This document describes the formulation, optimization, and evaluation of liquisolid tablets containing tadalafil to improve its bioavailability. Tadalafil was selected as a model drug due to its low water solubility. Several liquisolid formulations were prepared containing different ratios of carrier to coating materials in the powder substrate and a fixed liquid medication. The dissolution profiles of the liquisolid tablets were determined and compared to a commercial product. Prepared liquisolid tablets showed enhanced dissolution profiles compared to the commercial product, indicating improved bioavailability. The optimized formulation exhibited consistent performance over stability testing. Overall, the liquisolid technique improved the dissolution and predicted bioavailability of tadalafil tablets.
Development and Validation of Stability Indicating Assay Method of Montelukas...ijtsrd
Background A simple, precise cost effective stability indicating assay method of Montelukast by RP HPLC. Material Chromatographic separation was achieved on a Meteoric core C18 column 100mm x 4.6 mm, 2.7µm using a mobile phase 2 ml Trifluroacetic acid mixture of acetonitrile 250ml and methanol 400ml 350 650 at a flow rate of 1.5ml per minute. Wavelength was detection at 255nm. The retention time of Montelukast was 4 minutes. Results The method was found linear concentration the range of 120.39 802.57µg ml, tablet analysis of RSD 0.403, accuracy range 30 , 50 , 100 , and 200 , Precision RSD 0.3. The proposed method was validated as per the ICH guidelines. Conclusion The HPLC method was validated and demonstrated good linearity, precision, accuracy, specificity, robustness and stability indicating. The development HPLC method can be utilized for routine analysis stability studies for Montelukast. Miss. Harshada Ravindra Patil | Mr. Pavan Nathu Patil "Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC" 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/ijtsrd29809.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/29809/development-and-validation-of-stability-indicating-assay-method-of-montelukast-tablet-by-rp-hplc/miss-harshada-ravindra-patil
Preparation, In Vitro and In Vivo Characterization of Solid Dispersions of La...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
Development and Validation of Stability Indicating Assay Method of Montelukas...ijtsrd
Background A simple, precise cost effective stability indicating assay method of Montelukast by RP HPLC. Material Chromatographic separation was achieved on a Meteoric core C18 column 100mm x 4.6 mm, 2.7µm using a mobile phase 2 ml Trifluroacetic acid mixture of acetonitrile 250ml and methanol 400ml 350 650 at a flow rate of 1.5ml per minute. Wavelength was detection at 255nm. The retention time of Montelukast was 4 minutes. Results The method was found linear concentration the range of 120.39 802.57µg ml, tablet analysis of RSD 0.403, accuracy range 30 , 50 , 100 , and 200 , Precision RSD 0.3. The proposed method was validated as per the ICH guidelines. Conclusion The HPLC method was validated and demonstrated good linearity, precision, accuracy, specificity, robustness and stability indicating. The development HPLC method can be utilized for routine analysis stability studies for Montelukast. Miss. Harshada Ravindra Patil | Mr. Pavan Nathu Patil "Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC" 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/ijtsrd29809.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/29809/development-and-validation-of-stability-indicating-assay-method-of-montelukast-tablet-by-rp-hplc/miss-harshada-ravindra-patil
Preparation, In Vitro and In Vivo Characterization of Solid Dispersions of La...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
The role of dissolution in the demonstration of bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
Evaluation methods for drug excipients and container interactionSagar Savale
Excipients are one of the three components that in combination produce the medicine that the patient will take.
In therapeutic terms, the API is of primary importance because without it there is no treatment and no product.
In term of drug manufacturing all three of them are equally important so we cannot neglect anyone of them.
The interactions between excipients and the other two components (the API and the manufacturing process), and/or between two or more excipients, are fundamental to the transformation of an API into a medicinal product.
Spectrophotometric Estimation of Rosuvastatin Calcium in Bulk and Pharmaceuti...SriramNagarajan15
Rosuvastatin calcium of the class statins is used for primary hyperlipidemias. It is a selective and competitive inhibitor of HMG-CoA reductase. In the present work, simple, sensitive and economic spectrophotometric method has been developed for quantitative determination of Rosuvastatin calcium. In the present spectrophotometric method Rosuvastatin calcium was dissolved in double distilled water. It exhibited an absorption maximum at 241 nm and obeyed Beer’s law in the concentration range of 5-25g/ml. The results of analysis have been validated and found to be sensitive, precise and accurate for quantitative determination of Rosuvastatin calcium in bulk drug and pharmaceutical formulations.
