Industrial Pharmacy - B.Pharm 5th Sem Quiz

Questions and Answers

What is the solubility of drugs? Give its significance.

Solubility of drugs refers to the ability of a drug to dissolve in a solvent. It is significant because it affects the drug's absorption, bioavailability, and therapeutic effectiveness.

Define preformulation.

Preformulation is the process of studying the physical and chemical properties of a drug substance to develop a suitable dosage form.

What are hydrates and solvates? Give examples.

Hydrates are compounds that contain water molecules within their structure, while solvates are compounds that contain solvent molecules. For example, crystalline sodium sulfate decahydrate is a hydrate, while a crystal of a drug combined with ethanol can be a solvate.

Define true and pseudo polymorphs.

True polymorphs are different crystalline forms of the same compound, whereas pseudo polymorphs involve solvent molecules in the crystal lattice, such as hydrates. Signup and view all the answers

What are hygroscopic materials? Give examples.

Hygroscopic materials are substances that absorb moisture from the air. Examples include certain salts and sugars. Signup and view all the answers

What are the goals and objectives of preformulation studies?

The goals of preformulation studies include determining the physical and chemical properties of a drug, enhancing formulation stability, and optimizing drug delivery. Signup and view all the answers

What are different analytical methods of particle size and shape determination?

Analytical methods include laser diffraction, microscopy, and dynamic light scattering. Signup and view all the answers

Define partition coefficient along with the Henderson-Hasselbalch equation.

The partition coefficient is the ratio of concentrations of a compound in two immiscible phases. The Henderson-Hasselbalch equation relates pH, pKa, and the ratio of the concentrations of the deprotonated and protonated forms of an acid or base. Signup and view all the answers

Define the term polymorphism.

Polymorphism is the ability of a solid compound to exist in more than one form or crystal structure. Signup and view all the answers

What is Carr's index?

Carr's index is a measure of a powder's flowability, calculated as the difference between the bulk density and the tapped density, divided by the tapped density. Signup and view all the answers

Define oxidation and reduction with examples and their role in preformulation studies.

Oxidation is the loss of electrons, while reduction is the gain of electrons. For example, the oxidation of benzyl alcohol to benzaldehyde is an oxidation reaction. These reactions can affect drug stability. Signup and view all the answers

Define hydrolysis and racemization with examples and their role in preformulation studies.

Hydrolysis is a reaction with water that breaks down compounds, such as the hydrolysis of aspirin to salicylic acid. Racemization is the conversion of an optically active compound into a racemic mixture. Signup and view all the answers

Write the various factors affecting the solubility of drugs.

Factors include temperature, pH, presence of co-solvents, and particle size. Signup and view all the answers

What is BCS classification of drugs?

The Biopharmaceutical Classification System (BCS) classifies drugs based on their solubility and permeability into four categories: Class I (high solubility, high permeability), Class II (low solubility, high permeability), Class III (high solubility, low permeability), and Class IV (low solubility, low permeability). Signup and view all the answers

Define crystal form and amorphous form.

Crystal form refers to a solid's specific geometric arrangement of atoms, while amorphous form lacks this orderly structure. Signup and view all the answers

What are the acceptance criteria for the angle of repose?

Acceptance criteria for the angle of repose usually range from 25 to 45 degrees depending on the material. Signup and view all the answers

Write about Hausner's ratio.

Hausner's ratio is the ratio of tapped density to bulk density, used to evaluate the flow characteristics of powders. Signup and view all the answers

Enlist different solid characterization criteria.

Criteria include particle size, shape, surface area, density, and flow properties. Signup and view all the answers

What are different organoleptic properties of raw materials?

Organoleptic properties include appearance, odor, taste, and texture. Signup and view all the answers

Define angle of repose with its equation.

The angle of repose is the steepest angle of descent of a pile of granular material, calculated as $ an^{-1}rac{h}{r}$, where $h$ is the height and $r$ is the radius of the base. Signup and view all the answers

Describe the importance of partition coefficient in drug design with suitable examples.

The partition coefficient assists in predicting drug absorption and distribution. For example, a drug with a high partition coefficient is likely to be well absorbed. Signup and view all the answers

Write a note on preformulation and explain the goals, objectives, and importance of preformulation studies.

Preformulation studies determine the properties of drug substances to enhance formulation design, ensuring drug stability and efficacy. Signup and view all the answers

Enlist the methods of enhancing the solubility of drugs.

Methods include using co-solvents, salt formation, particle size reduction, and inclusion complexes. Signup and view all the answers

What are different physical parameters of preformulation study?

Physical parameters include particle size, density, solubility, and melting point. Signup and view all the answers

Describe BCS classification with its significance.

BCS classification categorizes drugs based on solubility and permeability, helping to predict their absorption and bioavailability. Signup and view all the answers

Explain solubility and its methods of determination.

Solubility is the ability of a substance to dissolve in a solvent, determined using methods like saturation solubility and equilibrium solubility. Signup and view all the answers

Write a note on angle of repose and different types of densities.

Angle of repose assesses the flowability of powders, while densities include bulk density and tapped density, which assess the compactness of powders. Signup and view all the answers

Write a note on partition coefficient and ionization constant.

The partition coefficient indicates a drug’s distribution across two phases, while the ionization constant (pKa) indicates the pH at which the drug exists in ionized and non-ionized forms. Signup and view all the answers

Write a note on dissolution and angle of repose.

