This document summarizes the formulation and evaluation of fast dissolving tablet dosages of felodipine. It discusses the drug profile, aim/objectives of developing fast dissolving tablets, materials/equipment used, preparation of formulations using different superdisintegrants (crospovidone, crosscarmellose sodium, sodium starch glycolate), and evaluation of tablet properties (thickness, hardness, friability) and performance (disintegration time, dissolution). 9 formulations were developed and evaluated, with F3 showing the fastest disintegration time of 116 seconds and highest drug release of 90.58% within 30 minutes. The study demonstrated the potential of using superdisintegrants to develop fast dissolving felodipine tablets for improved patient compliance and
Formulation and evaluation of fast dissolving tabletsSURYAKANTVERMA2
The concept of mouth dissolving drug delivery systems (MDDDS) or fast dissolving tablets emerged with an objective to improve patient’s compliance.
These dosage forms rapidly disintegrate and/or dissolve to release the drug as soon as they come in contact with saliva, thus obviating the need for water during administration, an attribute that makes them highly attractive for pediatric and geriatric patients.
Formulation and evaluation of fast dissolving tabletsSURYAKANTVERMA2
The concept of mouth dissolving drug delivery systems (MDDDS) or fast dissolving tablets emerged with an objective to improve patient’s compliance.
These dosage forms rapidly disintegrate and/or dissolve to release the drug as soon as they come in contact with saliva, thus obviating the need for water during administration, an attribute that makes them highly attractive for pediatric and geriatric patients.
Superdisintegrants in Orally Administered Products of Pharmaceuticals A Reviewijtsrd
Superdisintegrants are developed to improve the palatability in orally administered products and to advancing the development of various formulations with increase performance and acceptability. Superdisintegrants are used to revise the potency of solid dosage form .This is accomplish by decreasing the disintegration time which in turn improvement the drug dissolution rate. Diverse categories of Superdisintegrants such as synthetic, semi synthetic, natural and cross processed blend etc. The present study comprises the various kinds of Superdisintegrants which are being used in formulations to provide the safer effective drug delivery with patient’s compliance. Snehal N. Dhoot | Sharda P. Shahane | Kiran. P. Gaikwad | Leena P. Joge | Jaya P. Ambhore "Superdisintegrants in Orally Administered Products of Pharmaceuticals: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50282.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50282/superdisintegrants-in-orally-administered-products-of-pharmaceuticals-a-review/snehal-n-dhoot
The Metformin HCL Gastroretentive Floating Sustained released Tablet is formulated by the Wet Granulation technique. This Tablet is containing both Effervescent as well as Non Effervescent system. The HPMC K 100 Swellable polymer is responsible for the Floating. (Non Effervescent system) and The Sodium Bicarbonate is responsible for
the effervescent system. A combination of HPMC K 100 and Xanthum Gum shows better sustained release activity. The Prepared Gastroretentive Floating Sustained released Tablet is Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index and, weight variation test, friability test and in vitro study, Total Floating Time. The result associated in Optimized batch is good to Satisfactory and having a good free flowing property. The weight variation and friability these values are within the pharmacopeia limit. The in vitro Dissolution studies shows Maximum percentage of release of drug (99.25) with in end of 8 Hours.
Formulation and evaluation of transdermal drug delivery system (TDDS)SanketPawar47
This is slide about formulation and evaluations of transdermal drugs delivery system . Introduction , general structure of TDDS , basic components of TDDS , approch for formulation of TDDS , manufacturing processes for TDDS ,and evaluations of TDDS
pharmaceutical technologists have developed a novel oral dosage form known as orally disintegrating tablets (odts) which disintegrate rapidly in saliva, usually in a matter of seconds, without the need to take it water. drug dissolution and absorption as well as onset of clinical effect and drug bioavailability may be significantly greater than those observed from conventional dosage forms ,
Solid dispersion is an effective way of improving the dissolution rate of poorly water soluble drugs and hence its bioavailability. The water soluble carriers used in preparation of solid dispersion enhance the dissolution rate of the poorly water soluble drug. This work reflects the improvement of Dissolution Characteristics as well as Bioavailability of poorly aqueous soluble drug Hydrochlorothiazide. It belongs to BCS class 2 i.e. it has poor water solubility but good permeability.
Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
Superdisintegrants in Orally Administered Products of Pharmaceuticals A Reviewijtsrd
Superdisintegrants are developed to improve the palatability in orally administered products and to advancing the development of various formulations with increase performance and acceptability. Superdisintegrants are used to revise the potency of solid dosage form .This is accomplish by decreasing the disintegration time which in turn improvement the drug dissolution rate. Diverse categories of Superdisintegrants such as synthetic, semi synthetic, natural and cross processed blend etc. The present study comprises the various kinds of Superdisintegrants which are being used in formulations to provide the safer effective drug delivery with patient’s compliance. Snehal N. Dhoot | Sharda P. Shahane | Kiran. P. Gaikwad | Leena P. Joge | Jaya P. Ambhore "Superdisintegrants in Orally Administered Products of Pharmaceuticals: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50282.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50282/superdisintegrants-in-orally-administered-products-of-pharmaceuticals-a-review/snehal-n-dhoot
The Metformin HCL Gastroretentive Floating Sustained released Tablet is formulated by the Wet Granulation technique. This Tablet is containing both Effervescent as well as Non Effervescent system. The HPMC K 100 Swellable polymer is responsible for the Floating. (Non Effervescent system) and The Sodium Bicarbonate is responsible for
the effervescent system. A combination of HPMC K 100 and Xanthum Gum shows better sustained release activity. The Prepared Gastroretentive Floating Sustained released Tablet is Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index and, weight variation test, friability test and in vitro study, Total Floating Time. The result associated in Optimized batch is good to Satisfactory and having a good free flowing property. The weight variation and friability these values are within the pharmacopeia limit. The in vitro Dissolution studies shows Maximum percentage of release of drug (99.25) with in end of 8 Hours.
Formulation and evaluation of transdermal drug delivery system (TDDS)SanketPawar47
This is slide about formulation and evaluations of transdermal drugs delivery system . Introduction , general structure of TDDS , basic components of TDDS , approch for formulation of TDDS , manufacturing processes for TDDS ,and evaluations of TDDS
pharmaceutical technologists have developed a novel oral dosage form known as orally disintegrating tablets (odts) which disintegrate rapidly in saliva, usually in a matter of seconds, without the need to take it water. drug dissolution and absorption as well as onset of clinical effect and drug bioavailability may be significantly greater than those observed from conventional dosage forms ,
Solid dispersion is an effective way of improving the dissolution rate of poorly water soluble drugs and hence its bioavailability. The water soluble carriers used in preparation of solid dispersion enhance the dissolution rate of the poorly water soluble drug. This work reflects the improvement of Dissolution Characteristics as well as Bioavailability of poorly aqueous soluble drug Hydrochlorothiazide. It belongs to BCS class 2 i.e. it has poor water solubility but good permeability.
Gastro retentive drug delivery system (GRDDS)Shweta Nehate
Oral route is the most acceptable route for drug administration. Apart from conventional dosage forms several other forms were developed in order to enhance the drug delivery for prolonged time period and for delivering drug to a particular target site. Gastro-retentive drug delivery system (GRDDS) has gainned immense popularity in the field of oral drug delivery recently. it is a widely employed approach to retain the dosage form in the stomach for an extended period of time and release the drug slowly that can address many challenges associated with conventional oral delivery, including poor bioavailability. different innovative approaches are being applied to fabricate GRDDS. Gastroretentive drug delivery is an approach to prolong gastric residence time, there by targeting site-specific drugs release in the upper gastrointestinal tract (GIT) for local or systemic effects. It is obtained by retaining dosage form into stomach and by releasing the in controlled manner.
Development and Characterisation of Fast Dissolving Oral FilmsPardeep Jangra
For My review article on Fast Dissolving Oral Films, click on this link http://www.ijupbs.com/Uploads/2.%20RPA13140283015.pdf or copy paste this link in browser.