Development, Characterization, and Isolation of Alkaloidal Fraction from Teph...BRNSS Publication Hub
A wound is a break in the skin. Wound is usually caused by cuts or scalps, and symptoms at wound or injury include swelling, stiffness, tenderness, discoloration skin tightness, itching, and scar formation, two types of tissue injury. Wound healing is a complex dynamic process. The main objective of this investigation is to study the development, characterization, and isolation of alkaloidal fraction from Tephrosia purpurea and evaluate its wound healing activity in various wound models such as excision, incision, dead space, and burn wound models. Various evaluation parameters such as wound contraction, epithelization time, tensile strength, wet and dry granuloma weight, and hydroxyproline estimation were performed. The main objective of this investigation is to develop a product, which may give a wound healing property, and enhance wound healing process such as increase the collagen synthesis, fibroblast proliferation, angiogenesis, and epithelization because products which are available in market are either antiseptic or antimicrobial.
Ultra performance liquid chromatographic method for simultaneous quantificati...Ratnakaram Venkata Nadh
Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes
(non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main
objective of the current study was to develop a short reverse phase chromatographic
method for the simultaneous quantification of PLX and its impurities, in an injection
formulation, to reduce the time required for these quality tests. Furthermore, the
present work describes the role of nonalkyl branched nonquaternary ion pair reagent
in improving the peak shape and reducing column equilibration time. The separation
of PLX and its related substances is pH dependent (optimum pH = 2.50) and was
achieved on an octadecylsilyl (C18) column. The method was validated for its intended
purpose in accordance with the current regulatory guidelines for validation. The
proposed method can be applied for quality control, release, and stability analyses of
active pharmaceutical ingredient, PLX, as well as finished products, PLX injections
The role of dissolution in the demonstration of bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
Evaluation methods for drug excipients and container interactionSagar Savale
Excipients are one of the three components that in combination produce the medicine that the patient will take.
In therapeutic terms, the API is of primary importance because without it there is no treatment and no product.
In term of drug manufacturing all three of them are equally important so we cannot neglect anyone of them.
The interactions between excipients and the other two components (the API and the manufacturing process), and/or between two or more excipients, are fundamental to the transformation of an API into a medicinal product.
Spectrophotometric Estimation of Rosuvastatin Calcium in Bulk and Pharmaceuti...SriramNagarajan15
Rosuvastatin calcium of the class statins is used for primary hyperlipidemias. It is a selective and competitive inhibitor of HMG-CoA reductase. In the present work, simple, sensitive and economic spectrophotometric method has been developed for quantitative determination of Rosuvastatin calcium. In the present spectrophotometric method Rosuvastatin calcium was dissolved in double distilled water. It exhibited an absorption maximum at 241 nm and obeyed Beer’s law in the concentration range of 5-25g/ml. The results of analysis have been validated and found to be sensitive, precise and accurate for quantitative determination of Rosuvastatin calcium in bulk drug and pharmaceutical formulations.
Development, Characterization, and Isolation of Alkaloidal Fraction from Teph...BRNSS Publication Hub
A wound is a break in the skin. Wound is usually caused by cuts or scalps, and symptoms at wound or injury include swelling, stiffness, tenderness, discoloration skin tightness, itching, and scar formation, two types of tissue injury. Wound healing is a complex dynamic process. The main objective of this investigation is to study the development, characterization, and isolation of alkaloidal fraction from Tephrosia purpurea and evaluate its wound healing activity in various wound models such as excision, incision, dead space, and burn wound models. Various evaluation parameters such as wound contraction, epithelization time, tensile strength, wet and dry granuloma weight, and hydroxyproline estimation were performed. The main objective of this investigation is to develop a product, which may give a wound healing property, and enhance wound healing process such as increase the collagen synthesis, fibroblast proliferation, angiogenesis, and epithelization because products which are available in market are either antiseptic or antimicrobial.
Ultra performance liquid chromatographic method for simultaneous quantificati...Ratnakaram Venkata Nadh
Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes
(non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main
objective of the current study was to develop a short reverse phase chromatographic
method for the simultaneous quantification of PLX and its impurities, in an injection
formulation, to reduce the time required for these quality tests. Furthermore, the
present work describes the role of nonalkyl branched nonquaternary ion pair reagent
in improving the peak shape and reducing column equilibration time. The separation
of PLX and its related substances is pH dependent (optimum pH = 2.50) and was
achieved on an octadecylsilyl (C18) column. The method was validated for its intended
purpose in accordance with the current regulatory guidelines for validation. The
proposed method can be applied for quality control, release, and stability analyses of
active pharmaceutical ingredient, PLX, as well as finished products, PLX injections
Besoin de vous affirmer, de convaincre, d'inspirer et d'être inspirante alors venez passer une journée en petit groupe (pas + de 14 personnes) dans ma masterclass le 22 Mars prochain. Inscrivez vous vite.
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.
