Thermal analysis for preformulation trials new
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This document discusses the use of thermal analysis techniques like differential thermal analysis (DTA), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA) in preformulation studies. These techniques are used to characterize properties of drug substances and excipients like polymorphism, degree of crystallinity, moisture content, and thermal stability. They provide important information on aspects like purity, solid-solid interactions, and decomposition behavior which helps optimize dosage form development. The principles and applications of DTA, DSC, and TGA are explained to analyze various thermal events in materials.
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Friability test ppt
Friable: “ A friable substance is any substance that can be reduced to finer particles by the action of a small pressure or friction, such as rubbing or inadvertently brushing up against the substance”.
Friability test: Defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before & after testing & friability is expressed as a percentage loss on pre-test tablet weight. & Friability test is done to check the ability of the compressed tablet to avoid fracture & breaking during the transport.
This testing involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.
If the average weight of the tablet is 0.65gm or less. Take 10 times of the whole weight i.e., 6.5 gm
2. Carefully deducts the tablets & weight required numbers of tablets.
Initial weight = 6.536gm
3. Set the Time duration for 4min
4. Set number of counts to 100
5. Make sure the drum is cleaned with no contaminates ,
add the initial weighted tables carefully & close the lid
6. Click Start button
Drum diameter : 283 -291mm
Depth: 36-40mm
Inner radius of the curve projection : 75.5mm – 85.5mm
Outer diameter of the central ring : 24.5mm – 25.5mm
Rotation Speed : 25 +/_ 1 cycle
Time Set: 4 min
After 4min automatically it stops ,
7. Take out the tablets & take out the dust from the tablets using brush /crumps
8. Take the After weight of the tablets
Total weight of after rotation= 6.443gm
Interpretation :
Value of friability should not be more than 1% for most of tablets.
If the value of friability for the first is greater than 1%, then repeat the test twice & mean of three values is taken.
If the mean value of three tests is less than 1% tablets passes the friability test,
otherwise tablet fails the test.
If the tablets are broken , chipped or cracked during the test, the tablets fails the friability test.
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The document summarizes film coating techniques and problems. It discusses the purposes of film coating including masking taste, controlling drug release, and protecting ingredients. It then describes the mechanisms of film formation for aqueous and non-aqueous coatings. Key coating process parameters like spray pressure, temperature and pan speed are outlined. Common materials used include film formers like hydroxypropyl methylcellulose, plasticizers, pigments and solvents. Finally, potential defects in film coating like picking or mottling are briefly mentioned.
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The document discusses the objectives and guidelines of the International Council for Harmonization (ICH) for stability testing of pharmaceutical products. It provides an overview of the key ICH guidelines for stability testing (Q1A-Q1F) and describes the principles of stability testing including establishing re-test periods and shelf lives. It also discusses the different types of stability testing, protocols, study designs like bracketing and matrixing, and key parameters for evaluation.
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This document discusses different types of tablets and the tablet manufacturing process. It begins by defining what a tablet is and listing some key advantages such as precise dosing, low cost, and stability. It then describes different types of tablets including compressed, coated, chewable, and those for different routes of administration. The document outlines common excipients used in tablets and their functions. It explains the importance of granulation and describes different granulation methods including dry, wet, and direct compression. The wet granulation process is outlined in detail including mixing, granulation, and drying steps.
Table quality control test
I. The document discusses quality control tests that are performed on tablets to ensure they meet standards for safety, efficacy and other quality parameters. It describes tests like hardness testing, friability testing, thickness measurement, disintegration testing and dissolution testing.
II. Official tests discussed include weight variation testing, disintegration testing, dissolution testing and drug content uniformity. Unofficial tests include thickness measurement, hardness testing and friability testing.
III. The document provides details on the procedures, equipment and apparatus used for these various quality control tests performed on tablets.