Pardeep Kumar Jangra
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.
Formulation Development and Evaluation of Mouth Dissolving Film of Ziprasidon...ijtsrd
The primary objective of this work was to develop a mouth dissolving film with Ziprasidone HCI, along with bioenhancer quercetin and basic ingredients like polymers, plasticizers, sweetener, saliva stimulating agent and flavor. The films were prepared by solvent casting I method. Quercetin enhances dissolution of drug which results in increase in CDR upto 99 . HPMC E5 cps, which was not able to impart thickness to the film, HPMC E15 shown good flexibility. The plasticizer propylene glycol which was not able to impart flexibility and folding endurance to the film. PEG 400 produced good folding endurance, tensile strength and percent elongation. The optimized formulation F3 was shown good mouth feel, folding endurance, instant drug release as well as good mechanical properties. The F3, shown less disintegration time of 31 seconds and 95 drug released within 3 minutes. Therefore it was concluded that rapid drug release was achieved for immediate onset of action using quercetin as natural bioenhancer which is beneficial and gives maximum drug release when compared to conventional dosage form. Jaydeep Jadhav "Formulation Development and Evaluation of Mouth Dissolving Film of Ziprasidone Using Natural Bioenhancer" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50464.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50464/formulation-development-and-evaluation-of-mouth-dissolving-film-of-ziprasidone-using-natural-bioenhancer/jaydeep-jadhav
Formulation and Evaluation of Amlodipine Fast Dissolving Tabletsijtsrd
Fast dissolving tablet is a new era for successful development of controlled release formulation along with various features to provide successful drug delivery. In the present study, an attempt was made to design and evaluate fast dissolving tablets of Amlodipine besylate, which is used commonly for the treatment of angina pectoris. The tablets were prepared by direct compression method followed by sublimation method using super disintegrants sodium starch glycolate, crosspovidone and croscarmellose sodium. The prepared powder blends were evaluated for preformulation parameters. The tablets were evaluated for thickness, hardness, weight variation, drug content uniformity, friability and in vitro drug release studies. In vitro drug release studies were performed by using USP type II apparatus paddle method at 50 rpm in 900 ml of 0.1N HCl as dissolution medium for 30 minutes at 37±0.5°C. The formulation F9 containing Croscarmellose sodium 7 showed better disintegration and dissolution up to 30 minutes. Hence, formulation F9 was considered as optimized formulation which showed the best drug release profile up to 30 minutes. The results of mathematical model fitting of data obtained indicated that, the best fit model in all the cases the release was found to be by diffusion and fickian release. The results of FTIR analysis showed that there was no physical and chemical interaction between drug and other excipients. The study indicates that the fast dissolving tablets of Amlodipine besylate can effectively reduce the adverse effects and frequency of administration of the drug. Aparna. P | Dr. Subash Chandran M. P | Remya S B "Formulation and Evaluation of Amlodipine Fast Dissolving Tablets" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29563.pdfPaper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/29563/formulation-and-evaluation-of-amlodipine-fast-dissolving-tablets/aparna-p
Formulation and Evaluation of Floating Tablet of Metoprolol Succinateijtsrd
The aim of the present work is Formulation and Evaluation of Floating Tablet of Metoprolol Succinate. Metoprolol Succinate is a BCS class I drug used in the treatment of Angina pectoric, Heart attack, Hypertension and has short half life 3 7hours. In the present study it was planned to prepare sustained release floating tablets of Metoprolol succinate by using HPMC E5 and Gum Karaya excipients. The procured sample of drug was authenticated by pre formulation study like melting point, IR spectra, UV analysis were done. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Prior to compression, the powder blend were evaluated for angle of repose, bulk density, tapped density, compressibility index, Hausners ratio. Results of pre formulation studies show that Metoprolol Succinate was pure and complies with standard. Formulations were evaluated for various evaluation parameters like hardness, thickness, weight variation, friability, drug content, floating lag time, floating time, swelling index and in vitro drug release. From the results of evaluation parameters it was observed that formulation F6 shows best results for floating lag time 4min floating time up to 12 hours and consistent drug release 96.15 as compared to other formulations. So formulation F6 was finalized as a optimized formulation for further study. On the basic of above finding it was concluded that sustained release floating drug delivery system was successfully achieved. Neeta. V. Jadhav | Prof. Mr. Prashant Khade | Dr. Ashok Bhosale "Formulation and Evaluation of Floating Tablet of Metoprolol Succinate" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50409.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50409/formulation-and-evaluation-of-floating-tablet-of-metoprolol-succinate/neeta-v-jadhav
The oral route is the most favorable route for administration of drugs because of accurate dosage, low cost of therapy, self medication, non-invasive method, and ease of administration leading to a high level of patient compliance. Of the oral Dosage forms, solid dosage form is the preferred class of product as tablet represents a unit dosage form in which one dose of drug is placed accurately.
