This document summarizes a study that formulated and evaluated fast dissolving tablets containing the drug fosinopril. Nine formulations of fosinopril tablets were prepared using different concentrations of superdisintegrants like croscarmellose sodium (CCS), crospovidone (CP), and sodium starch glycolate (SSG). The tablets were evaluated for pre-compression and post-compression parameters. In vitro drug release studies found that formulation F7, containing 20% SSG, showed maximum drug release within 30 minutes. Fourier transform infrared spectroscopy confirmed no drug-excipient interactions. The study developed fast dissolving fosinopril tablets using superdisintegrants and evaluated their characteristics.
The document discusses the evaluation and testing of tablets. It describes non-official tests like general appearance, organoleptic properties, size and shape, hardness, and friability. It also describes official tests like weight variation, content uniformity, dissolution, and disintegration. It discusses different types of tablets like compressed and molded tablets. It provides details on evaluating the appearance, hardness, friability and other properties of tablets and describes tests like weight variation, content uniformity, and dissolution used to ensure tablets meet specifications.
This document evaluates different parameters for testing tablets, including size, shape, hardness, friability, weight variation, disintegration, and dissolution. It discusses how these parameters are measured using various instruments and test methods. The key parameters are evaluated to ensure tablets meet specifications according to pharmacopoeia standards like the USP and IP.
This document provides an introduction and overview of tablets, including their definition, general properties, advantages, disadvantages, and classification. It discusses the main types of tablets based on use, structure, and action. The document also covers tablet design and formulation, describing the various excipients used (diluents, binders, disintegrants, lubricants) and their functions. It provides examples of different tablet types and dosage forms, such as chewable, dispersible, effervescent, and sublingual tablets.
This document provides information on quality management and quality control processes for pharmaceutical products. It discusses key concepts like quality assurance, quality control, quality management systems. It also summarizes the differences between quality assurance and quality control. The document then describes various quality control tests conducted on tablets and capsules, including tests of general appearance, hardness, friability, disintegration. It provides details on the purpose, procedures, and acceptance limits for these quality control tests.
COMPARATIVE EVALUATION OF DIFFERENT PARACETAMOL BRANDSShikha Popali
THE PARACETAMOL TABLETS IS COMMONLY TAKEN AND PRESCRIBED FOR FEVER , SO HERE WE HAVE MADE PRACTICAL IS IT TRUE EVALUATION LABEL AND WHICH BRAND IS MORE SAFE.
The document outlines the evaluation of various solid, semi-solid, and liquid dosage forms. For solid dosage forms like tablets, important tests include general appearance, weight variation, content uniformity, hardness, friability, disintegration, and dissolution. These tests are conducted to ensure quality, consistency in drug content between tablets, and that the drug will release and dissolve properly. Similar tests are described for other dosage forms like capsules, granules, powders, ointments, creams, suppositories, syrups, suspensions, emulsions, and novel delivery systems. The goal of evaluation is to quantify properties and assess interactions that impact drug stability and bioavailability.
TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.Amruta Sonawane
This document summarizes key tests performed on pharmaceutical formulations, including content uniformity, hardness, and dissolution. Content uniformity testing ensures each tablet contains the intended amount of active drug with little variation between tablets. Hardness testing measures a tablet's crushing strength, with limits varying based on the type of tablet. Dissolution testing predicts in vivo drug release profiles using basket or paddle apparatus under set conditions to simulate gastrointestinal fluids. These tests help ensure consistent dosing, sufficient strength, and controlled drug release.
The document discusses the evaluation and testing of tablets. It describes non-official tests like general appearance, organoleptic properties, size and shape, hardness, and friability. It also describes official tests like weight variation, content uniformity, dissolution, and disintegration. It discusses different types of tablets like compressed and molded tablets. It provides details on evaluating the appearance, hardness, friability and other properties of tablets and describes tests like weight variation, content uniformity, and dissolution used to ensure tablets meet specifications.
This document evaluates different parameters for testing tablets, including size, shape, hardness, friability, weight variation, disintegration, and dissolution. It discusses how these parameters are measured using various instruments and test methods. The key parameters are evaluated to ensure tablets meet specifications according to pharmacopoeia standards like the USP and IP.
This document provides an introduction and overview of tablets, including their definition, general properties, advantages, disadvantages, and classification. It discusses the main types of tablets based on use, structure, and action. The document also covers tablet design and formulation, describing the various excipients used (diluents, binders, disintegrants, lubricants) and their functions. It provides examples of different tablet types and dosage forms, such as chewable, dispersible, effervescent, and sublingual tablets.
This document provides information on quality management and quality control processes for pharmaceutical products. It discusses key concepts like quality assurance, quality control, quality management systems. It also summarizes the differences between quality assurance and quality control. The document then describes various quality control tests conducted on tablets and capsules, including tests of general appearance, hardness, friability, disintegration. It provides details on the purpose, procedures, and acceptance limits for these quality control tests.
COMPARATIVE EVALUATION OF DIFFERENT PARACETAMOL BRANDSShikha Popali
THE PARACETAMOL TABLETS IS COMMONLY TAKEN AND PRESCRIBED FOR FEVER , SO HERE WE HAVE MADE PRACTICAL IS IT TRUE EVALUATION LABEL AND WHICH BRAND IS MORE SAFE.
The document outlines the evaluation of various solid, semi-solid, and liquid dosage forms. For solid dosage forms like tablets, important tests include general appearance, weight variation, content uniformity, hardness, friability, disintegration, and dissolution. These tests are conducted to ensure quality, consistency in drug content between tablets, and that the drug will release and dissolve properly. Similar tests are described for other dosage forms like capsules, granules, powders, ointments, creams, suppositories, syrups, suspensions, emulsions, and novel delivery systems. The goal of evaluation is to quantify properties and assess interactions that impact drug stability and bioavailability.
TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.Amruta Sonawane
This document summarizes key tests performed on pharmaceutical formulations, including content uniformity, hardness, and dissolution. Content uniformity testing ensures each tablet contains the intended amount of active drug with little variation between tablets. Hardness testing measures a tablet's crushing strength, with limits varying based on the type of tablet. Dissolution testing predicts in vivo drug release profiles using basket or paddle apparatus under set conditions to simulate gastrointestinal fluids. These tests help ensure consistent dosing, sufficient strength, and controlled drug release.
Novel Approach of Layered Tablet TechnologyNusrat Jahan
This document discusses layered tablets, specifically bi-layer and multi-layer tablets. It begins with an introduction to layered tablets, including their types and approaches. Bi-layer tablets are described as having two layers that can separate incompatible substances or provide sustained and immediate release. Multi-layer tablets are discussed as having benefits like preventing drug-excipient incompatibility. The document outlines challenges in bi-layer manufacturing like delamination. It also discusses various techniques for layered tablets, types of tablet presses, formulation and evaluation methods, and approaches for multi-layer tablet design and technology.