Method Development and Validation for Estimation of Oral Hypoglycaemic Drug D...ijtsrd
HPLC is a chromatographic technique employed in active compound chemistry and biochemistry to separate a mixture and substances with the goal of identifying, measuring, and purifying the different components of the mixture. Its a much better variety of column and traditional chromatography. The objective of the research work is to develop and validate a simple and accurate reverse phase chromatographic method to estimate amount of drug in dosage form. The developed method successfully can be applied to estimate the amount of Dapagliflozin in tablet dosage form. After oral administration of dapagliflozin, the maximum plasma concentration Concentration max under two hours. High performance liquid chromatographic system was alleviated according to the chromatographic settings. After attaining the steady base line, to verify the system suitability, a single 40 µg ml of standard solution proportional to 100 test concentration of dapagliflozin was injected into the HPLC system. The gradient mobile phase flow rate programming assisted in optimising the lengthy run duration and resolution of sample analysis, making the approach more cost effective and quick. Validation of the developed and optimized HPLC method was carried out according to ICH guidelines with respect to parameters such as linearity, specificity, precision and accuracy. Junaid Ahmed | Himanchal Sharma | Shiva Teotia "Method Development and Validation for Estimation of Oral Hypoglycaemic Drug Dapagliflozinina Tablet Dosage form by the Employment of Rp-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46395.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46395/method-development-and-validation-for-estimation-of-oral-hypoglycaemic-drug-dapagliflozinina-tablet-dosage-form-by-the-employment-of-rphplc/junaid-ahmed
Formulation and evaluation of gastroretentative floating sustained releasedme...Sagar Savale
The Metformin HCL Gastroretentative 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 Gastroretentative 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 show Maximum percentage of release of drug
(99.25) within end of 8 Hours.
Formulation and Evaluation of W/O/W Multiple Emulsions with Diclofenac SodiumSagar Savale
Multiple emulsion is novel approach of drug delivery system
for enhancement of bioavailability and pharmacological
activity. It is important to prevent the problem of oral drug
delivery system and they are stabilized by using of combination
of hydrophilic and lipophilic surfactant. The specific ratio of
surfactant concentration is responsible for maintaining the
stability of multiple emulsions, the importance of this study was
to prepare multiple emulsion of Diclofenac sodium by using
two step emulsification process, by using the non-ionic
surfactant units. In multiple emulsion, the stability of multiple
emulsion was evaluated, percent entrapment efficiency as well
as in vitro studies are conducted. The process of primary and
secondary emulsification was optimized to get the stable
multiple emulsion with the high entrapment efficiency. Multiple
emulsion to improve bioavailability with the hypothesis that
improvement of drug release profile will reflect the
enhancement of bioavailability of the drug.
Design and Development of Immediate and Sustained Release Tablets of Vildagl...Santosh Adhikari
Design and Development of Immediate and Sustained Release Tablets of
Vildagliptin.
Priyanka Shrestha1
*, Shiva Kumar Bhandari1
, SM Ashraful Islam1
, Md Selim Reza2
,
and Santosh Adhikari
3.
1
Department of Pharmacy, University of Asia Pacific, Dhanmondi, Dhaka-1209, Bangladesh
2
Department of Pharmaceutical Technology, University of Dhaka, Dhaka-1000, Bangladesh
3
Department of Pharmacy, Rajiv Gandhi University of Health Sciences, Banglore-560 041, Karnataka, India.
E2 design and development of immediate and sustained release tablets of vilda...Priyanka Shrestha
Research Journal of Pharmaceutical, Biological and Chemical Sciences
Design and Development of Immediate and Sustained Release Tablets of Vildagliptin.
Formulation and evaluation of gastroretentive ciprofloxacin hcl effervescent ...Sagar Savale
Ciprofloxacin HCL is an effervescent Tablet is made by Wet Granulation Method. Ciprofloxacin is a broad
spectrum Fluroquinolon antibiotics. Is mainly used for various Bacterial Infections. In this tablet bitter taste
was masked by saccharine as sweeting agent furthermore the effervescent effect of citric acid, tartaric acid
and sodium bicarbonate lead to Effervescent activity by realising the CO2 Molecule. Tablets are rapidly
dissolved and rapidly absorbed and give maximum activity. The Prepared Effervescent Tablet is Evaluated
In terms of bulk density, tapped density, angle of repose, Carr’s Index and, hardness test, weight variation
test, friability test and in vitro study. The result associated in Optimized batch is good to Satisfactory and
having a good free flowing property. The hardness, weight variation, and friability these values are within
the pharmacopeia limit. The in vitro Dissolution studies show Maximum percentage of release of drug
(99.26) with in end of 5 min.