Polysaccharide Based Drug Delivery System for Periodontitis-PPT.pptxVasundharaPatil12
Project aimed to develop a biocompatible In-situ gel for reducing inflammation caused due to Periodontitis and enhancing bioavailability of drug. Developed a biocompatible in-situ gel utilizing Tamarind Seed Polysaccharide (TSP) as the primary material and natural polymer.
Focused on enhancing gel adhesion to Periodontal tissues, reducing inflammation, and swelling associated with Periodontitis.
Conducted in-vitro studies to evaluate the effectiveness of the drug delivery system.
Demonstrated a 65% improvement in targeted drug delivery, indicating the efficacy of the developed formulation.
Mouth dissolving tablets- A unique dosage form curtailed for special purpose:...IOSR Journals
The concept of mouth dissolving tablets known as MDTs has emerged with an objective to improve patient’s compliance. Methods to improve patient’s compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, mouth dissolving drug delivery systems (MDDDS) have obtained an important position in the market by overcoming previously encountered administration problems and contributing to extension of patent life. These dosage forms rapidly disintegrate in contact with saliva even within <60 seconds, an attribute that makes them highly attractive for paediatric, geriatric, bedridden patients and for active patients who are busy and in travelling may not have access to water. This special dosage form has some prerequisite criteria for formulation and this also involves the use of special techniques for large scale industrial production. The aim of this article is to review the advantages and disadvantages of MDTs, common excipients used in the formulation especially highlighting the use of superdisintegrating agents and taste masking agents in formulation and finally the popular methods used to produce large scale tablets for commercial purpose.
ABSTRACT
The aim of the present research work was to enhance the solubility of
Carvedilol by solid dispersion method and to formulate a mouth
dissolving tablet. Drugs are more frequently taken by oral
administration. The solubility of Carvedilol enhanced with different
ratios of PVP by the solvent evaporation method .In-vitro release
profile of solid dispersion obtained in SGF without enzymes and Ph
6.8 phosphate buffer indicate that 100% drug release found within 20
min. These solid dispersion were directly compressed into tablets using
Crospovidone, sodium starch glycol ate, croscarmellose sodium and
polyacrylic potassium in different concentrations as a super
disintegrants. The prepared tablets containing the solid dispersion of
Carvedilol having sufficient strength of 2.5-4 kg/cm2. The
disintegrated in the oral cavity with in 21 sec. contain Crospovidone
(5%) as super disintegrant.
KEYWORDS: Carvedilol, PVP, Super Disintegrants, Mouth Dissolving Tablet.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
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http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Palestine last event orientationfvgnh .pptxRaedMohamed3
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How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
2. Introduction.
Review of literature.
Drug profile.
Excipients.
Aim & objectives.
Plan of work.
Materials & Equipments
Experimental work.
Result & Discussion.
Conclusion.
References.
CONTENTS :
3. US FDA defined ODT as “A solid dosage form
containing medicinal substances which disintegrates rapidly
usually within a matter of seconds, when placed upon the tongue”.
Recently, ODT have started gaining popularity and acceptance
as new drug delivery systems, because they are easy to administer
and better patient compliance, especially in elderly and children.