Preparation and Evaluation of Aspirin tabletsSanket Kapadne
PREPARATION AND EVALUATION OF ASPIRIN TABLETS
Aim - Preparation and Evaluation of Aspirin Tablets.
Requirement –
Chemicals - Aspirin, HPMC, PVP, Sodium
Stearate, Talc
Glasswares - Granulating sieve, standard sieve set, etc.
Equipment - Tablet press
Principle
Aspirin tablet is prepared by wet granulation method. Aspirin belonging to the class of NSAID having analgesic, antipyretic, anti-inflammatory and antiplatelet activity at systematic standard doses. In this Lubricants in combination leads to better drug release kinetic. Aspirin tablets are obtained by wet Compression Method. The particles to be compressed consist of one or more medicaments, with or without excipients substance such as diluents, binders, and disintegration agents, lubricant, glidants.
Formula
Sr. No. Ingredients Quantity (1 Tab.)
1. Aspirin 250 mg
2. HPMC 50 mg
3. Microcrystalline Cellulose 70 mg
4. Polyvinyl Pyrrolidone Q.S.
5. Sodium Stearate+ Talc 1 mg + 5 mg
Method
Wet granulation forms the granulation by binding the powders together with an adheshive instead of by compaction.
Stages of granule development :
A. Pendular B. Funicular
C. Capillary D. Droplet Steps involved :
Step 1: Weighing and mixing of formulation ingredients.
Step 2: Preparing the damp mass.
Step 3: Screening the dampened powder into pellets or granules.
Step 4: Drying of moist granules.
Procedure
1. Tablets were prepared using wet granulation technique as per the composition given earlier.
2. The calculated amount which was required to prepare 400 mg aspirin tablets, containing 250 mg drug, HPMC polymer and PVP as a binder were mixed uniformly.
3. An enough granulating agent (water) was added slowly to prepare wet mass. Granules were prepared by sieving method using a 20# sieve.
4. Further, granules were dried at 35-45ºC for six hours. The dried granules were stored in desiccators until compression of tablets.
5.The required amounts of granules were weighed and compressed using automatically operated tablet punching machine having 12mm flat faced punch diameter and during the tablet preparation to maintain the low resistance between the solid and die wall, lubricants added in granules. Lubricant combinations are agents added in small quantities to the tablet during the tablet preparation.
6. The compressed tablets were stored in airtight container at room temperature for further evaluation.
Evaluation
1. Assay : Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 0.5 g of Aspirin, add 30.0 ml of 0.5M sodium hydroxide, boil gently for 10 minutes, cool and titrate the excess of alkali with 0.5 M hydrochloric acid using phenol red solution as indicator. Repeat the operation without the substance under examination. The difference
This document evaluates various properties of tablets including size, shape, thickness, friability, weight variation, disintegration, and dissolution. It describes common tests used to analyze these properties, including friability testing to measure how easily tablets crumble, weight variation testing to check consistency of tablet weights, disintegration testing using glass tubes in fluid, and dissolution testing using apparatus 1 (basket type) or apparatus 2 (paddle type) to measure how quickly drugs dissolve. The document provides details on procedures, equipment, and standards used for these pharmaceutical quality control tests.
Quality control tests are important to ensure tablets meet standards for safety, efficacy and patient acceptability. Key tests include weight variation, hardness, friability, disintegration and dissolution. Weight variation tests if individual tablet weights match the average weight. Hardness ensures tablets can withstand manufacturing and handling stresses. Friability tests surface strength and disintegration confirms how quickly tablets break down in fluid. Dissolution determines the rate of drug release.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document provides information on quality control tests for tablet dosage forms as per the Indian Pharmacopoeia 2018. It discusses tests like uniformity of weight, uniformity of content, friability, disintegration, and dissolution. The uniformity of weight test ensures that tablets are of uniform weight by measuring the percentage deviation from the average weight. The uniformity of content test checks dosage uniformity by determining the active ingredient content in individual tablets. The friability test measures the physical strength of uncoated tablets. The disintegration test specifies the time required for tablets to disintegrate fully in a liquid medium, while the dissolution test determines the amount of active ingredient released over time in a specified liquid.
Tablet friability,harness and dissolution testingdonjacob81
Tablet friability, hardness, and dissolution are important quality control tests. Friability tests measure a tablet's ability to withstand abrasion without breaking, with less than 1% weight loss indicating it can withstand manufacturing and shipping stresses. Hardness tests measure a tablet's resistance to breaking, with 4-10 kg generally considered a minimum. Dissolution tests evaluate how quickly an active ingredient is released from a tablet, which affects how well it can be absorbed in the body.
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
The Formulation of Pacing (Costus speciosus) Extract Tablet By Using Avicel®P...UniversitasGadjahMada
Pacing (Costus speciosus) is an herbaceous plant that is native to Indonesia and it can be used as a male contraceptive due to spermatogenesis inhibition. The purpose of this study is to find out the composition of optimum Avicel PH 200® as the filler-binder and amylum as the disintegration agent and to find out the variations on physical properties of the powder and tablet. Tablets of Costus speciosus extract (CS tablet) were produced by direct compression in 8 runs based on Simplex Lattice Design (SLD) from Design Expert 7.1.5. Evaluation on physical properties of powder included tapping index, water absorption, and moisture content, while evaluation on the physical properties of tablet included hardness, friability, and disintegration time. The results showed that the variation in the composition between Avicel® PH 200 as the filler-binder and amylum as the disintegration agent had a significant effect on the friability of CS tablet, in which the combination of both materials can increase the friability of the tablet. The optimum formula of CS tablet had a composition of Avicel® PH 200 by 462.5mg and amylum by 37.5mg contained in each tablet.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
This document provides an overview of a seminar presentation on tablet preparation and evaluation methods. The presentation covers various tablet types, formulation additives, preparation techniques like wet and dry granulation and direct compression, compression methods using single punch and rotary tablet presses, and quality control tests for tablets including hardness, thickness, friability, dissolution, disintegration, and content uniformity. Evaluation methods and apparatus for each quality control test are also described. The presentation was delivered by Farheen Unnisa to provide guidance on tablet manufacturing and quality testing.
