Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form PDF

Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form PHARMACEUTICS Drug This is the pharmacologically active ingredient in a medicine. Medicine /Dosage form Medicines are mean of administering drugs to the body in a safe, efficient, repr...

Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form PHARMACEUTICS Drug This is the pharmacologically active ingredient in a medicine. Medicine /Dosage form Medicines are mean of administering drugs to the body in a safe, efficient, reproducible and convenient manner. These can also be termed as drug delivery systems. Pharmaceutics “Pharmaceutics is concerned with the scientific and technological aspects of drug/dosage form design and manufacture.” The word pharmaceutics is used to cover many subject areas that are all associated with the steps to which a drug is subjected towards the end of development. Simply we can say “Pharmaceutics converts a drug into a medicine” The term pharmaceutics does not include the stages that are following its discovery and its synthesis, isolation and purification and studies for determination of its pharmacological and toxicological effects. Pharmaceutics is a diverse subject and encompasses:  Understanding of the basic physical chemistry necessary to design the efficient dosage form (physical pharmacy)  Understanding the relevant body systems to and how drug arrives there following drug administration (Biopharmaceutics).  The design and formulation of medicine (dosage form design).  The manufacture of these medicines on both small (compounding) and large (pharmaceutical technology) scale.  The avoidance and elimination of microorganisms in medicines (pharmaceutical microbiology) DOSAGE FORM “Dosage forms are means of administering drugs to the body in a safe, efficient, reproducible and convenient manner” Drugs are rarely administered as pure chemical alone and are almost always administered as formulated preparations or medicines. These preparations vary from simple solution to complex drug delivery system through the use of appropriate additives or excepients in the formulations. These excepients provide varied and specialized pharmaceutical functions. The excepients play various function including solubilization, suspension, thickening, preservation, emulsification, modified dissolution, improved compactability and flavoring of various medicines and dosage forms. Page 1 Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form NEED FOR DOSAGE FORM In addition to some basic uses of dosage form it is required for the following reasons 1. Protection of drug from the atmospheric degradation by oxygen and humidity 2. Protection from the destruction of drug by the gastric acid after oral administration (enteric coated tablet). 3. To conceal the bitter, salty or offensive taste or odor of a drug substance (capsule, coated tablet, flavored syrup) 4. To provide liquid preparations of substances those are either insoluble or unstable in the desired vehicle (suspensions) 5. To provide clear liquid dosage form of substances (syrup solutions) 6. To provide rate controlled action (controlled release tablet, capsule and suspensions) 7. To provide optimal drug action from topical administration sites (ointments, creams, transdermal patches ophthalmic, ear and nasal preparations) 8. To provide insertion into one of the body orifice (rectal, vaginal suppositories) 9. To provide the drug directly into the blood stream or into the body tissue (injection) 10. To provide for optimal drug action through inhalation therapy (inhalants or inhalation aerosol) GENERAL COSIDERATIONS IN DESIGNING A DOSAGE FORM Objective of dosage form The principle objective of dosage form is to achieve a predictable therapeutic response to a drug included in formulation, which is capable of large-scale manufacture with reproducible product quality. The features in a dosage form A quality product can be achieved by introducing numerous features in the preparation.  The chemical and physical stability  Suitable preservation against microbial contamination  Uniformity of dose  Acceptability both by patient and prescriber  Suitable packaging and labeling Considerations in dosage form design To achieve the above mentioned objective successfully a drug substance can be formulated into dosage form by considering the factors  Biopharmaceutical considerations, including factors affecting the absorption of the drug substance from different administration routes  Drug factors including the physicochemical properties of the drug substance, particle size ad surface area, solubility, dissolution, crystal properties, organoleptic properties etc. Page 2 Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form  Therapeutic considerations, including consideration of the clinical indication to be treated and patient factors such as age. DOSAGE FORMS Following is list of some commonly used Dosage Forms  Aerosoles  Applications  Capsules  Collodions  Creams  Dusting powder  Ear drop elixirs  Emulsions  Enemas  Eye drops  Gargles  Gels  Granules  Implant  Inhalations  Injections  Insufflations  Irrigations  Lictuses  Liniments  Lotions  Lozenges  Mixtures  Mouthwashes  Nasal drops and sprays  Ointments  Paints  Pastes  Pastilles  Pessaries  Pills  Powders  Suppositories  Suspensions  Syrups Page 3 Dosage Form Science-I (Fall 2023) Introduction to Pharmaceutics/ Dosage form  Tablets  Transdermal delivery systems DOSAGE FORM AVAILABLE FOR DIFFERENT ROUTES OF ADMINISTRATION Administration Dosage form route Oral Solution, syrups, suspension, emulsion, gels, powder, granules, capsule, tablets Rectal Suppositories, ointment, creams, powder, solutions Topical Ointment Cream, Pastes, Lotion, Gel, Solutions, Topical Aerosols, Transdermal Patches Parenteral Injections, solution, suspension, emulsion), implants, irrigation and dialysis solution Respiratory Injections, solution, suspension, emulsion), implants, irrigation and dialysis solution Nasal Aerosol (solution, suspensions, emulsion, powder form), inhalations, sprays, gases Eye Solution, Ointment Creams Ear Solution, Suspension, Ointment, Creams Page 4