastric contents Reduce irritation to the gastric mucosa caused by high local concentration of some drugs (aspirin, KCl) if administered as a solid dosage form  DISADVANTAGES 1. Liquids are bulky Inconvenient to transport and store, and immediate lose of the whole product occurs in case of breakage of the container 2. Poor stability of the ingredients in aqueous environment of solutions Important for drugs susceptible to hydrolysis The shelf life of a liquid dosage form is much shorter than that of corresponding solid preparation 3. Provide suitable media for the growth of microorganisms Require the incorporation of a preservative  DISADVANTAGES 4. Accurate dosage will depend on patient’s ability to use the 5 ml spoon Inaccurate dosing may lead to loss of the therapeutic efficiency Most liquid preparations are designed for normal dosage of the drug is present in 5 ml or a multiple of 5 ml 5. The unpleasant taste of drugs is more pronounced in solutions Sweetening agents & flavours are used to make them more palatable  FORMULATION OF PHARMACEUTICAL SOLUTIONS Drug(s) Liquid Additive D.F Vehicle Solubility and stability are the two key characteristics that need to be considered when compounding solutions  Solubility 1. Will the drug dissolve in the solvent ? 2. What quantity of drug will dissolve? 3. Will the drug remain in solution and for how long? 4. What is the pH of solvent required ?  Stability of Solutions » A solution must retain its clarity, color, odor, taste and viscosity over its shelf life » Chemical and physical interaction that may take place between constituents must be taken into account as it will affect preparation stability Example: Ester of p-hydroxybenzoic acid (paraben) (preservative) have a high tendency to partition into certain flavoring oils Quality Control Tests  Visual examination Clarity Optical density after agitation Tested visually Color Spectrophotometricaly Equipment suitable for Viscosity measuring rheological properties  Chromatographic method Flavors Olfactory and Gustatory sensation tests Drug Method of drug analysis e.g. spectophotometric, content HPLC, GC---etc  CHOICE OF VEHICLE fOR SOLUTIONS Aqueous Non-aqueous  Aqueous vehicles Aromatic Non- Water water medicated syrup  WATER Water is the most widely used vehicle for pharmaceutical products WHY? Physiological compatible and lack of toxicity Naturally occurring water is impure dissolved inorganic salts usually sodium, potassium, calcium, magnesium and iron, chlorides, sulfates and bicarbonates Dissolved & undissolved organic matter Microorganisms  Types of Pharmaceutical Water 1. Potable water (Tap water or Drinkable) 2. Purified water (USP) 3. Water for injections (USP) 4. Sterile water for injections (USP) 5. Bacteriostatic water for injection (USP)  1. Drinkable water (Tap water) Acceptable drinking water: clear, tasteless, odorless, lack of pharmacological activity, neutral and very cheap. Pretreatment is required to prepare drinking water. Potable water contains < 0.1% total solids. Potable water is not permitted for the dispensing of most pharmaceutical dosage forms Why? » Bacterial contamination & the presence of dissolved salts may result to possible chemical incompatibilities » It could be used to wash pharmaceutical equipment, before final rinse with purified water. 2. Purified water ( USP) Prepared using potable water meeting the EPA (Environmental Protection Agency) standards The aim is the removal of dissolved solids, it should not contain more than 0.001% (i.e. after complete evaporation of 100 mL of water, the residue should not exceed 1 mg). X Used for preparation of aqueous oral and topical dosage forms but not for direct parenteral administration. End of Lecture 1 Thank You