Sample preparation techniques of solid dosage formsSathish Vemula
Knife mills and blenders are particle size reduction techniques that can be used to disperse solid dosage forms like non-disintegrating tablets for analysis. Mechanical techniques like grinding with a mortar and pestle or milling in a ball mill are commonly used to reduce the particle size and facilitate extraction of drugs from solid oral dosage forms. Agitation techniques like shaking, stirring, vortexing, and sonication are then used to further facilitate dispersion and mixing during sample preparation. The selection of appropriate particle size reduction and agitation techniques depends on the properties of the specific drug product and dosage form being analyzed.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This study isolated starch from the nut of Cola nitida and characterized its physicochemical properties. The isolated kola starch was white, odorless, tasteless with a fine texture. It had a pH of 5.5 and moisture content of 9.67%. Acetylsalicylic acid tablets were formulated using the novel kola starch via direct compression. Tablet properties such as weight uniformity, disintegration time, friability and hardness of the formulated tablets were evaluated based on pharmacopeial standards and compared to three commercial acetylsalicylic acid brands. The results showed that the formulated tablets met pharmacopeial specifications and were not significantly different from the commercial brands, indicating the suitability of using kola starch for
This document summarizes a study that developed and evaluated sustained release matrix tablets containing metformin HCl. Metformin HCl tablets were prepared using beeswax in combination with other hydrophobic materials to produce a hydrophobic matrix that would provide sustained drug release. Tablet formulations were optimized based on acceptable properties and drug release profiles. In vitro drug release studies showed that formulations containing beeswax and cetyl alcohol provided drug release closest to the theoretical release profile. Kinetic modeling indicated the release mechanism followed Higuchi kinetics and was diffusion mediated. Tablets containing higher amounts of cetyl alcohol in place of beeswax showed improved drug release, likely due to increased water penetration in the matrix.
The document discusses solid dosage forms, specifically tablets. It defines tablets and discusses their advantages and disadvantages. It describes different types of tablets classified by their route of administration or function. The document outlines the preparation process for tablets including granule preparation, compression into tablets, and coating. It discusses excipients used and quality control tests performed on tablets.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
This document provides guidance on selecting physical parameters for designing and developing oral solid dosage forms (tablets and capsules) for generic drugs. It discusses key physical attributes like size, shape, tablet scoring and other factors and their impact on generic drug claims and therapeutic outcomes. The document recommends that generic drug manufacturers consider physical attributes like size, shape, scoring and other factors in developing their products to ensure equivalence to the reference brand drug. The physical attributes can impact patient acceptance and compliance. It provides recommendations and criteria for generic drugs to address physical attributes like having similar size and shape as the reference brand and consistent scoring.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
Novel Approach of Layered Tablet TechnologyNusrat Jahan
This document discusses layered tablets, specifically bi-layer and multi-layer tablets. It begins with an introduction to layered tablets, including their types and approaches. Bi-layer tablets are described as having two layers that can separate incompatible substances or provide sustained and immediate release. Multi-layer tablets are discussed as having benefits like preventing drug-excipient incompatibility. The document outlines challenges in bi-layer manufacturing like delamination. It also discusses various techniques for layered tablets, types of tablet presses, formulation and evaluation methods, and approaches for multi-layer tablet design and technology.
Preparation and Evaluation of Aspirin tabletsSanket Kapadne
PREPARATION AND EVALUATION OF ASPIRIN TABLETS
Aim - Preparation and Evaluation of Aspirin Tablets.
Requirement –
Chemicals - Aspirin, HPMC, PVP, Sodium
Stearate, Talc
Glasswares - Granulating sieve, standard sieve set, etc.
Equipment - Tablet press
Principle
Aspirin tablet is prepared by wet granulation method. Aspirin belonging to the class of NSAID having analgesic, antipyretic, anti-inflammatory and antiplatelet activity at systematic standard doses. In this Lubricants in combination leads to better drug release kinetic. Aspirin tablets are obtained by wet Compression Method. The particles to be compressed consist of one or more medicaments, with or without excipients substance such as diluents, binders, and disintegration agents, lubricant, glidants.
Formula
Sr. No. Ingredients Quantity (1 Tab.)
1. Aspirin 250 mg
2. HPMC 50 mg
3. Microcrystalline Cellulose 70 mg
4. Polyvinyl Pyrrolidone Q.S.
5. Sodium Stearate+ Talc 1 mg + 5 mg
Method
Wet granulation forms the granulation by binding the powders together with an adheshive instead of by compaction.
Stages of granule development :
A. Pendular B. Funicular
C. Capillary D. Droplet Steps involved :
Step 1: Weighing and mixing of formulation ingredients.
Step 2: Preparing the damp mass.
Step 3: Screening the dampened powder into pellets or granules.
Step 4: Drying of moist granules.
Procedure
1. Tablets were prepared using wet granulation technique as per the composition given earlier.
2. The calculated amount which was required to prepare 400 mg aspirin tablets, containing 250 mg drug, HPMC polymer and PVP as a binder were mixed uniformly.
3. An enough granulating agent (water) was added slowly to prepare wet mass. Granules were prepared by sieving method using a 20# sieve.
4. Further, granules were dried at 35-45ºC for six hours. The dried granules were stored in desiccators until compression of tablets.
5.The required amounts of granules were weighed and compressed using automatically operated tablet punching machine having 12mm flat faced punch diameter and during the tablet preparation to maintain the low resistance between the solid and die wall, lubricants added in granules. Lubricant combinations are agents added in small quantities to the tablet during the tablet preparation.
6. The compressed tablets were stored in airtight container at room temperature for further evaluation.
Evaluation
1. Assay : Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 0.5 g of Aspirin, add 30.0 ml of 0.5M sodium hydroxide, boil gently for 10 minutes, cool and titrate the excess of alkali with 0.5 M hydrochloric acid using phenol red solution as indicator. Repeat the operation without the substance under examination. The difference
This document evaluates various properties of tablets including size, shape, thickness, friability, weight variation, disintegration, and dissolution. It describes common tests used to analyze these properties, including friability testing to measure how easily tablets crumble, weight variation testing to check consistency of tablet weights, disintegration testing using glass tubes in fluid, and dissolution testing using apparatus 1 (basket type) or apparatus 2 (paddle type) to measure how quickly drugs dissolve. The document provides details on procedures, equipment, and standards used for these pharmaceutical quality control tests.
Quality control tests are important to ensure tablets meet standards for safety, efficacy and patient acceptability. Key tests include weight variation, hardness, friability, disintegration and dissolution. Weight variation tests if individual tablet weights match the average weight. Hardness ensures tablets can withstand manufacturing and handling stresses. Friability tests surface strength and disintegration confirms how quickly tablets break down in fluid. Dissolution determines the rate of drug release.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document provides information on quality control tests for tablet dosage forms as per the Indian Pharmacopoeia 2018. It discusses tests like uniformity of weight, uniformity of content, friability, disintegration, and dissolution. The uniformity of weight test ensures that tablets are of uniform weight by measuring the percentage deviation from the average weight. The uniformity of content test checks dosage uniformity by determining the active ingredient content in individual tablets. The friability test measures the physical strength of uncoated tablets. The disintegration test specifies the time required for tablets to disintegrate fully in a liquid medium, while the dissolution test determines the amount of active ingredient released over time in a specified liquid.
