1 - Introduction to Dosage Forms and Delivery System.pdf

 Learning objectives At the end of the lecture session, the students shall be able to: Define Drugs, Dosage Forms, and Drug Delivery System Explain the importance of Dosage forms List examples of Pharmaceutical Excipients Name the different routes of administration Discuss th...

 Learning objectives At the end of the lecture session, the students shall be able to: Define Drugs, Dosage Forms, and Drug Delivery System Explain the importance of Dosage forms List examples of Pharmaceutical Excipients Name the different routes of administration Discuss the drug development process PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  cinchona bark -2 antimalarial drugs were isolated DRUG 1. quinine 2. cinchonine Definition According to RA 3720: Food, Drug, and Cosmetics Act of 1963 Articles recognized in the official United States Pharmacopoeia, recognized in the official United States Pharmacopeia official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; Article intended forpractice theor use science ofin the diagnosis, cure, defined by WHO, what medicine is - preparation mitigation, intended treatment, for the use in the or prevention diagnosis, cure, mitigation, of disease treatment, or prevention of disease in man, or other animals; *we can say that all medicines are drug but not the other way around Articles (other than food) intended to affect the structureintended or any to affect the function structure or anyof theof body function the body of human or other allergy animals; and Articles intended for use as a component of any articles specified in any of the previously mentioned definitions. we can combined 2 drugs in one preparation PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG exclusively physicians- first ever version of the USP and then na discover importance ni PHARMACY he created a project/initiate to make all municipalities to have USP/NF United States Pharmacopoeia-National Formulary convention where they’ll meet and combine all their pharmacopeias to create United States Pharmacopeia Pharmacopeia-National = pharmakon (drug); poein (make) Formulary. national pharmacopeia -any formula/standards required to make or prepare to be recognized as a drug Pharmacopoeia -used as early as 1580 in Italy = pharmakon (drug); poein (make). -father of USP -precursor of the first ever USP Established in 1820 due to several key reasons: -272 pages- almost 563 drugs listed US Standardization of medicine ifachieve you achieve standards, you can a specific set of quality Massachusetts Lyman Spalding Public Health and Safety Pharmacopeia Professionalization of Pharmacy and Medicine National Formulary National Formulary – compendium of standards for pharmaceutical ingredients, excipients and dosage forms. 1852- American PhA was established ; responsible in updating the USP requirement: established therapeutic merit National Formulary of Unofficial Preparations (1888) first name Title was changed to National Formulary in 1906 when the Pure Food and Drug Act was signed by Theodore Roosevelt and considered a national compendia. In 1975, the USP Convention Inc. bought NF, unifying the two compendia. latest: USP 42nd, NF 37th Ed PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM First US Pharmacopeial Convention, Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. 1820.  DRUG USP/NF Monograph MONOGRAPH A factual, scientific document that provides the standards for the identity, strength, purity, and consistency of a specific drug substance, dosage form, or excipient. Parts of a Monograph: Identification test to confirm its identity/presence Assay methods/procedure to determine its potency/strength Purity determine any impurities/contaminants Quality assess the physicochemical properties of substance ex. ph, dissolution, stability Packaging and Storage temp. and type of container Labeling important part PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DOSAGE FORMS DEFINITION Means of administering drugs as formulated preparations. 2 composition/ components: Combination of a drug entity (active pharmaceutical ingredient) and drug additives. Pharmaceutical Preparations PHARMACEUTICAL PREPARATIONS set of procedures/guidelines Process of making a drug entity ready for use. Drug Product DRUG PRODUCT Finished dosage form that contains a drug entity, generally, but not necessarily, in association with inactive ingredients. drug additives PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DOSAGE FORMS AMOXICILLIN DEFINITION B-lactam group Means of administering drugs as formulated preparations. Combination of a drug entity drug entity (active pharmaceutical (active pharmaceutical ingredient) and drug additives. PARACETAMOL ingredient) and drug additives. Active Pharmaceutical Active Pharmaceutical Ingredient Ingredient same definition to drug Any chemical entity that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body CAFFEINE or 1, 3, 7- trimethyl xanthine of man or other animals structure: xanthine 3 methyl groups PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DOSAGE FORMS DEFINITION Means of administering drugs as formulated preparations. Combination of a drug entity drug entity (active pharmaceutical (active pharmaceutical ingredient) and drug additives. ingredient) and drug additives. Excipients (Drug additives) Excipients (Drug additives) Any component other than the active pharmaceutical ingredient in a dosage form. also called Inactive ingredient. Provides the drug or active therapeutic agent in a form suitable for administration. uses: emulsifying agent stablizer preservatives PH-PSC 212 