Formulation and evaluation ofmetformin HCl micro beads by ionotropic gelation...Sagar Savale
The Metformin HCL Micro Beads is formulated by the Ionotropic Gelation Method. The CMC is a Swellable
polymer is responsible for the Sustained release action or activity. A combination of CMC (Carboxy Methyl
Cellulose) and Sodium Alginate shows better sustained release activity. The PreparedSustained released Micro
Beadsis Evaluated In terms of bulk density, tapped density, angle of repose, Carr’s Index, Swelling Index, Drug
Content, % Encapsulation Efficiency and vitro study. The result associated in Optimized batch is good to
Satisfactory and having a good free flowing property. The Drug Content and % Encapsulation Efficiency values are
within the pharmacopeia limit. The in vitro Dissolution studies shows Maximum percentage of release of drug
(71.15) with in end of 4 Hours.
If revisions are requested, the authors need to address the reviewer's comments and make the necessary changes to the paper. The revised paper is then resubmitted to the journal or conference for another round of review or evaluation of the journalism research paper.
Formulation and evaluation of microspheres with aceclofenacSagar Savale
Aceclofenac is an analgesic and anti-inflammatory drug that reduces fever, pain, and inflammation in rheumatoid
arthritis, osteoarthritis and ankylosing spondylitis. Aceclofenac has higher anti-inflammatory action than
conventional NSAIDs. Development of microspheres is a promising technology for controlled release and drug
targeting. Various types of microspheres such as bio-adhesive, magnetic, floating, radioactive and polymeric
microspheres are developed for various purposes. Microspheres occupied a central place in novel drug delivery, it
can targeted and localized drug delivery system. This Aceclofenac Microsphere is Prepared by using Spray drying
Technique in which release rate of drug is mainly depends on formulation composition (Eudragit RS 30 D and
Ethyl Cellulose (1:2 ratio)). Formulated microspheres were characterized for particle size, encapsulation efficiency
and In vitro studies. The optimum drug-to-polymer ratio and feed flow rate is responsible for higher percent yield,
smaller particle size and maximum encapsulation efficiency.
A comparative study of amlodipine marketed products and their quantitative ev...
Research Paper 3 ijdfr
1. Malani Ketan Ashokbhai et al / IJDFR volume 6 Issue 3 May-June 2015
56 Malani Ketan Ashokbhai / IJDFR volume 6 Issue 3 May-June 2015
Available online at www.ordonearresearchlibrary.org ISSN 2229-5054
INTERNATIONAL JOURNAL OF DRUG FORMULATION AND RESEARCH
FORMULATION, OPTIMIZATION AND EVALUATION OF LIQUISOLID TABLETS
CONTAINING TADALAFIL
Malani Ketan Ashokbhai*, Dr. Tejash Seresiya
Babaria Institue of Pharmacy BITS edu campus Vadodara-Mumbai
Received: 18 Apr 2015 Revised: 14 May. 2015; Accepted: 28 June 2015; Available online: 5 Jul. 2015
INTRODUCTION
The poor dissolution rate of water insoluble drug is still a substantial problem confronting the pharmaceutical
industry. The numbers of new and, beneficial chemical entities do not reach the public merely because of their
poor oral bioavailability due to inadequate dissolution1
.
1.1 Liquisolid System
The technique of ‘liquisolid compacts’ is a new and promising addition towards such a novel aim. The term
‘liquid medication’ implies oily liquid drugs and solutions or suspensions of water insoluble solid drugs carried
in suitable nonvolatile solvent systems termed the liquid vehicles. Due to significantly increased wetting
properties and surface area of drug available for dissolution, liquisolid compacts of water-insoluble substances
may be expected to display enhanced drug release characteristics and, consequently, improved oral
bioavailability1
.
Research- Article
ABSTRACT
Objective:- The aim of our study was to improve the avaibility of Tadalafil a practically insoluble erectile dysfunction
drug. As a model drug by using liquisolid technique. The effect of powder susstrate composition on the flowability and
compressibility of liquisolid compacts were evaluated. Specifically, several liquisolid formulations, containing 10mg
Tadalafil, which containing different carrier to coating ratios in their powder substrates and a fixed liquid medication, were
prepared. The dissolution profiles of Tadalafil liquisolid tablets were determined according to USP method. The obtained
dissolution profile were compared to that of a commercial product. In the present study, the formulated liquisolid systems
exhibited acceptable flowability and compressibility. In addition, liquisolid tablets displayed significant enhancement of
the dissolution profiles compared to this of commercial one.
Results and discussion: Prepared liquisolid tablets were evaluated for pre-compression and post-compression parameters.
Angle of repose, carr’s index and hausner’s ratio were found to be in acceptable range. Hardness, friability, disintegration
time, were found to be in specified range for all formulations. In-vitro drug release of liquisolid tablets were higher
compared to control and marketed tablets due to its less contact angle and more wettability. Significantly improved
dissolution profile was observed for all liquisolid formulation as compared to that of marketed formulation as indicated
from in-vitro dissolution study (108.33%) which was due to presence of polyethylene glycol which increase fluid
penetration in to formulations. Moreover the desirability value of various dependent variables was found to be nearer to
one. Performance of optimized formulation (A1) remained consistence at the end of stability study.