Tablet friability,harness and dissolution testingdonjacob81
Tablet friability, hardness, and dissolution are important quality control tests. Friability tests measure a tablet's ability to withstand abrasion without breaking, with less than 1% weight loss indicating it can withstand manufacturing and shipping stresses. Hardness tests measure a tablet's resistance to breaking, with 4-10 kg generally considered a minimum. Dissolution tests evaluate how quickly an active ingredient is released from a tablet, which affects how well it can be absorbed in the body.
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
The Formulation of Pacing (Costus speciosus) Extract Tablet By Using Avicel®P...UniversitasGadjahMada
Pacing (Costus speciosus) is an herbaceous plant that is native to Indonesia and it can be used as a male contraceptive due to spermatogenesis inhibition. The purpose of this study is to find out the composition of optimum Avicel PH 200® as the filler-binder and amylum as the disintegration agent and to find out the variations on physical properties of the powder and tablet. Tablets of Costus speciosus extract (CS tablet) were produced by direct compression in 8 runs based on Simplex Lattice Design (SLD) from Design Expert 7.1.5. Evaluation on physical properties of powder included tapping index, water absorption, and moisture content, while evaluation on the physical properties of tablet included hardness, friability, and disintegration time. The results showed that the variation in the composition between Avicel® PH 200 as the filler-binder and amylum as the disintegration agent had a significant effect on the friability of CS tablet, in which the combination of both materials can increase the friability of the tablet. The optimum formula of CS tablet had a composition of Avicel® PH 200 by 462.5mg and amylum by 37.5mg contained in each tablet.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
This document provides an overview of a seminar presentation on tablet preparation and evaluation methods. The presentation covers various tablet types, formulation additives, preparation techniques like wet and dry granulation and direct compression, compression methods using single punch and rotary tablet presses, and quality control tests for tablets including hardness, thickness, friability, dissolution, disintegration, and content uniformity. Evaluation methods and apparatus for each quality control test are also described. The presentation was delivered by Farheen Unnisa to provide guidance on tablet manufacturing and quality testing.
Sample preparation techniques of solid dosage formsSathish Vemula
Knife mills and blenders are particle size reduction techniques that can be used to disperse solid dosage forms like non-disintegrating tablets for analysis. Mechanical techniques like grinding with a mortar and pestle or milling in a ball mill are commonly used to reduce the particle size and facilitate extraction of drugs from solid oral dosage forms. Agitation techniques like shaking, stirring, vortexing, and sonication are then used to further facilitate dispersion and mixing during sample preparation. The selection of appropriate particle size reduction and agitation techniques depends on the properties of the specific drug product and dosage form being analyzed.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This study isolated starch from the nut of Cola nitida and characterized its physicochemical properties. The isolated kola starch was white, odorless, tasteless with a fine texture. It had a pH of 5.5 and moisture content of 9.67%. Acetylsalicylic acid tablets were formulated using the novel kola starch via direct compression. Tablet properties such as weight uniformity, disintegration time, friability and hardness of the formulated tablets were evaluated based on pharmacopeial standards and compared to three commercial acetylsalicylic acid brands. The results showed that the formulated tablets met pharmacopeial specifications and were not significantly different from the commercial brands, indicating the suitability of using kola starch for
This document summarizes a study that developed and evaluated sustained release matrix tablets containing metformin HCl. Metformin HCl tablets were prepared using beeswax in combination with other hydrophobic materials to produce a hydrophobic matrix that would provide sustained drug release. Tablet formulations were optimized based on acceptable properties and drug release profiles. In vitro drug release studies showed that formulations containing beeswax and cetyl alcohol provided drug release closest to the theoretical release profile. Kinetic modeling indicated the release mechanism followed Higuchi kinetics and was diffusion mediated. Tablets containing higher amounts of cetyl alcohol in place of beeswax showed improved drug release, likely due to increased water penetration in the matrix.
The document discusses solid dosage forms, specifically tablets. It defines tablets and discusses their advantages and disadvantages. It describes different types of tablets classified by their route of administration or function. The document outlines the preparation process for tablets including granule preparation, compression into tablets, and coating. It discusses excipients used and quality control tests performed on tablets.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
This document provides guidance on selecting physical parameters for designing and developing oral solid dosage forms (tablets and capsules) for generic drugs. It discusses key physical attributes like size, shape, tablet scoring and other factors and their impact on generic drug claims and therapeutic outcomes. The document recommends that generic drug manufacturers consider physical attributes like size, shape, scoring and other factors in developing their products to ensure equivalence to the reference brand drug. The physical attributes can impact patient acceptance and compliance. It provides recommendations and criteria for generic drugs to address physical attributes like having similar size and shape as the reference brand and consistent scoring.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
Formulation and evaluation of Furosemide oral dispersible tabletsSriramNagarajan18
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QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
This document provides information about tablet formulations and manufacturing. It discusses the main components of tablets including active ingredients and excipients like diluents, binders, disintegrants and lubricants. It describes different types of tablets and coating methods. Tablet evaluation methods are outlined including tests for hardness, friability, drug content and dissolution. The advantages and disadvantages of tablet formulations are also summarized.
DESIGN AND EVALUATION OF ORODISPERSIBLE TABLETS OF PANTOPRAZOLE SODIUMReshma Fathima .K
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The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
Preparation and evaluation of deferasirox effervescent release tabletsSriramNagarajan19
This document describes the formulation and evaluation of effervescent release tablets containing the drug deferasirox. Six formulations of effervescent tablets were prepared using different concentrations of effervescent agents (citric acid and sodium bicarbonate). The formulations demonstrated acceptable pre-compression and post-compression properties. In vitro dissolution studies showed that formulation F6 had the best drug release profile, releasing over 94% of the drug within 60 minutes. Stability studies of the optimized F6 formulation were conducted according to ICH guidelines. Overall, the study demonstrated the successful preparation of effervescent release tablets containing deferasirox with a dissolution profile similar to the reference product.
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
The document describes the formulation and evaluation of ibuprofen suspension using natural and synthetic suspending agents. Four ibuprofen suspensions were prepared using different combinations of methylcellulose, fenugreek seed powder, and other excipients. The suspensions were evaluated for sedimentation volume, particle size, viscosity, pH, drug content, and in-vitro drug release. The F4 formulation containing both fenugreek seed powder and methylcellulose showed the best stability profile compared to the other formulations in the various evaluation tests.
The main objective of present investigation is to formulate the floating tablets of
Ranitidine.HCl using 32 factorial design. Ranitidine.HCl, H2-receptor antagonist belongs to
BCS Class-III. The Floating tablets of Ranitidine.HCl were prepared employing different
concentrations of HPMCK4M and Guar Gum in different combinations as a release rate
modifiers by Direct Compression technique using 32 factorial design. The concentration of
Polymers , HPMCK4M and Guar Gum required to achieve desired drug release was selected
as independent variables, X1 and X2 respectively whereas, time required for 10% of drug
dissolution (t10%), 50% (t50%), 75% (t75%) and 90% (t90%) were selected as dependent variables.