Orodispersible tablets are also known as Mouth dissolving
tablets, Orally disintegrating tablets, Melt in mouth, Fast‐ ‐
dissolving drug delivery, Rapimelts tablets, Porous tablets, Quick
dissolving tablets etc.
Defination :
4. Orodispersible tablets (ODT) are oral solid dosage forms that
disintegrate in the oral cavity in easy swallow residue.
faster the drug goes into solution, quicker the absorption and onset
of clinical effect, as the saliva passes down into the stomach. In such
cases, bioavailability of drug is significantly greater than those
observed from conventional tablets dosage form.
Recently ODT terminology has been approved by United States
Pharmacopoeia, British Pharmacopoeia and Centre for Drug
Evaluation and Research (CDER).
5. Advantages of fast dissolving drug delivery system
Ease administration for patients who are mentally ill, disabled
and uncooperative.
No water needed.
Can be designed to leave minimal or no residue in mouth
It provide a pleasant mouth feel.
No chewing needed.
Better taste obtained by taste masking.
Improved stability, low sensitivity to environmental condition
6. Disadvantage of Mouth Dissolving Tablets:
Drugs with relatively larger doses are difficult to formulate into
FDT e.g. antibiotics
Patients who concurrently take anticholinergic medications may
not be the best candidates for FDT.
patients with Sjogren's syndrome or dryness of the mouth due
to decreased saliva production may not be good candidates for
these tablet formulations.
7. Need to formulate fast dissolving tablets
Geriatric patients mainly suffering from conditions like
hand tremors and dysphasia.
Pediatric patients who are unable to swallow easily because
their central nervous system and internal muscles are not
developed completely.
Traveling patients suffering from BP and angina pectoris
that do not have easy access to water.
Mentally challenged patients, bedridden patients and
psychiatric patients.
8. The ideal characteristics of a drug for fast dissolving tablet
1. Ability to permeate the oral mucosa.
2. Have the ability to diffuse and partition into the epithelium
of the upper GIT.
3. Small to moderate molecular weight.
4. Low dose drugs preferably less than 50 mg.
5. Short half life and frequent dosing drugs are unsuitable for
ODT.
6. Very bitter or unacceptable taste and odour drugs are
unsuitable for ODT.
9. TECHNIQUES FOR SOLUBILITY ENHANCEMENT
Inclusion Complex Formation Techniques
Grinding method:
Drug and carriers were blended in desired proportions using
spatula for 10 minutes and then ground in mortar with pestle. The
co-grinding mixture was then passed through sieve #40 and stored
in desiccator until further use.
eg. Cyclodextrine
Advantages of cyclodextrin complexes
It improves bioavailability from solid formulations.
Stability and shelf life can be increased.
Gastrointestinal irritation may be reduced.
Complexation prevents drug-drug or drug-additive interaction.
It can be used to mask unpleasant odor and taste.
10. 2. REVIEW OF LITERATURE:-
1) Vikas Agarwal et al: Encyclopedia of pharmaceutical
technology, Third edition,
Volume 2;stated that A large number of companies are in the ODT
drug.As pharmaceutical companies are now starting to recognize the
need for more technological advances to meet the new challenges in
the future, DDT continues to have a significant impact and
contribution in meeting those demands and challenges.
2)Abu-Izza et al: Patent on Fast dissolving tablet; shows the
present invention relate to the process for preparation of tablet
which dissolve rapidly in the mouth and provide an excellent
mouthfeel. The tablet of the invention comprise a compound which
melt at about 370
C.or lower, have a low hardness, high stability and
generally comprise a few insoluble disintegrant which may cause a
gritty or chalky sensation in the mouth
11. Convenient and economically feasible processes by which the tablet
of the invention may be produced are also provided.(United States
Patent, Patent No. US 6,733,781 B2)
.