Formulation of parenteral products
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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This document provides an overview of thermal methods of analysis, including thermogravimetric analysis (TGA), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). It describes the basic principles, instrumentation, and applications of each technique. TGA measures changes in a sample's mass with temperature. DTA measures the temperature difference between a sample and reference material as they are heated. DSC measures the heat flow into or out of a sample during heating or cooling. All three techniques are used to study physical and chemical changes that occur in materials with temperature changes.
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The document provides an overview of stability testing during product development. It discusses the importance of stability testing to ensure product quality and safety over the shelf life. Various methods of stability testing are described, including real-time, accelerated, and retained sample testing. Guidelines for stability testing from ICH, WHO, and other agencies are also covered. The document outlines the key aspects of a stability testing protocol, including batches, containers, storage conditions, sampling plan, test parameters, and acceptance criteria. It provides details on conducting, recording, and presenting stability testing data.
Friability test ppt
Friable: “ A friable substance is any substance that can be reduced to finer particles by the action of a small pressure or friction, such as rubbing or inadvertently brushing up against the substance”.
Friability test: Defined as the % of weight loss by tablets due to mechanical action during the test. Tablets are weighing before & after testing & friability is expressed as a percentage loss on pre-test tablet weight. & Friability test is done to check the ability of the compressed tablet to avoid fracture & breaking during the transport.
This testing involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.
If the average weight of the tablet is 0.65gm or less. Take 10 times of the whole weight i.e., 6.5 gm
2. Carefully deducts the tablets & weight required numbers of tablets.
Initial weight = 6.536gm
3. Set the Time duration for 4min
4. Set number of counts to 100
5. Make sure the drum is cleaned with no contaminates ,
add the initial weighted tables carefully & close the lid
6. Click Start button
Drum diameter : 283 -291mm
Depth: 36-40mm
Inner radius of the curve projection : 75.5mm – 85.5mm
Outer diameter of the central ring : 24.5mm – 25.5mm
Rotation Speed : 25 +/_ 1 cycle
Time Set: 4 min
After 4min automatically it stops ,
7. Take out the tablets & take out the dust from the tablets using brush /crumps
8. Take the After weight of the tablets
Total weight of after rotation= 6.443gm
Interpretation :
Value of friability should not be more than 1% for most of tablets.
If the value of friability for the first is greater than 1%, then repeat the test twice & mean of three values is taken.
If the mean value of three tests is less than 1% tablets passes the friability test,
otherwise tablet fails the test.
If the tablets are broken , chipped or cracked during the test, the tablets fails the friability test.
By ArcImBioCLinica (AIBC)
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In DSC the heat flow is measured and plotted against temperature of furnace or time to get a thermo gram. This is the basis of Differential Scanning Calorimetry (DSC).
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This document provides an overview of thermogravimetric analysis (TGA). TGA measures how the mass of a sample changes as it is heated. Key points:
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- Results are displayed as thermogravimetric (TG) curves plotting mass change vs. temperature or time. Curves reveal information about decomposition temperatures, reactions, and composition.
- Instrumentation includes the microbalance, furnace, temperature controller, and data recorder. Microbalances must precisely and rapidly detect small mass changes under varying conditions.
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This document discusses different thermal analysis techniques including thermo gravimetric analysis (TGA), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). TGA measures mass changes as a function of temperature. DTA measures the temperature difference between a sample and reference as they are heated. DSC directly measures heat flows into or out of a sample during transitions. The techniques are used to study physical and chemical transitions in materials and have applications in fields like polymers, food, pharmaceuticals, and ceramics for analyzing composition, stability, phase transitions, and melting/boiling points.
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Differential thermal analysis (DTA) is a thermal analysis technique that measures the temperature difference between a sample and an inert reference material as they are heated or cooled. DTA can detect physical or chemical changes in a sample as they occur, such as fusion, crystallization, oxidation, or decomposition. Changes are detected based on the temperature difference that develops between the sample and reference material. DTA provides a characteristic "fingerprint" curve for a sample that can be used to identify materials. Common applications of DTA include quantitative identification and purity assessment of materials.