Totally nine formulations were designed and are evaluated for hardness, friability, thickness,
% drug content, Floating Lag time, In-vitro drug release. From the Results concluded that all
the formulation were found to be within the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the
statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated.
Polynomial equations were developed for t10%, t50%, t75%, t90%. Validity of developed
polynomial equations were verified by designing 2 check point formulations(C1, C2).
According to SUPAC guidelines the formulation (F5) containing combination of 22.5%
HPMCK4M and 22.5% Guar Gum, is the most similar formulation (similarity factor f2=85.01,
dissimilarity factor f1= 15.358 & No significant difference, t= 0.169) to marketed product
(ZANTAC). The selected formulation (F5) follows Higuchi’s kinetics, and the mechanism of
drug release was found to be Non-Fickian Diffusion (n= 0.922).
Background: The main objective of present research work is to formulate the Carbamazepine Fast Dissoving tablets. Carbamazepine, an
antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by
blocking use-dependent sodium channels. Methods: The Fast Dissoving tablets of Carbamazepine were prepared employing different
concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Sperdisintegrants by Direct Compression technique
using 32
factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1
and X2 respectively whereas, wetting time, Disintegration time, t
50% ,t90%were selected as dependent variables. Results and Discussion:
Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, Invitro
drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations (C1
, C2
). According to SUPAC guidelines the
formulation (F5
) containing combination of 9.375% Crospovidone and 9.375% Croscarmellose, is the most similar formulation (similarity factor
f
2
=82.675, dissimilarity factor f1
= 2.049 & No significant difference, t= 0.041) to marketed product (TEGRETOL-100). Conclusion: The
selected formulation (F5
) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.665).
KEYWORDS: Carbamazepine, 3
2Factorial Design, Crospovidone , croscarmellose Sodium, Wetting Time, Disintegration Time.
1. The document describes the formulation and evaluation of prolonged release metformin hydrochloride tablets. Tablets were prepared by direct compression and wet granulation methods using polymers like Polyox-303 to sustain the release of the drug.
2. Tablets were evaluated for pre-compression and post-compression parameters. In-vitro dissolution and stability studies showed that the formulations had a controlled release of the drug over an extended period of time.
3. The optimized formulation was stable for 1 month under accelerated conditions as per ICH guidelines.
This document describes the development and evaluation of carvedilol phosphate gastroretentive floating tablets using a 32 factorial design. Carvedilol phosphate is a drug that belongs to BCS Class II and is indicated for hypertension and heart failure. Floating tablets were prepared using varying concentrations of guar gum and sodium bicarbonate as polymers to control the release of the water soluble drug. Nine formulations were designed and evaluated for properties like drug content, floating lag time, and in vitro drug release using kinetic models. The results showed that all formulations met pharmacopeial standards and formulation F8 containing 25% guar gum and 3.75% sodium bicarbonate best matched the marketed product with respect to drug release.
This document discusses tablets as a type of solid oral dosage form. It defines tablets and describes their advantages such as low cost, ease of administration and stability. It discusses the various ingredients that make up tablets, including diluents, binders, disintegrants and lubricants. It also describes different types of tablets and how they are manufactured through processes like granulation and compression using tablet presses. The document outlines how to evaluate tablets in terms of appearance, hardness, friability, drug content and dissolution. Finally, it discusses tablet coating and the various coating processes and equipment used.
This document discusses tablets as a type of solid oral dosage form. It defines tablets and describes their advantages such as low cost, ease of administration and stability. It discusses the various ingredients that make up tablets, including diluents, binders, disintegrants and lubricants. It also describes different types of tablets and how they are manufactured through processes like granulation and compression using tablet presses. The document outlines how to evaluate tablets in terms of properties like hardness, friability, drug content and dissolution. Finally, it discusses tablet coating and the various coating processes and equipment used.
Preparation and Evaluation of Immediate Release Tabletsijtsrd
Background Tablet is that the preferred among all dosage forms existing today thanks to its convenience of self administration, compactness and simple manufacturing however in many cases immediate onset of action is required than conventional therapy. There are novel kinds of dosage form.The scenario of pharmaceutical drug delivery are expeditiously challenging, but conventional pharmaceutical dosage forms are still dominating. Immediate release dosage forms are those wherein =85 of labeled amount dissolves within 30 min. Superd is integrants are accustomed improve the efficacy of solid dosage forms. orms that act very quickly after administration To overcome these drawbacks, immediate release pharmaceutical dosage form has emerged as alternative oral dosage forms. There are novel forms of dosage forms that act very quickly after administration. the fundamental approach utilized in development tablets is that the use of superdisintegrants like Cross linked carboxymelhylcellulose Croscarmeliose , Sodium starch glycolate Primogel, Explotab , Polyvinylpyrrolidone Polyplasdone etc. which give instantaneous disintegration of tablet after administration. Immediate release liquid dosage forms and parenteral dosage form have also been introduced for treating patients. Dosage form can be suspensions with typical dispersion agents like hydroxypropylmethylcellulose, dioctylsulfosuccinate etc. a replacement dosage form allows a manufacturer to increasemarket exclusivity, while offering its patient population a more convenient dosage form or dosing regimen.These superdisintegrants provide instantaneous disintegration of the tablet after administration within the stomach. This article provide an exhaustive account illustrating the significances of superdisintegrant within the immediate release of tablets and therefore the mechanism of disintegration together with various conventional techniques and novel granulation technology wont to prepare immediate release tablets. ach. Thus, decreasing the disintegration time which successively enhances drug dissolution rate. Results From this review, we can ready to develop and evaluate immediate release tablets.also we must always understand role of immediate release tablets.Conclusion Most of the patients need quick therapeutic action of the drug, leading to poor compliance with conventional drug therapy which results in reduced overall therapy effectiveness. For this we will conclude that immediate release tablets are simpler. because immediate release tablet shows quick effect. Sakshi Ghuge | Prof. Smita More "Preparation and Evaluation of Immediate Release Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-1 , December 2020, URL: https://www.ijtsrd.com/papers/ijtsrd35867.pdf Paper URL : https://www.ijtsrd.com/pharmacy/pharmaceutics/35867/preparation-and-evaluation-of-immediate-release-tablets/sakshi-ghuge
This document describes quality control tests that are performed on tablets to ensure they meet specifications. It discusses tests like physical examination, thickness, diameter, weight variation, hardness, friability, disintegration and dissolution. The physical examination checks for defects, thickness and diameter tests uniformity, weight variation tests content uniformity, hardness tests strength, friability tests fragility, disintegration tests breakdown into particles and dissolution tests release of drug in fluid. The document provides details on the principles, procedures, requirements and reports for each of these quality control tests performed on tablets.