3) Jain et al: Patent on Rapidly disintegrating solid dosage
form; stated that the rapidly disintegrating solid dosage form of
poorly soluble active ingredient and at least one pharmaceutically
acceptable water- soluble or water-dispersible excipient, where in
poorly soluble active ingredient particles have an average
diameter, prior to inclusion in the dosage form, of less than about
2000nm.the dosage form of the invention has the advantage of
combining rapid presentation and rapid dissolution of the active
ingredient in oral cavity(.(United States Patent, Patent No. US
6,316,029 B1)
4) Sahu Chandra Mohan et al: Recent advances in orodispersible
tablets: A Review; studied on The techniques and technologies
described in this article represent how recent advances in formulation
development and processing technologies make the efforts to achieve
orodispersible tablets, conclude that the basic approach followed by all
13. 13
Molecular weight : 384.25
Description : Slightly yellowish & Crystalline powder.
Solubility : It is insoluble in water & freely soluble in ethanol &
dichloromethane.
Melting point : 142-1450
c
Dose : 5mg ones a day
Bioavailibility : 15%
Absorption : Completely absorbed from g.i.t
Metabolism : Metabolised in gut & liver.
15. AIM :
Formulation of fast dissolving tablet and evaluate them to
get optimized result.
OBJECTIVES :
1.For rapid dissolution of drug and absorption which may produce
rapid onset of action.
2. To avoid first pass metabolism
3.To Improved patient compliance.
4. It can be designed to leave minimal or no residue in mouth .
5. To improved biopharmaceutical properties and better safety
compared with conventional oral dosage forms.
16. PLAN OF WORK:
1. Literature survey.
2. Procurment of drug, polymer & other excipients
for the study.
3. Selection of material of required standard &
qualitative analysis of raw material
4. Pre-formulation studies.
5. Preparation of various formulae for study.
17. 6) Evaluation of tablet.
a)Tablet appearance.
b)Thickness.
c)Diameter.
d)Hardness.
e)Friability.
f)Weight variation.
g)Assay of tablet.
h)Disintegration study
i)Dissolution study
18. Sr. no Ingredients Grade Suppliers
1 Felodipine Pharma
Ajanta pharma
Ltd,Mumbai
2
Cross carmellose sodium
Pharma FDC Ltd, Mumbai
3 Crosspovidone Pharma
Leben Laboratories
Pvt. Akola
4 Sodium starch glycolate Pharma
Leben Laboratories
Pvt. Akola
5 Microcrystalline cellulose Pharma
Leben Laboratories
Pvt. Akola
6 Magnesium stearate Pharma
Leben Laboratories
Pvt. Akola
7 Talc Pharma
Leben Laboratories
Pvt. Akola
8 Mannitol AR Rajesh chemicals
Materials & Equipments
Table : List of Excipients
19. Sr.
No
Instruments Manufacturer
1 Electronic Balance Dolphin,Mumbai.
2 Tablet compression machine Cadmach, Ahemadabad.
3 Electronic balance Dolphin,Mumbai.
4 Friability Test Apparatus Roche Friabilator
5 Vernier Caliper Mitutoyo,Japan
6 Tablet Dissolution Tester
Electro Lab.(USP XX III) (DTD-
06P)
7 Ultra violet Spectrophotometer
UVvisible Double Beam, Elico.
(SL218).
8 Fourier Transform Infra Red
IR affinity-1,FTIR-
8001:Shimadzu,Japan
9 Digital pH meter Equip-Tronics,EQ-610.
10 Hot Air Oven
Shreeji pharmaceuticals,scientific
lab Mumbai,India.
Table: List of Equipments
Equipments
20. EXPERIMENTAL WORK :
SPECTRAL ANALYSIS OF FELODIPINE
Differential Scanning Colorimery
DRUG –POLYMER INTERACTONS
Fourier transform infrared spectroscopy
PREPARATION OF BUFFERS AND REAGENTS
1 Sodium hydroxide solution (0.1 N)
2 Monobasic sodium phosphate monohydrate(1 M)
3 Dibasic sodium Phosphate anhydrous(0.5M)
4 Phosphate buffer solution (pH 6.5)
21. FTIR Spectra of Felodipine
DSC of Felodipine
FTIR spectra of Felodipine physical mixture.