Dissolution is the process of a solute dissolving in a solvent, while angle of repose measures the maximum angle of a pile of granular material before it collapses. Signup and view all the answers

What are the various chemical parameters to consider in preformulation study?

Chemical parameters include pH, stability, reactivity, and solubility of drug substances. Signup and view all the answers

Explain preformulation studies, its objectives, and importance in the pharma industry.

Preformulation studies involve evaluating the physical and chemical properties of drug substances to design effective dosage forms. Signup and view all the answers

Explain the importance of solubility, dissociation constant, and partition coefficient of drug in the development of solid dosage forms.

These factors influence drug absorption, bioavailability, and therapeutic effectiveness in solid dosage forms. Signup and view all the answers

What are various physicochemical properties which are determined prior to formulation?

Properties include solubility, stability, melting point, and polymorphism. Signup and view all the answers

Explain particle size and particle shape in preformulation.

Particle size affects the dissolution rate and bioavailability, while shape influences flowability and packing of solid forms. Signup and view all the answers

Illustrate the various applications of preformulation considerations in the development of pharmaceuticals along with its impact on solubility of dosage form.

Preformulation applications include optimizing drug delivery, improving solubility, and enhancing stability. Signup and view all the answers

Define the term preformulation and explain the parameters to be considered in preformulation studies.

Preformulation refers to the investigation of a drug's physical and chemical properties prior to formulating it. Key parameters include solubility, stability, and compatibility. Signup and view all the answers

Study Notes

Solubility of Drugs

Solubility refers to the ability of a drug to dissolve in a solvent, crucial for effective drug delivery and bioavailability.
Poor solubility can lead to low therapeutic efficacy and variability in drug absorption.

Preformulation

Preformulation is the process of studying the physical and chemical properties of a drug substance to develop a stable and effective dosage form.
It helps identify drug characteristics that influence formulation approaches, stability, and bioavailability.

Hydrates and Solvates

Hydrates are crystals that contain water molecules; e.g., monohydrate forms like theophylline monohydrate.
Solvates are crystals that include solvent molecules other than water; e.g., ethanol solvate of certain drugs.

Polymorphs

True polymorphs are different crystal forms of the same compound, varying in physical properties.
Pseudo polymorphs contain solvent molecules in addition to the drug, impacting solubility and stability.

Hygroscopic Materials

Hygroscopic materials absorb moisture from the environment, which can lead to stability issues in formulations.
Examples include glycerin, sorbitol, and certain salts.

Goals and Objectives of Preformulation Studies

To determine stability and compatibility of drug substances with excipients.
To establish solubility and dissolution characteristics.
To define proper manufacturing and handling conditions.

Analytical Methods of Particle Size & Shape Determination

Techniques include laser diffraction, dynamic light scattering, and microscopy.
Particle size and shape significantly influence the flow characteristics and bioavailability of formulations.

Partition Coefficient

The partition coefficient (P) is the ratio of a compound's concentration in octanol to that in water, indicating lipophilicity and absorption potential.
Handerson-Hasselbalch Equation relates pH, pKa, and ratio of ionized to non-ionized forms.

Polymorphism

Polymorphism refers to the existence of a chemical substance in more than one crystalline form, affecting solubility and stability.

Car's Index

Car's Index is an indicator of powder flowability; a lower index signifies better flow characteristics.

Oxidation and Reduction

Oxidation involves loss of electrons, while reduction involves their gain.
Both processes are critical to drug stability and efficacy during preformulation.

Hydrolysis and Racemization

Hydrolysis is the breakdown of a substance due to reaction with water, often affecting drug stability.
Racemization is the conversion of one enantiomer into another, altering therapeutic activity.

Factors Affecting Solubility

pH, temperature, presence of solvent, drug concentration, and particle size can significantly impact drug solubility.

BCS Classification of Drugs

The Biopharmaceutical Classification System categorizes drugs based on solubility and permeability into four classes, aiding drug development strategies.

Crystal Form & Amorphous Form

Crystal form denotes the organized arrangement of molecules, providing specific physical properties.
Amorphous form lacks a defined structure, generally resulting in higher solubility compared to their crystalline counterparts.

Angle of Repose

The angle of repose is the maximum angle at which a pile of powder remains stable.
Acceptance criteria vary, with typical angles between 25°-30° indicating good flow properties.

Hausner's Ratio

Hausner's ratio is a measure of flowability; values above 1.25 suggest poor flowability due to increased friction between particles.

Solid Characterization Criteria

Criteria include particle size distribution, flowability, compressibility, and moisture content.

Organoleptic Properties

Organoleptic properties describe sensory attributes of raw materials, including taste, smell, and appearance, essential for quality control.

Chemical Parameters in Preformulation

Considerations include stability, compatibility, reactivity, and degradation pathways of drug substances.

Importance of Partition Coefficient

It influences drug absorption and distribution, guiding formulation design and therapeutic effect prediction.

Physicochemical Properties

Key properties include solubility, pKa, molecular weight, and stability that impact formulation viability.

Applications of Preformulation

Preformulation identifies critical parameters that affect drug release, stability, and efficacy, enhancing overall formulation success.

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Description

Test your knowledge on key concepts from Industrial Pharmacy with this quiz specifically designed for B.Pharm 5th semester students. Questions cover topics such as drug solubility, preformulation, and hydrates. Prepare to deepen your understanding of pharmaceutical sciences.