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- 1. THERMAL ANALYSIS FOR PREFORMULATION TRIALS LIAKAT CHOWDHURY M.PHARM(1ST YEAR) DEPARTMENT OF PHARMACEUTICS GUPTA COLLEGE OF TECHNOLOGICAL SCIENCES ASANSOL
- 2. PREFORMULATION Preformulation is the first step of rational development of a dosage form of a drug substance It include investigation of physico -chemical property of new drug substance that could affect drug performance and development of efficacious dosage form It relates the pharmaceutical & analytical investigation to that proceed & support to develop a dosage form
- 3. GOALS OF PREFORMULATION To establish necessary physico -chemical parameters of new drug substance. To determine the kinetic rate profile. To establish physical characteristics of drug substance. To establish compatibility with common excipients.
- 4. Thermal Analysis Techniques IUPAC definition - a group of techniques in which a physical property is measured as a function of temperature, while the sample is subjected to a controlled temperature programme (heating, cooling or isothermal). A range of techniques e.g.: • Differential Thermal Analysis (DTA) – temperature • Differential Scanning Calorimetry (DSC) – energy • Thermogravimetric Analysis (TGA) – mass • Thermomechanical Analysis (TMA) – dimensions • Dielectric Analysis (DEA) – dielectric/electric properties
- 5. Basic Principles of Thermal Analysis Modern instrumentation used for thermal analysis usually consists of the following parts: sample holder/compartment for the sample sensors to detect/measure a property of the sample and the temperature an enclosure within which the experimental parameters (temperature, speed, environment) may be controlled a computer to control data collection and processing temperature sample PC control (furnace) sensors
- 6. ROLE OF THERMAL ANALYTICAL METHODS IN PREFORMULATION STUDY These are unique methods in the field of polymer analysis & of high value for a solid state analysis. They finds wide application in Detection of impurity Determination of moisture content in any drug substance or any excipient Study of polymorphism Characterization of hydrates & solvates Degree of Crystallinity Study of phase diagram Drug excipient compatibility study Study of complexation
- 7. Differential thermal analysis (DTA) DTA involves heating or cooling a test sample and an inert reference under identical conditions, while recording any temperature difference between the sample and reference. This differential temperature is then plotted against time, or against temperature. Changes in the sample which lead to the absorption or evolution of heat can be detected relative to the inert reference.
- 8. Differential Scanning Calorimetry (DSC) is one of the most frequently used techniques in the field of thermal characterization of solids and liquids Pharmaceutically Relevant Information Derived from DSC Analysis - melting/crystallization behavior solid-solid reactions polymorphism degree of crystallinity glass transitions cross-linking reactions oxidative stability decomposition behavior purity determination specific heat
- 9. Differential Scanning Calorimetry – Principle of Operation a sample is placed inside a crucible which is then placed inside the measurement cell (furnace) of the DSC system along with a reference pan which is normally empty (inert gas may be used). By applying a controlled temperature program (isothermal, heating or cooling at constant rates), phase changes can be characterized and/or the specific heat of a material can be determined. Heat flow quantities are calculated based on calibrated heat flow characteristics of the cell.
- 10. Thermogravimetric Analysis (TGA) A technique measuring the balance variation in mass of a sample undergoing temperature scanning in a sample controlled atmosphere. Thermobalance allows for monitoring sample weight as a function of temperature. The sample hangs from the balance inside the furnace purge gas furnace and the balance is thermally isolated from the furnace.
- 11. Summary of Pharmaceutically Relevant Information Derived from TGA Analysis Moisture and Volatiles Content of Materials Composition of Multicomponent Systems Thermal Stability of Materials Oxidative Stability of Materials Estimated Lifetime of a Product Decomposition Kinetics of Materials The Effect of Reactive or Corrosive Atmospheres on Materials Quantitate the presence of solvated species within a bulk drug sample.
- 12. Limitation of Thermal Analysis Low sensitivity of transitions involving small energies. Impurity consisting of molecules of same size, shape , character as those of the major component are not detected by DSC. TGA used to study hudrates and moisture study are not always reliable. Thermal analysis are affected by number of factors.
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