23. Standard Calibration Curve In phosphate buffer pH 6.5
Concentration(µg/
ml)
Absorbance
0 0
10 0.09
20 0.1811
30 0.2737
40 0.3448
50 0.4235
Table : Conc. And absorbance
From the standard curve of Felidipine, it was observed that the drug obeys
beer’s law in concentration range of 10 to 50 µg/ml against absorbance at
312 nm. in 6.5 phosphate buffer. The linear regression equation generated
was used for the calculation of amount of drug release. The value of R2
is
0.997.
24. FORMULATION DESIGN
Direct Compression Method
Sr.No Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9
1 FD+β-CDN complex 10 10 10 10 10 10 10 10 10
2 CP 3 6 9 - - - - - -
3 CCS - - - 3 6 9 - - -
4 SSG - - - - - - 3 6 9
5 Avicel pH101 10 10 10 10 10 10 10 10 10
6 Talc 6 6 6 6 6 6 6 6 6
7 Mg.streate 2 2 2 2 2 2 2 2 2
8 Mannitol 89 86 83 89 86 83 89 86 83
Total 120 120 120 120 120 120 120 120 120
Table : Composition of Fast dissolving tablet formulation containing Felodipine
The ingredients used in the manufacture of tablets for the batches F1 to
F9 are shown in the Table
*FD-Felodipine,*CP-crospovidone,*CCS-crosscarmellose sodium,*SSG-sodium starch glycolate
25. Physical properties
Bulk density.
Tapped density.
Carr´s Compressibility index.
Hausner’s ratio.
Angle of repose.
Table : Physical properties of the powder-blends of the batches F1 to F3
Parameter F1 F2 F3
Bulk density (gm/cc)
Tapped density (gm/cc)
Angle of repose,
Compressibility index (%)
Hausner’s ratio
0.57
0.68
43.15
16.17
1.19
0.47
0.73
41.81
35.61
1.55
0.54
0.72
28.60
18.51
1.29
26. Parameter F4 F5 F6
Bulk density (gm/cc)
Tapped density (gm/cc)
Angle of repose,
Compressibility index (%)
Hausner’s ratio
0.58
0.78
27.34
10.00
1.34
0.56
0.78
40.10
28.20
1.39
0.58
0.77
48.23
24.67
1.32
Table : Physical properties of the powder-blends of the batches F4 to F6
Parameter F7 F8 F9
Bulk density (gm/cc)
Tapped density (gm/cc)
Angle of repose,
Compressibility index (%)
Hausner’s ratio
0.58
0.70
26.56
17.14
1.20
0.61
0.72
32.46
15.20
1.18
0.59
0.70
36.32
15.71
1.18
Table : Physical properties of the powder-blends of the batches F7 to F9
27. 1. Thickness.
2. Diameter.
3. Hardness.
4. Friability.
5. Weight variation.
6. Assay of tablet.
7. Disintegration study
8. Dissolution study
Evaluation parameter of
tablet.
