Stability of Drugs and Dosage Forms

JNTUH M.Pharm 2017-2018 (R17) Detailed Syllabus Stability of Drugs and Dosage Forms
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It fulfills one elective. Take the course as is or as part of the certificate. Scientists who plan to expand their understanding of solid dosage forms should take this course. Refund Policy. No refunds will be provided after that date. This short course provides the learner with current, research-based information covering but not limited to crystalline and amorphous properties of molecular solids, fundamental properties of powders, and the relationships between solubility, permeability, partitioning, diffusion rates of dissolution and release mechanisms.

Upon completion of this course, the learner should be able to:. Scientists who are working on creating formulations for small molecule drugs in all stages of development. Monday, May 11, am. Introduction: Overview of Solid State Properties of Drug This session will give a brief overview of important solid state properties that can change the bioavailability, manufacturability, and stability of solid dosage forms.

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Clin Gastroenterol H. WordPress Shortcode. To provide better storage condition. Submit Search. Development of forced degradation and stability indicating studies of drugs - a review.

Selecting Appropriate Solid Forms: Crystalline and Amorphous States This session will define and highlight the important pharmaceutical properties of crystal polymorphs and amorphous forms of drugs. This session will describe methods to measure the particle size of drugs, important issues related to the effect of particle size on pharmaceutical processing, and the effect of size on the bioavailability of drugs.

Key points

This session will highlight the effect of shape on the formulation of solid dosage forms, methods to determine the shape of particles, and models to predict the influence of particle shape on formulation. This session will identify those processing and environmental factors that determine the solid state and chemical stability of drugs. Following up on the issues identified with solid state stability in the previous session this session will concentrate on the effect of moisture, from processing and the environment, on the stability of drugs, in particular changes in the amorphous and polymorphic state of drugs.

This session will define mixing a quality and uniformity. In particular sampling form mixtures and methods to measure content uniformity will be discussed.

This session will define dissolution and discuss models to describe the dissolution of drugs. It will also discuss factors that can change the dissolution of solids. Assessing Solubility and Making Appropriate Choices This session will look at structure solubility relationships for drug molecules. Current methods to assess bioavailability, such as BCS, will be discussed and examples shown on these methods can be used in the formulation of drug products.

Table of contents

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and This book discusses the stability of these dosage forms with prefor. A thorough knowledge of the chemical and physical stability of drugs and dosage forms is critical in the development and evaluation ofpharmaceuticals.

Several systems used to prepare controlled release dosage forms will be discussed. The advantages and disadvantages of the systems will be demonstrated by a series of examples. Both session on this day will deal with processing, evaluation and manufacturing of tablets and capsules.

Issues such as powder mixing, compression, excipient choice and others will be discussed. In the first part a brief overview of current methods to generate nanoparticles for drug delivery will be given. The second part will discuss issues and concerns related to combining two or more drugs in the same tablet or capsule. Melgardt M. Daniel P.

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Actions Shares. Embeds 0 No embeds. No notes for slide. Stability of drugs 1. By Dr. Stability of drugs Cont. Instability may causeUndesired change in performance; i. Factors affecting Drug Stability Cont. Light: affect stability through its energy or thermal effect.

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Concentration: rate of drug degradation is constant for the solutions of the same drug with different conc. Drug incompatibility: reactions between components of dosage form or between components and cover of container. Physical stability Physical stability implies that: The formulation is totally unchanged throughout its shelf life and has not suffered any changes by way of appearance, organoleptic properties, hardness, brittleness, particle size.

What are Complex Drug Products? | Particle Sciences

It is significant as it affects: pharmaceutical elegance drug content uniformity drug release rate. Crystal formation :.

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Loss of volatile subs. Loss of water: in Saturated sol. Physical stability Cont. Formulation Likely physical instability problems Effects Parenteral solutions 1. Discoloration due to photo chemical reaction or oxidation 2. Presence of precipitate due to interaction with container or stopper 3. Formulation Likely physical instability problems Effects Suspensions 1- settling 2- caking 3- crystal growth 1-Loss of drug content uniformity in different doses from the bottle 2- loss of elegance.

Stability of Drugs and Dosage Forms

Changes in: a Particle size b Consistency 2. Caking or coalescence 3. Bleeding 1-Loss of drug content uniformity 2- loss of elegance 3-change in drug release rate.