flavorant INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  Active Pharmaceutical Ingredient (API)- prone to oxidation DOSAGE FORMS need additives/excepients that are anti-oxidants DEFINITION Importance of Dosage Forms Protect the drug entity from the destructive influences of atmospheric oxygen or humidity and gastric acid after oral administration. film coated Conceal the unpleasant taste or odor of a drug substance. flavorant/coated tablet Provide an ideal preparation to transport a drug entity into the body. solid/oral Provide rate-controlled drug action. solid dosage form controlled-release - consistent rate of absorption delayed-release- stay for a while in the stomach PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG DELIVERY SYSTEM DEFINITION Method designed to transport a pharmaceutical compound into the body in a controlled and efficient manner to achieve its utilized skin desired therapeutic effect. both drugs and dosage form PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG DELIVERY SYSTEM ROUTE OF ADMINISTRATION INTRAvascular INTRAVASCULAR EXTRAvascular EXTRAVASCULAR Intravenous (IV) – bolus or infusion. Oral Others administer bulk constant Intraarterial (IA) one time big time administration for a Buccal Inhalation long period Topical Intracardiac (IC) heart chamber Sublingual under the tongue Transdermal Rectal Intranasal Vaginal Parenteral Urethral SC/SQ subcutaneous Otic IM intramuscular ID intradermal IP intraperitoneal IO intraocular PH-PSC 212 IT intrathecal - spinal cord INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  How are drugs DISCOVERED AND DEVELOPED PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT 1st step PROCESS 10-15 years to develop a new drug 2nd 3rd FDA- regulatory 5th 4th human volunteers 6th 7th post-marketing surveillance PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS New Chemical NEW CHEMICAL ENTITY Entity “A drug that contains no active moiety that has been approved by FDA in any other New Drug Application submitted under the FDC Act.” insulin & hyperin Papaver somniferum bovine- cow Possible sources: -drug morphine porcine- pig Plant SOURCES PLANT sources AnimalSOURCES ANIMAL sources 270, 000 plants reservoir MarineSOURCES MARINE source DNA polymerase inhibitor caribbean sponge -cytarabine PH-PSC 212 -vidarabine INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG DEVELOPMENT PROCESS New Chemical Entity “A drug that contains no active moiety that has been approved by FDA in any other New Drug Application submitted under the FDC Act.” gene therapy Possible sources: GeneticSOURCES GENETIC sources lower organism Recombinant DNA (bacteria) higher organism (human) human insulin first recom DNA same principles -alter the DNA sequence monoclonal antibodies PH-PSC 212 -both use higher organisms and diagnostic agent INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Goal Drug A theoretical or ideal drug that meets all the desired criteria for treating a specific condition or disease. Characteristics of a Goal Drug: Specified desired effect Administered by the most desired route oral administration Minimal dosage and dosing frequency Optimal onset and Duration of action No side effect Eliminated efficiently, completely, and without residual effect. PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Methods of Drug Discovery Random orUNTARGETED RANDOM OR Untargeted Screening SCREENING Traditional approach shot gun testing Testing large numbers of synthetic organic compounds or substances of natural origin for biologic activity without specific knowledge of its mechanism of action or precise biological target it might affect. Downside: Some compounds can be overlooked. result can be used in the targeted screening PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Methods of Drug Discovery Bioassays BIOASSAYS Used to differentiate the effect and potency of the test agent. Can be performed initially using cell cultures. Text High-throughput HIGH-THROUGHPUT screening SCREENING Examines 15,000 chemical compounds a week using 10 to 20 biologic assays. untargeted screening -not achievable by humans Molecular Sds MOLECULARModification MODIFICATION -performed using software, library of chem compounds Chemical alteration of a known and previously characterized organic compound (lead compound). inactive form to active form -creation of semisynthetic organic compounds, Mechanism-based drug design utilized natural chemicals to produce chem compounds PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Methods of Drug Discovery Molecular Modification MOLECULAR MODIFICATION Mechanism-based drug design Enalaprilat ENALAPRILAT used for hypertension Active metabolite of Enalapril. ACE inhibitor. angiotensin converting enzyme PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG DEVELOPMENT PROCESS Prodrugs PRODRUGS Describe a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound. prodrug active form -undergo first-pass effect -liquid PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Prodrugs Describe a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound. Designed preferably for: Solubility it should have aqueous solubility Absorption balance hydro and lipophilic Biostability valacyclovir (55%) prodrug of acyclovir 10%(antiviral) Prolonged-release PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Pharmacology Pharmacodynamic and pharmacokinetic profile Biochemical process higher quantity in the systemic circulation higher chance to saturate receptors increases pharmacologic effect structure activity relationship or SAR -diff chem structure but bind at the same receptor site first administer = bind first affinity if sabay nag bind Quantity of drug molecules available for interaction. higher affinity- bind first even if first administer PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Pharmacology Determining the pharmacologic profile: Determine selectivity for various receptors and activity against select enzyme systems. Determine cell function Use of isolated animal tissues Whole-animal studies Animal models of human disease PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Pharmacology Determining the pharmacologic profile: Animal models of human disease Mouse Rat Dog Guinea Pig Rabbit PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Drug Metabolism – animal studies to establish the drug’s ADME: Extent and rate of drug absorption from various routes of administration. Rate of distribution through the body. Rate and mechanism of drug metabolism Rate and route of elimination PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Drug Metabolism PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical Studies Biologic Characterization Toxicity – adverse or undesired effects of drugs. Types of Toxicity Studies Acute or short term – effects of a test compound after a day. Subacute or sub-chronic – after a minimum of 2 weeks. Chronic – after 90 to 180 days. Carcinogenicity Studies – long term studies (18-24 months); component of chronic toxicity studies; determination of tumor formation. Reproductive Studies – determine any effects on mammalian reproduction (teratogenicity). Genotoxicity or Mutagenicity Studies – determines if the compound affects gene mutation. PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical studies Pre-formulation PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical studies Pre-formulation Studies aimed at collecting basic information on the _______ and __________ characteristics of the drug substance to be prepared into pharmaceutical dosage forms. Goal: To produce an optimum drug delivery system Physical and Chemical characteristics: Solubility Dissolution Rate Stability Partition Coefficient Physical Form PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-clinical studies Pre-formulation Report Background Organoleptic Properties Compound Color Chemical Name Odor Chemical Structure Taste Appearance Solvents for recrystallization Purity Microscopic Examination Therapeutic category Particle size and range Anticipated dose Crystal structure and shape Polymorphism PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  DRUG DEVELOPMENT PROCESS Pre-clinical studies Pre-formulation Report Physical properties Organoleptic Properties Density Color Flow Properties Odor Compressibility Taste Appearance Microscopic Examination Particle size and range Crystal structure and shape Hygroscopicity PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Excipients Added to a formulation to provide functional properties to the drug and dosage form Improve compressibility of the active drug Stabilize the drug from degradation Decrease gastric irritation Control rate of absorption Increase bioavailability PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Common Excipients Acidifying agent – Citric acid, Acetic acid Alkalinizing Agent – NH3 solution, DEA Adsorbent – Activated charcoal, Powdered cellulose Aerosol – CO2, Dichlorotetrafluoromethane Nitrogen Antifungal/Antimicrobial Preservative – parabens, benzalkonium chloride PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Common Excipients Chelating agent – EDTA Colorant – FDC (FDC Red 40, FDC Yellow 6, FDC Yellow 5, FDC Blue 2) Clarifying agent – Talc Emulsifying agent – acacia, cetyl alcohol Flavorant Humectant - Glycerin PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Common Excipients Ointment base – hydrophilic or hydrophobic Plasticizer Solvent – water, alcohol, COCOPESE Stiffening Agent – White and Yellow Wax Suppository Base – Cocoa butter, PEG Surfactant – SLS, Tweens, Spans Suspending Agent –Bentonite, CMC, HPMC, Carbomer PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Common Excipients Sweetener – Aspartame, Mannitol, Glycerin, Sorbitol Diluent – Lactose, Starch, MCC Disintegrant – Starch, MCC Lubricant – magnesium stearate, talc, stearic acid Granulating agent – PVP, Methylcellulose Coating agent – HPMC, Cellulose acetate phthalate Suspending agent – Tragacanth, Xanthan gum PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Common Excipients Sweetener – Aspartame, Mannitol, Glycerin, Sorbitol Diluent – Lactose, Starch, MCC Disintegrant – Starch, MCC Lubricant – magnesium stearate, talc, stearic acid Granulating agent – PVP, Methylcellulose Coating agent – HPMC, Cellulose acetate phthalate Suspending agent – Tragacanth, Xanthan gum PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI. DRUG DEVELOPMENT PROCESS Pre-formulation Drug-Excipient Compatibility Determine the stability of the drug in the presence of the excipient or a combination of excipients Consider 2 or more excipients from each class Drug-excipient ratio must be consistent with the ratio most likely to be encountered in the final formula and will depend on the nature, size and potency of the excipient Cartensen recommended drug-excipient ratios: 1:1 for excipients used in relatively large amount 20:1 for excipients used in small amount PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.  END OF DISCUSSION. PH-PSC 212 INTRODUCTION TO DOSAGE FORMS AND DRUG DELIVERY SYSTEM Note: For PH-PSC 212 FS AY 24-25 students only. Approval of the faculty-in-charge must be sought before any citations or adoptions. Copyright principle for this idea creation/handout operates at DLSMHSI.