28. Sr.No. Parameters F1 F2 F3
1. Thickness (mm 2.5 2.6 2.5
2 Diameter (mm) 6 6 6.1
3 Hardness (kg/cm2. ) 2.86 3.3 2.8
4 Friability (%) 0.81 0.40 0.48
5 Uniformity of weight (mg) 121±10% 116±10 121±10
6 Drug content (%) 96.35 95.87 99.20
7 Disintegration time(sec) 137 129 116
Table: Post compression parameter of fast dissolving tablets for the batches F1 to F3
Sr.No. Parameters F4 F5 F6
1 Thickness (mm) 2.9 2.8 2.7
2 Diameter (mm) 6.1 6 6
3 Hardness (kg/cm2) 3.6 3.8 2.6
4 Friability (%) 0.97 0.48 0.97
5 Uniformity of weight (mg) 122±10 122 ±10 127±10
6 Drug content (%) 96.72 94.5 92.26
7 Disintegration time(Sec) 140 132 126
Table : Post compression parameter of fast dissolving tablets for the batches F4 to
F6
29. Sr. No. Parameters F7 F8 F9
1 Thickness (mm) 2.6 2.6 2.6
2 Diameter (mm) 6.1 6 6.1
3 Hardness (kg/cm2. 4.2 3.5 3.7
4 Friability (%) 1.1 0.40 0.88
5 Uniformity of weight (mg) 125±10 122±10 124±10
6 Drug content (%) 96.72 94.74 97.03
7 Disintegration time(Sec) 138 141 134
Table : Post compression parameter of fast dissolving tablets for the batches F7 to F9
30. Sr.No. Time (Min) % Drug Release
F1 F2 F3
1 1 38.55 15.72 18.28
2 3 54.55 24.60 28.6
3 5 72.47 33.90 39.42
4 10 76.89 52.81 61.41
5 15 73.09 66.60 77.89
6 30 89.07 77.89 90.58
7 45 94.92 84.44 98.18
0
20
40
60
80
100
120
0 10 20 30 40 50
F1
F2
F3
Time(min)
%DrugRelease
Comparative dissolution profile of F1, F2,F3
Table : In vitro release of felodipine from tablets for the batches F-1 to F-3
Figure : In vitro release of felodipine from the tablets for the batches F1, F2 and F3.
31. Sr.No. Time (Min) % Drug Release
F4 F5 F6
1 1 24.42 36.87 39.64
2 3 28.60 40.48 39.64
3 5 31.65 46.69 54.20
4 10 43.20 53.02 57.08
5 15 51.42 66.39 64.16
6 30 66.93 78.95 80.64
7 45 81.19 88.63 93.76
0
10
20
30
40
50
60
70
80
90
100
0 10 20 30 40 50
F4
F5
F6
Time (Min)
Comparative dissolution profile of F4, F5,F6
%DrugRelease
Figure: In vitro release of felodipine from the tablets for the batches F4, F5 and F6.
Table : In vitro release of felodipine from tablets for the batches F-4 to F-6
32. Sr. No. Time (Min) % Drug Release
F7 F8 F9
1 1 19.75 24.75 28.33
2 3 26.98 30.11 35.19
3 5 37.13 36.70 41.10
4 10 50.35 48.75 48.75
5 15 53.86 63.41 61.93
6 30 70.3 76.73 78.95
7 45 80.14 88.21 92.09
Figure : In vitro release of felodipine from the tablets for the batches F7, F8 and F9
Table : In vitro release of felodipine from tablets for the batches F-7 to F-9
33. 1. Suitable analytical method based on UV-Visible
spectrophotometer was developed for felodipine. λmax of 312.2
nm was identified in methanol and 311 nm in phosphate buffer
solution, pH 6.5.
2. From the FT-IR spectra the interference was verified and found
that felodipine did not interfere with the excipients used.
3. Direct compression method was established to manufacture fast
dissolving tablets of felodipine.
4. Fast dissolving tablets of felodipine were successfully prepared
using croscarmellose sodium, sodium starch glycolate,
crospovidone.
SUMMARY AND CONCLUSION
SUMMARY
34. 5. In the present study, fast dissolving tablets were prepared
using single superdisintegrant in each formulation
6. Evaluation parameters like hardness, friability, weight
variation and drug content indicate that values were within
permissible limit for all formulations.
7. In vitro drug release study was carried out and based on the
results; F-3 was identified as the best formulation among all
the other formulations and In vitro release profiles was more
than 98% within 45 minutes.
8. The formulation F-3 contains croscarmelose a polymer
which causes the disintegration by capillary action. It causes
the in vitro dispersion within 45 min.
and hence the formulation F3 was optimized after conducting
the reproducibility study.
35. CONCLUSION
The conclusions arrived in this thesis indicated that the Fast dissolving
tablet of felodipine developed in this investigation releases drug
batter than conventional tablet drug release, based on in vitro release
studies. Further studies are needed to investigate these formulations
for its performance in vivo.
Thus the objectives of the present thesis are achieved.
The result of the study indicates that fast dissolving tablet of felodipine
that can be successfully prepared.
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