Keywords:- Liquisolid tablets, Tadalafil, PEG 800, Avicel pH 102, Aerosil200, PVP k30
2. Malani Ketan Ashokbhai et al / IJDFR volume 6 Issue 3 May-June 2015
57 Malani Ketan Ashokbhai / IJDFR volume 6 Issue 3 May-June 2015
1.2 Theoretical aspects
The flowability and compressibility of liquid of liquisolid compacts are addressed simultaneously in the ‘new
formulation mathematically model of liquisolid system’,
excipients ratio (R) or the carrier to coating ratio of the powder system use, where,
R = Q/q
R represents the ratio between the weights of carrier (Q) and coating (q) material liquid load factor (Lf) and
defined as the ratio of the weight of liquid medication (W) over the weight of the carrier powder (Q) in the
system.
Lf =W/Q
The powder excipients ratio R and liquid load factors Lf of the formulations are related as follows:
Ф
Lf =Ф + Ф (1/R)
1.3 Classification of liquisolid system
Liquisolid techniques are categorized as per following consideration2
,
A. Based on the type of liquid medication contained in liquisolid systems:
i. Powdered drug solutions
ii. Powdered drug suspensions
iii. Powdered liquid drugs
B. Based on the formulation technique used in liquisolid systems:
i. Liquisolid compacts ii. Liquisolid microsystems
1.4 Advantages of liquisolid systems
Increase bioavailability of poorly water soluble drugs.
Less production cost compared to soft gelatin capsules.
Suitable for industrial production.
1.5 Disadvantages of liquisolid system
Liquisolid system requires low drug loading capacities
Higher amounts of carrier and coating materials are required.
MATERIALS AND METHODS:-
1. Materials
Tadalafil (TDL), were supplied as a gift sample from Alembic Research Ltd (Vadodara, India).Polyethylene
glycol (PEG-800), sodium starch glycolate (SSG), Avicel PH102, Aerosil 200 were procured from Lupin
Research Park (Pune, India). Sodium Laurel Sulphate (SLS) and other raw materials were procured from S. D.
Fine (Mumbai, India).
3. Malani Ketan Ashokbhai et al / IJDFR volume 6 Issue 3 May-June 2015
58 Malani Ketan Ashokbhai / IJDFR volume 6 Issue 3 May-June 2015
2. Equipment
Electric balance (Mettler AJ100, Switzerland), Ultraviolet spectrophotometer (Jenway 6305 uv/vis. UK), Single
Punch tablet press (First Medicine machinery shanghai factory of Dongha Branch, Shanghai, China), Tablet
Hardness tester (Pharmatest, Type PTB 301, Hainburg, Germany), Friability tester (Pharmatest, Type PTF1,
Hainburg, Germany), Disintegration tester (Pharmatest, Type PTZ3, Hainburg, Germany), Dissolution
apparatus.
3. Experimentals:-
3.1 Identification of Drug
3.1.1 By UV spectrophotoscopy
In order to ascertain the optimum wavelengths of Tadalafil, the solution of tadalafil in methanol was scanned on
a UV-Visible spectrophotometer in the range of 200-400 nm against the methanol as blank and sectrum of
tadalafil was recorded as shown in figure 1.1
Figure 1.1: U.V. absorbance of Tadalafil in methanol.
3.1.2 By melting point determination
Open capillary method was used to determine melting point of drug as per pharmacopeia. In this methodology,
a thin glass capillary tube containing a compact colum of the substance to be determined is introduced into a
heated stand (liquid bath or metal block) in close proximity to a high accuracy thermometer. The temperature in
the heating stand is ramped at user-programmable fixed rate until the sample in the tube transitions into the
liquid state. Melting point was found to be 302o
C.
3.1.3 By fourier transform infrared spectroscopy analysis
Identification of Tadalafil was done by FT-IR spectroscopy. The sample was analysed by FTIR instrument
(Bruker, Parul Institute of Pharmacy) and scan was recorded. The obtained IR spectrum is shown in Figure 1.2.
4. Malani Ketan Ashokbhai et al / IJDFR volume 6 Issue 3 May-June 2015
59 Malani Ketan Ashokbhai / IJDFR volume 6 Issue 3 May-June 2015
Figure 1.2: IR spectrum of pure Tadalafil powder
3.2 Preparation of standard calibration curve of Tadalafil
Preparation of stock solution
Two separate stock solution of tadalafil was prepared one by dissolving 50 mg of tadalafil into 50 ml volumetric
flask containing methanol and second by dissolving 10 mg of tadalafil into 100 ml volumetric flask containing
0.5% Sodium lauryl sulphate.