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Formulation and In vitro evaluation of Fosinopril fast dissolving tablets
1. Shagani R et al / Int. J. of Farmacia, 2016; Vol-(2) 4: 217-224
217
International Journal of Farmacia
Journal Home page: www.ijfjournal.com
Formulation and In vitro evaluation of Fosinopril fast dissolving tablets
Shagani Raju*, Santhosh kumar kasula
Procadence Institute of Pharmaceutical sciences, Pregnapur, Telangana.
Corresponding Author: Shagani Raju
*
E-mail: rajuyadav7727@gmail.com
ABSTRACT
The concept of formulating fast dissolving tablets using super disintegrants offers a suitable and practical
approach of faster disintegration and dissolution characteristics. The formulations F1 to F9 Were
prepared. Among the various method of preparation fast dissolving tablets were prepared by using super
disintegrants like CCS, CP and SSG by direct compression. The formulations F1 to F3 are prepared with 10%
concentration of CCS, CP and SSG. The formulations F4 to F6 are prepared with 15% concentration of CCS, CP
and SSG. The formulations F7 to F9 are prepared with 20% concentration of CCS, CP and SSG. The prepared
tablets of fosinopril were evaluated for precompression parameters like angle of repose, bulk density,
tapped density, Carr’s index and postcompression parameters like the hardness, friability and weight
variation, drug content, disintegration time, and IN VITRO dissolution studies. Among the various fast dissolving
tablets of fosinopril F7 formulation shows maximum drug release in 30min.
Keywords: Fosinopril, CCS, CP and SSG.
INTRODUCTION
Oral solid dosage forms
A solid dosage form is drug delivery system that
includes tablets, capsules, sachets and pills as well as
a bulk or unit-dose powders and granules. Among the
various dosage forms oral soliddosage forms have
greater importance and occupy a prime role in the
pharmaceutical market. Oral route of drug
administration is widely acceptable and drugs
administered orally as solid dosage form represents
the preferred class of products. Over 90% of drugs
formulated to produce systemic effects are produced
as solid dosage forms. Because of these reason
whenever New chemical entity (NCE) has discovered,
which shows a sufficient pharmacological action, first
the pharmaceutical company asks whether the drug is
successfully administered by oral route or not. The
oral route of administration still continues to be the
most preferred route due to its manifold advantages
[5].
Tablets and capsules represent unit dosage forms
in which the accurate dose of drug to show sufficient
pharmacological action can be administered. In case
of liquid oral dosage forms such as Syrups,
Suspensions, Emulsions, Solutions and Elixirs the
patient is asked to administer the medication of 5-30
ml. Such dosage measurements are typically error by
factor ranging from 20-50 %, when the drug is self
administered by patient [6]. Solid dosage forms are
less expensive to shipping and less prone for the
degradation when compared to liquid dosage forms
[4].
In 1843, the first patent for a hand operated device
used to form a tablet was granted.” Tablets are
defined as solid preparations each containing a single
dose of one or more active ingredients and obtained
by compressing uniform volumes of particles. They
are intended for oral administration, some are
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218
swallowed whole, some after being chewed. Some are
dissolved or dispersed in water before being
administered and some are retained in the mouth,
where the active ingredient “liberated”. Tablets are
used mainly for systemic drug delivery but also for
local drug action. For systemic use drug must be
released from tablet that is dissolved in the fluids of
mouth, stomach and intestine and then absorbed into
systemic circulation by which it reaches its site of
action [8]. Tablets remain popular as a dosage form
because of the advantages, afforded both to the
manufacturer [e.g. simplicity and economy of
preparation, stability and convenience in packing,
shipping and dispensing] and the patient [e.g.
accuracy of dosage, compactness, portability,
blandness of taste and ease of administration [10].
They may differ greatly in size and weight
depending on the amount of drug substance present
and the intended method of administration [2]. They
may have lines or break-marks and may bear a
symbol or other markings. Tablets may be coated.
MATERIALS AND METHODS
Table 1: Formulation of fosinopril fast dissolving tablets
Ingredients(mg) F1 F2 F3 F4 F5 F6 F7 F8 F9
Fosinopril 10 10 10 10 10 10 10 10 10
SSG 10 15 20
CCS 10 15 20
CP 10 15 20
Mg.stearate 5 5 5 5 5 5 5 5 5
Talc 5 5 5 5 5 5 5 5 5
PVP K30 10 10 10 10 10 10 10 10 10
Sodium bicarbonate - -- - - - - 10 10 10
MCC q.s q.s q.s q.s q.s q.s q.s q.s q.s
Total weight 200 200 200 200 200 200 200 200 200
Formulation Planning
The fast dissolving tablets containing 10mg
Fosinopril were prepared with a total tablet weight of
200mg.
Manufacturing Procedure
Micro crystalline cellulose, cross Carmellose
sodium/sodium starch glycolate/cross povidone,
PVP were weighed and sifted through 40 mesh.
To the above blend Fosinopril was added and
sifted through 18 mesh.
The sifted material was placed in poly bag and
mixed for 5 min.
To the above blend add mg.stearate and Talc,
and this lubricated blend was added and placed
in poly bag and mixed for 2-3 min.
The lubricated blend was compressed using 8
mm round punches.
Evaluation of tablets
The quantitative evaluation and assessment of a
tablets chemical, physical and bioavailability
properties are important in the design of tablets and to
monitor product quality. There are various standards
that have been set in the various pharmacopoeias
regarding the quality of pharmaceutical tablets. These
include the diameter, size, shape, thickness, weight,
hardness, disintegration and dissolution characters.
Physical Appearance
The general appearance of a tablet, its identity and
general elegance is essential for consumer acceptance,
for control of lot-to-lot uniformity and tablet-to-tablet
uniformity. The control of general appearance
involves the measurement of size, shape, colour,
presence or absence of odour, taste etc.
Size & Shape
It can be dimensionally described & controlled.
The thickness of a tablet is only variables. Tablet
thickness can be measured by micro-meter or by other
device. Tablet thickness should be controlled within a
± 5% variation of standard value.
Weight variation test
This is an in process quality control test to ensure
that the manufacturers control the variation in the
weight of the compressed tablets, different
pharmacopoeia specify these weight variation tests.
These tests are primarily based on the comparison of
the weight of the individual tablets of a sample of
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tablets with an upper and lower percentage limit of
the observed sample average. The USP has provided
limits for the average weight of uncoated compressed
tablets. These are applicable when the tablet contains
50mg or more of the drug substance or when the latter
comprises 50% or more, by weight of the dosage
form.
