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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
- inventive process of finding new medications based on the knowledge of a biological target. - It involves the design of molecules that are complementary in shape and charge to the biomolecular target with which they interact and therefore will bind to it.	Drug Design
Computational Tools for Drug Designing 1 Categories of software	❖ Databases & Draw Tools ❖ Molecular Modeling & Homology Modeling ❖ Binding site prediction & Docking ❖ Ligand design Screening -QSAR ❖ Binding free energy estimation ❖ ADME Toxicity
Types of Drug Design	1. Ligand-based drug design 2. Structure-based drug design
★ relies on the knowledge of the three dimensional structure of the biological target obtained through: - X-ray crystallography - Nuclear Magnetic Resonance (NMR) spectroscopy	Structure-based drug design (Direct)
also known as comparative modeling of protein, refers to constructing an atomic resolution model of the "target" and an experimental three-dimensional structure of a related homologous protein (the "template").	Homology modeling
relies on knowledge of other molecules that bind to the biological target of interest. -used to derive a pharmacophore model that defines the minimum necessary structural characteristics a molecule must possess in order to bind to the target	Ligand-based drug design (Indirect)
It can be defined as an investigation of physical and chemical properties of a drug substance alone and when combined with excipients. • generate information useful to the formulator in developing stable and bioavailable dosage forms that can be mass produced. • designed to deliver all necessary data especially physicochemical, physico- mechanical and bio pharmaceutical properties of drug substances, excipients and packaging materials.	Preformulation studies
- aspects that can be experienced through one’s senses like taste, smell, sight, and touch. - Thus, it includes a recording of the colour, odour, and taste of the drug.	Organoleptic properties of the drug
- It is needed to identify all the solid forms that may exist as a consequence of the synthetic stage such as the presence of polymorphs.	Bulk characters of the drug
1 refers to the outer appearance and internal structure of the drug molecule and can affect its physicochemical properties 2 is the ability of a compound to crystallise in different shapes with different internal structure.	1 Crystallinity 2 Polymorphism
- It is the measure of the tendency to adsorb atmospheric moisture by the drug substance. - It characterizes the drug stability with respect to the environmental	Hygroscopicity
Types of Hygroscopicity 1 a substance which absorb sufficient moisture from the atmosphere to dissolve itself at higher extreme 2 a substance which loses water to form a lower hydrate or become anhydrous at lower level 3 a substance that exist in a dynamic equilibrium with water	. 1 Deliquescent 2 Efflorescent 3 Hygroscopic
The size of the drug particle can influence its dissolution rate, suspendability and other properties.	Fine particle characterization
help you understand the ease with which the drug powder will flow under a set of specific conditions like humidity, pressure and etc	Powder flow properties
(elasticity, plasticity, fragment ability and punch filming propensity) for small quantities of a new drug candidate can be established. This property is used in proper selection of the formulation ingredients.	Compression properties
Methods of Solubility analysis include:	❏ Ionization constant ❏ pH solubility profile ❏ Common ion effect ❏ Thermal effects ❏ Solubilization ❏ Partition coefficient ❏ Dissolution
Is the measurement of the acidity of the compound. Its determination helps in understanding the solubility, protein binding and permeability of the drug substance to characterize its properties like absorption, distribution, metabolism and excretion from the body	Ionization constant
Helps to understand the influence of pH on drug solubility, stability, and absorption	pH solubility profile
Determines the solubility of the drug substance when a solution compound having a common ion with the drug is added to the test solution	Common ion effect
Helps to evaluate the drug solubility with respect to the changes in the drug temperature of the solvent	Thermal effects
Is the measurement of the drug lipophilicity or ability to cross a cell membrane.	Partition coefficient
Is the method of increasing the solubility of the sparingly soluble drug substance by various technique like adding co solvent, changing pH, and temp, adding surfactant, and reducing particle size	Solubilization
Is the process of resolving the drug substance into its individual components and characterizing their properties	Dissolution
These studies include the effect of pH, Ionic strength, Co-solvent, Light, Temperature and Oxygen. Usually these commence with probing experiments to confirm decay at the extremes of pH and temperature e.g., 0.1N HCl (Hydrochloric acid) , water and 0.1N NaOH (Sodium hydroxide) all at 90 deg C.	Solution stability:
The primary objective of this study is investigation and identification of stable storage condition for drug in the solid state and identification of compatible excipients for a formulation to ensure the efficacy, safety, quality of active drug substance and dosage forms, to establish shelf life or expiration period and to support label claims, to gain information about its packaging, assess the condition of the product on storage on prolong period of time, determine compatibility of drug with excipients and other additives and to determine the dosage form in which the drug is most suitable.	Solid state stability