Procedure
Aliquots (0.3 to 2.7 ml) of above prepared stock solution were transferred into series of 10 ml volumetric flask
and diluted with their respective solvents i.e. methanol and 0.5% Sodium lauryl suphate to get concentration of
tadalafil in range of 3 to 19 µg/ml in methanl and 3 to 27 µg/ml in 0.5% Sodium lauryl sulphate respectively.
The resulting solution were analysed at 285 nm for their absorbance against their respective blank in UV
spectrophotometer. The standard calibration curve in both solvent were plotted by taking their respective
absorbance on Y axis and concentration on X axis and it were further used for estimation of tadalafil. The
overlain UV spectra of tadalafil in methanol and 0.5% Sodium lauryl sulphate are shown in Figure 1.3.
(a) (b)
Figure 1.3 Overlain UV spectra of tadalafil in (a) methanol at concentration of 3-19 µg/ml and (b) 0.5%
Sodium lauryl sulphate at concentration 3-27 µg/ml at 285 nm.
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(a) methanol at concentration of 3-19 µg/ml (b) 0.5% Sodium lauryl sulphate at concentration
3-27 µg/ml
3.3 Solubility study
The solubility of Tadalafil in various non-volatile liquid like Propylene glycol (PG), Polyethylene glycol 200
(PEG 200), PEG 400, PEG 600, PEG 800, Cremophor RH 40, Cremophor EL, Tween 20, Span 80, and Tween
40 etc. were performed for the development of liquisolid tablets. Excess amount of Tadalafil is was stirred in 2
ml of each of the selected vehicle and was shaken at 25°C for 48 hr. Supernatants were further diluted with
methanol and analyzed spectrophotometrically at 285 nm for drug solubility3
. From these results, the solubility
of Tadalafil in the respective liquid vehicle was calculated.
3.4 Determination of optimal flowable liquid-retention potential (Ø -value) and liquid load
factor (Lf) determination for carrier and coating materials.
Powder admixture containing 5 gm of either carrier or coating with increasing quantity of non-volatile liquid
vehicle (PEG 800) were mixed using a mortar and pestle. Each admixture was then placed on a shiny metal
plate, the plate was then titled till the admixture slides. The angle formed between the plate and the horizontal
surface, at which admixture slides were measured as angle of slide5
(Φ).
3.4.1 Liquid-retention potential (Ø -value)
In constant weight of carrier/coating material, increasing amount of solvent was incorporated and on each
addition, angle of slide was determined. The flowable liquid
retention potential (Ø -value) of each liquid/powder admixture was calculated using the following equation.
Ø value = weight of liquid/weight of solid ----------- (1)
The Ø -values was plotted against the corresponding angle of slide (for optimal flow properties). Corresponding
to 33o
of a liquid/powder admixture represente the flowable liquid-retention potential.
3.4.2 Determination of liquid load factors (Lf)
Appropriate amounts of carrier and coating materials were used to produce acceptable flowing and compactible
powders which were be calculated using following equation.
y = 0.050x + 0.001
R² = 0.999
0
0.2
0.4
0.6
0.8
1
1.2
0 5 10 15 20
Absorbance
Concentration (µg/ml)
y = 0.034x + 0.010
R² = 0.999
0
0.2
0.4
0.6
0.8
1
1.2
0 10 20 30
Absorbance
Concentration (µg/ml)
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Lf = ØCA + ØCO (1/R) ----------- (2)
Where, Øca and Øco value of carrier and coating material.
The maximum amount of liquid loads on the carrier material, termed ‘‘load factor” (Lf).
3.4 Method of preparation of liquisolid tablets
Several liquisolid tablets were prepared by direct compression method. Tadalafil was dissolved in PEG 800 at
different ratio to obtain various drug concentration. Then a binary mixture of carrier-coating material (avicel pH
102 as the carrier powder and aerosil 200 as the coating material) was added to the obtained liquid medication
under continous mixing in a motor. Depending upon the amount of carrier in formulation, different liquid
loading factor were employed in liquisolid preparations. Finally, 5% (w/w) of sodium starch glycolate as the
disintegrant, 5% (w/w) binder and 1% magnesium stearate were mixed with the mixture for a period of 10 min4
.
The final mixture was compressed using the rotary tablet punching machine to achieve tablet hardness.
3.6 In-vitro release of Tadalafil from liquisolid tablets:-
The in-vitro drug release studies was performed with USP type II paddle apparatus using 1000 ml of 0.5%
sodium lauryl sulfate with paddle rotation mentioned at 37°c ± 0.5°c at 50 rpm. Samples of 5ml were
withdrawn at regular time intervals 5, 10, 15, 30, 45, and 60 minutes obtained samples were filtered using
whatman filter paper and resulting samples was analyzed for absorbance at 284 nm by UV visible
spectrophotometer (UV-1800, Shimadzu, Japan). The spectrophotometric readings were converted into
cumulative percent of drug released using the standard calibration curve of Tadalfil previously constructed.