Method
Twenty tablets were weighed individually and the
average weight was calculated. The individual tablet
weights are then compared to the average weight. Not
more than two tablets should differ in their average
weight by more than percentages stated in USP. No
tablet must differ by more than double the relevant
percentage.
Table 2: limits for tablet weight variation test
Average weight of tablet (mg) % Difference allowed
130 or less 10%
From 130 to 324 7.5%
> 324 5%
Content Uniformity
The content uniformity test is used to ensure that
every tablet contains the amount of drug substance
intended with little variation among tablets within a
batch. Due to increased awareness of physiological
availability, the content uniformity test has been
included in the monographs of all coated and
uncoated tablets and all capsules intended for oral
administration where the range of size of the dosage
form available include 50mg or smaller sizes.
Method
Randomly select 30 tablets. 10 of these assayed
individually. The Tablet pass the test if 9 of the 10
tablets must contain not less than 85% and not more
than 115% of the labeled drug content and the 10th
tablet may not contain less than 75% and more than
125% of the labeled content. If these conditions are
not met, remaining 20 tablets assayed individually
and none may fall outside of the 85 to 115% range.
Thickness and diameter
The thickness and diameter of 10 tablets were
recorded during the process of compression using
vernier calipers.
Hardness
Hardness, which is now more appropriately called
crushing strength determinations are made during
tablet production and are used to determine the need
for pressure adjustment on tablet machine. If the
tablet is too hard, it may not disintegrate in the
required period of time to meet the dissolution
specifications; if it is too soft, it may not be able to
withstand the handling during subsequent processing
such as coating or packaging and shipping
operations.The force required to break the tablet is
measured in kilograms. The small and portable
hardness tester measures the force required to break
the tablet when the force generated by a coil spring is
applied diametrically to the tablet.
Friability
Friction and shock are the forces that most often
cause tablets to chip, cap or break. The friability test
is closely related to tablet hardness and designed to
evaluate the ability of the tablet to withstand abrasion
in packaging, handling and shipping. It is usually
measured by the use of the Roche friabilator.
Method
A number of tablets are weighed and placed in the
apparatus where they are exposed to rolling and
repeated shocks as they fall 6 inches in each turn
within the apparatus. After four minutes of this
treatment or 100 revolutions, the tablets are weighed
and the weight compared with the initial weight. The
loss due to abrasion is a measure of the tablet
friability. The value is expressed as a percentage. A
maximum weight loss of not more than 1% of the
weight of the tablets being tested during the friability
test is considered generally acceptable and any broken
or smashed tablets are not picked.
The percentage friability was determined by
the formula
% Friability = (W1-W2) / W1 X 100
W1 = Weight of tablets before test
W2 = Weight of tablets after test
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Disintegration test
For a drug to be absorbed from a solid dosage
form after oral administration, it must first be in
solution, and the first important step toward this
condition is usually the break-up of the tablet; a
process known as disintegration. The disintegration
test is a measure of the time required under a given set
of conditions for a group of tablets to disintegrate into
particles which will pass through a 10 mesh screen.
Generally, the test is useful as a quality assurance tool
for conventional dosage forms.
Method
The U.S.P. device to test disintegration uses 6
glass tubes that are open at the top and 10 mesh
screen at the bottom end. To test for disintegration
time, one tablet is placed in each tube and the basket
rack is positioned in a 1-L beaker of water, simulated
gastric fluid or simulated intestinal fluid at 37 ± 20
C
such that the tablet remain 2.5 cm below the surface
of liquid on their upward movement and not closer
than 2.5 cm from the bottom of the beaker in their
downward movement. Move the basket containing the
tablets up and down through a distance of 5-6 cm at a
frequency of 28 to 32 cycles per minute. Floating of
the tablets can be prevented by placing perforated
plastic discs on each tablet. According to the test the
tablet must disintegrate and all particles must pass
through the 10 mesh screen in the time specified. If
any residue remains, it must have a soft mass. If one
or two tablets fail to disintegrate, the test is repeated
using 12 tablets.
Disintegration time: Uncoated tablet: 5-30 minutes.
Dissolution
Dissolution is the process by which a solid solute
enters a solution. In the pharmaceutical industry, it
may be defined as the amount of drug substance that
goes into solution per unit time under standardized
conditions of liquid/solid interface, temperature and
solvent composition. Dissolution is considered one of
the most important quality control tests performed on
pharmaceutical dosage forms and is now developing
into a tool for predicting bioavailability.
Dissolution
Stability studies [11]
The stability study of the formulations were
carried out according to ICH guidelines at 40 ± 2o
C/75 ± 5 % RH for one month by storing the samples
in stability chamber (Lab-care, Mumbai).
The purpose of stability testing is to provide
evidence of the quality of the drug substance ordrug
product, and how it varies with time under the
influence of a variety of environmental conditions
(heat, humidity, light, air etc).
The final formulation was packed in suitable
packing like blister and strip packs and then they will
be kept at different temperature, humidity conditions
and the samples will be analyzed for their physical
and chemical properties.
Table 3: Stability studies Storage conditions
Study Storage conditions Minimum time period
covered by data at submission.
Long term
Intermediate
Accelerated
25 2o
c / 60 5% RH
or
30 2o
c / 75 5% RH
30 2o
c / 65 5% RH
40 2o
c / 75 5% RH
12 months
6 months
6 months
RESULTS AND DISCUSSION
Compatibility studies
Drug polymer compatibility studies
FT-IR spectroscopy was employed to ascertain the
compatibility of Fosinopril with polymers. The
individual drug and drug with polymers were
separately scanned. Both the spectra were compared
for confirmation of common peaks. Fosinopril with
polymers showed no significant variation in height,
intensity and position of peaks, suggesting that drug
and excipients were compatible. There is no
interaction between drug and polymer. Hence, it can
be concluded that the drug is in free state and can
release easily from the formulation the spectra are
reported in the table
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Fig No 1: Ftir Spectra of pure drug
Fig 2: FTIR Spectra of optimized formulation
Table 4: FT-IR Spectra data of FOSINOPRIL fast dissolving tablets
S.