RESULTS AND DISCUSSION:-
1. Solubility Study:-
The solubility of tadalafil in different non-volatile liquid vehicles namely PEG 200, PEG 400, PEG 600 PEG
800, PG, Cremophor RH 40, Cremophor RH 40, Cremophor EL, Tween 20, Span 80, and Tween 40 were
determined and shown in Tablet 1.1.
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Table 1.1 : Solubility study of tadalafil in various non-volatile solvent (n=3)
Non-volatile liquid Solubility (mg/ml) Non-volatile liquid Solubility (mg/ml)
PEG 800 112.96 + 0.19 Tween 20 14.91 + 0.11
Cremophor RH 40 85.612 + 0.13 Span 80 6.134 + 0.19
PEG 600 72.23 + 0.11 Tween 40 6.57 + 0.29
PEG 400 56.49 + 0.21 Span 20 5.032 + 0.31
Cremophor EL 47.41 + 0.32 PG 1.307 + 0.28
PEG 200 15.98 + 0.26
Result of saturated solubility study of tadalafil in various non-volatile liquid showed the higher solubility of
tadalafil in PEG 800, followed by cremophor RH 40. It was decided to use PEG 800 as non-volatile liquid in the
preparation of liquisolid tablets containing tadalafil.
2. Liquid retention potential of carrier and coating material in PEG 800
Powder admixture containing carrier and coating material with increasing quantity of PEG 800 were mixed
using mortar and pestle and angle of slide was determined. Liquid retention potential of various carrier and
coating material in PEG 800 were shown in Tablet 1.4, and 1.5
Table 1.4: Result of liquid retention potential (Φ-value) of various carrier material (Avicel pH101, Avicel pH
102, Avicel pH 200) in PEG 800 (n=6)
Avicel pH 101 Avicel pH 102 Avicel pH 200
Θ Φ-value Θ Φ-value Θ Φ-value
31.4 + 0.12 0.11 28.73 + 0.16 0.11 33.8 + 0.14 0.11
33.25 + 0.15 0.22 30.84 + 0.12 0.22 32.91 + 0.17 0.22
32.12 + 0.11 0.34 33.09 + 0.11 0.34 31.83 + 0.12 0.34
31.35 + 0.18 0.45 31.98 + 0.17 0.45 30.45 + 0.15 0.45
30.01 + o.13 0.55 31.5 + 0.19 0.55 29.07 + 0.13 0.55
Where, θ= Angle of slide; Φ value= liquid retention potential.
Table 1.5: Result of liquid retention potential (Φ-value) of various coating material (Aerosil, Aerosil 200,
Silicone dioxide) in PEG 800 (n=6)
Aerosil Aerosil 200 Sillicone dioxide
Θ Φ-value Θ Φ-value Θ Φ-value
28 + 0.18 0.225 27 + 0.15 0.225 31.2 + 0.11 0.045
31 + 0.13 0.45 29 + 0.18 0.45 33.05 + 0.16 0.09
33 + 0.19 0.675 31 + 0.11 0.675 32.7 + 0.18 0.135
32 + 0.13 0.9 33 + 0.13 0.9 31.42 + 0.12 0.18
32 + 0.17 1.125 31 + 0.16 1.125 30.21 + 0.14 0.225
32 + 0.12 1.35 30 + 0.12 1.35 29.08 + 0.17 0.27
Where, θ= Angle of slide; Φ value= liquid retention potential.
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From the above results, angle of slide of carrier material avicel pH 102 showed highest liquid retention potential
and coating material Aerosil 200
showed highest liquid retention
potential due to its more surface area
compared to other carrier and coating
materials which is shown Figure 1.4
Figure 1.4: Comparision of Φ value of carrier and coating materials in PEG 800.
3. Determination of liquid load factors (Lf)
From the above result, avicel pH 102 and aerosil 200 were selected as carrier and coating material due to their
high liquid retention potential.
Table 1.6: Result of liquid load factor.
R Lf
10 0.43
20 0.38
30 0.37
Where R= Ratio of carrier to coating ratio; Lf= Liquid load factor.
From above result, it can be concluded that liquid load factor increase with decreasing carrier to coating ratio
(R).
4. Method of preparation of liquisolid tablets:-
Table 1.7: Formulation of Liquisolid tablets according to 32
full factorial design.
Batc
h no
Drug
con in
PEG800
(%w/w)
Drug
(mg)
PEG
800
(mg)
Q:
q
(R)
Lf Q
(mg)
q
(mg)
SSG
(mg)
PVP
(mg)
Mag.
Stear.