No
Functional
group
Characteristic peak
cm-1
Observed peak for drug
cm-1
Peaks for optimized
formulation
1 P=O 1300 -1250 1278 1278.55
2 C-N=O 1600 - 1500 1503 1580
3 -CH3 2960 - 2850 2867 2850
Evaluation of Blend
Table 5: Micromeritic properties
Formulation
code
Bulk density,
gm/ml
Tapped
density, gm/ml
Carr’s
index %
Hausner
ratio
Angel of
repose
F1 0.453 0.689 34.252 1.520 25
F2 0.489 0.710 31.126 1.451 22
F3 0.710 0.873 19.714 1.251 26
F4 0.721 0.870 17.126 1.206 27
F5 0.718 0.871 18.513 1.223 28
F6 0.410 0.483 15.113 1.178 24
F7 0.420 0.482 15.010 1.131 25
F8 0.541 0.691 21.62 1.276 25
F9 0.484 0.615 21.30 1.270 27
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Evaluation of Tablets
Table 6: Post compression studies
Formulation
code
Weight
variation
Hardness
( kg/cm2
)
Friability
(%)
Thickness
(mm)
Content
uniformity
Disintegration
Time (min)
F1 198 6.5 0.65 3.41mm 99.28 4 min 24 sec
F2 198 6.3 0.67 3.43mm 99.16 5 min
F3 199 6.0 0.68 3.45mm 101.1 5 min
F4 200 6.4 0.64 3.42mm 98.68 2min
F5 200 6.1 0.64 3.44mm 99.41 4 min
F6 201 6.0 0.65 3.42mm 102.6 3 min
F7 198 6.2 2.3 3.4mm 99.28 1 min
F8 198 6.5 1.8 3.4mm 99.5 1min 45 sec
F9 200 6.3 0.68 3.43mm 99.6 1min 50 sec
In -vitro drug release study
Paddle method Dissolution data of fast dissolving
formulations of Fosinopril by Paddle method (USP II)
are reported in Table14.
Table 7: Dissolution Profile
Time in min F1 F2 F3 F4 F5 F6 F7 F8 F9
5 15 11 14 17 18 20 21 20 22
10 24 20 26 28 29 34 55 49 34
15 38 31 34 42 36 48 63 58 45
20 46 43 47 54 45 59 88 72 67
30 68 60 52 72 66 66 98.7 89 80
45 75 70 68 97 79 83 90 95.6
60 87 81 85 86 94
Figure 3: Cumulative % drug release for formulations F1-F9
Stability studies
Fosinopril tablets of F7 formulation were packed
in HDPE (High density polyethylene) container with
child resistant caps (CRC) and induction sealed.
These bottles were charged for stability study at 400
C
&75% RH.
0
20
40
60
80
100
120
0 10 20 30 40 50 60 70
cumulative%drugrelease
time in min
F1
F2
F3
F4
F5
F6
F7
F8
F9
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After one month
Table 8 Physical evaluation of Tablets for stability studies of Optimized formulation:
Parameter Initial 400
C / 75%RH
Colour white White
Surface Smooth Smooth
Disintegration(min) 1min 1min 20 sec
Assay 99.28 99.0
Observation
The Fosinopril tablets were subjected to stability
studies at 40o
C and 75% RH for 1 month and from the
above results, it was found that there is no significant
effect on the tablets
After Three months
Table 9 Physical evaluation of Tablets for stability studies of optimized formulation:
Parameter Initial 400
C / 75%RH
Colour white White
Surface Smooth Smooth
Disintegration (min) 1min 1min 22 sec
Assay 99.28 98.7
Observation
The Fosinopril tablets were subjected to stability
studies at 40o
C and 75% RH for 3 months and from
the above results, it was found that there is no effect
on the tablets and was found to be with in the limits
according to ICH guidelines.
CONCLUSION
The concept of formulating fast dissolving
tablets using super disintegrants offers a suitable
and practical approach of faster
disintegration and dissolution characteristics.
Among the various method of preparation fast
dissolving tablets were prepared by using super
disintegrants like CCS, CP and SSG by direct
compression.The prepared tablets of fosinopril
were evaluated for precompression parameters
like angle of repose, bulk density, tapped
density, Carr’s index and postcompression
parameters like the hardness, friability and weight
variation, drug content, disintegration time, and in
vitro dissolution studies. Among the various fast
dissolving tablets of fosinopril F7 formulation
shows maximum drug release in 30min.
REFERENCES
[1]. Yadav IK, Jaiswal D, Sing HP, Chandra D, Jain DA. Formulation Evaluation and Optimization of fast
Dissolving Tablets containing NimesulideMicropellets. Int J ChemTech 1(4), 2009, 910-4.
[2]. Deshmukh SS, Potnis VV, Mahaparale PR, Kasture PV, Gharge VS et al. Development and Evaluation of
Ziprasidone Hydrochloride Fast Disintegrating/Dissolving Tablets using Complexation Techniques. Ind J
Pharm educ 43(3), 2009, 300-307.
[3]. Godge RK, Kendre PN, Giri MA, Syed MZ, Syed NL et al. Formulation and In-Vitro Evaluation of Fast
Dissolving/Disintegrating tablets of Tizanidine Hydrochloride. Research J Pharma Dosage Form and Tech;
1(1), 2009, 55-8.
[4]. Tripathi K.D. Essentials of medical pharmacology, Japeebrothers medical Publishers (P) Ltd 6, 2008, 449-50.
[5]. Indian pharmacopoeia commission Central Indian Pharmacopoeia Laboratory Govt of India,Ministry of Health
and Family Welfare Sector23,RajnagarIndian Ghaziabad.(2), 2007 , 905.
[6]. Orveleyn S, Remon JP. Formulation and Production of rapidly disintegrating tablets by lyophilisation using
hydrochlorothiazide as a model drug. Int J Pharm 152, 1997, 215-25.
8. Shagani R et al / Int. J. of Farmacia, 2016; Vol-(2) 4: 217-224
224
[7]. Ahemed IS, Aboul-Einien MH. IN-vitro and In-vivo evaluation of a fast disintegrating lyophilized dry emulsion
tablets containing griseofulvin. European J PharmaSci 32, 2007, 58-68.
[8]. Shirsand SB, Sarasija S, Para MS, Swamy PV, Nagendra KD. PlantagoOvata Mucilage in the Design of Fast
Disintegrating Tablets. Indian J Pharm sci 2009, 41-4.
[9]. Areefulla HS, Mujaheed A, Raheem MA, Ayesha S, Bilguese F et al. Orodissolving tablets of Itopride
Hydrochloride prepared by sublimation technique. Indian J Pharm sci 71(2), 2009, 168.
[10]. Yadav R, Gupta RN, Yadav C. Formulation and In-Vitro evaluation of Orodispersible Dosage form of
Stavudine. Indian J Pharmsci 71(2), 2009, 163-4.
[11]. Nagendrakumar D, Raju SA, Shirsand SB, Para MS, Rampure MV et al. Fast dissolving Tablets of Granisetron
Hydrochloride using disintegrant blends for improved Efficacy.Indian J Pharm sci 71(2), 2009, 188.
[12]. Rao NGR, Patel T, Gandhi S. Development and evaluation of Carbamazepine Fast Dissolving Tablets Prepared
with a complex by direct compression technique. Asian J Pharm 3(2), 2009, 97-103.
[13].Patel H.A, Patel JK, Patel KN, Patel R.R. Formulation and In-vitro evaluation of fast dissolving tablets of
Domperidone. Int J Pharm Sci 2(1), 2010, 470-476.