(mg)
Total
(mg)
F1 10% 10 100 10 0.43 255.5 25.5 19.5 20.5 4.30 434.8
F2 12% 10 83.3 10 0.43 217.0 21.7 16.6 17.4 3.66 369.6
F3 14% 10 71.4 10 0.43 189.3 18.9 14.4 15.1 3.19 322.4
F4 10% 10 100 15 0.4 275.0 18.3 20.1 21.1 4.64 449.3
F5 12% 10 83.3 15 0.4 233.3 15.7 17.1 17.6 3.76 380.9
F5 14% 10 71.4 15 0.4 203.3 13.5 14.9 15.5 3.28 332.0
F7 10% 10 100 20 0.38 285.0 14.2 20.8 21.5 4.51 456.1
F8 12% 10 83.3 20 0.38 242.4 12.1 17.3 18.2 3.65 387.1
F9 14% 10 71.4 20 0.38 211.4 10.5 15.1 15.9 3.34 337.8
0
10
20
30
40
0 0.5 1 1.5
Angleofrepose
Φ Value
Avicel 102
Aerosil 200
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All formulation contain 5% PVP K30, 5% SSG sodium starch glycolate, 1% mag.stearate; Q= carrier
material(Avicel pH 102); q= coating material(Aerosil 200); Lf= liquid load factor; PEG= poly ethylene glycol.
4.1 Pre-Compression parameters of factorial batches
The prepared liquisolid tablets were prepared by direct compression and were evaluated for pre-compression
parameters as shown in Table 1.8.
Table 1.8: Results of Pre-compression parameters of factorial batches (n=3).
Batch
no
Bulk density
(g/ml) + SD
Tapped density
(g/ml) + SD
Angle of repose
(θ) + SD
Carr’s index
(%) + SD
Hausner’s
ratio + SD
F1 0.27 + 0.20 0.34 + 0.28 31.23 + 0.28 20.88 + 0.18 1.25 + 0.12
F2 0.25 + 0.24 0.30 + 0.13 30.19 + 0.12 17.21 + 0.19 1.20 + 0.22
F3 0.27 + 0.12 0.36 + 0.21 33.11 + 0.26 25.00 + 0.18 1.33 + 0.19
F4 0.26 + 0.28 0.32 + 0.17 28.27 + 0.21 18.75 + 0.14 1.23 + 0.22
F5 0.26 + 0.25 0.30 + 0.12 31.18 + 0.23 13.00 + 0.19 1.15 + 0.23
F6 0.25 + 0.12 0.33 + 0.23 32.2 + 0.13 24.24 + 0.17 1.32 + 0.11
F7 0.27 + 0.29 0.35 + 0.24 29.5 + 0.21 22.85 + 0.13 1.29 + 0.19
F8 0.28 + 0.21 0.32 + 0.27 32.5 + 0.29 12.5 + 0.11 1.14 + 0.22
F9 0.27 + 0.15 0.32 + 0.23 33.2 + 0.17 15.6 + 0.17 1.18 + 0.17
4.2 Evaluation of Post-Compression parameters of factorial batches
All compressed tablets of factorial batches were evaluated for post-comprsession parameters as reported in
Table 1.9.
Table 1.9: Results of post-compresssion parameters of factorial batches (n=3).
Batch Wt. variation
+ SD
Hardness
(kg/cm2
) + SD
Friability
(%) + SD
Diameter
(mm) + SD
Thickness
(mm) + SD
F1 434 + 0.04 3.2 + 0.22 0.30 + 0.21 9.03 + 0.08 6.1 + 0.12
F2 370 + 0.03 3.5 + 0.19 0.54 + 0.17 9.08 + 0.05 5.3 + 0.05
F3 322 + 0.05 3.8 + 0.25 0.56 + 0.25 9.00 + 0.06 4.8 + 0.18
F4 448 + 0.09 4.4 + 0.18 0.26 + 0.20 9.02 + 0.09 6.0 + 0.19
F5 381 + 0.06 4.3 + 0.21 0.33 + 0.23 9.04 + 0.03 5.1 + 0.11
F6 331 + 0.08 4.2 + 0.25 0.24 +0.26 9.07 + 0.18 4.6 + 0.08
F7 456 + 0.04 5.2 + 0.16 0.24 + 0.12 9.00 + 0.04 6.1+ 0.13
F8 387 + 0.05 4.6 + 0.23 0.21 + 0.18 9.06 + 0.13 5.1 + 0.05
F9 337 + 0.07 4.3 + 0.11 0.23 + 0.11 9.01 + 0.11 4.9 + 0.18
Post compression evaluation tests were used to characterize liquisolid tablets. Compressed tablets were of
cylindrical shape and flat faced on both sides. Diameter and thickness of each formulation batch were different
due to difference in composition of each batch.
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Table 1.10: Results of post-compresssion parameters of factorial batches (n=3).
Batch Disintegration Time
(min) + S.D
Drug content
(%) + S.D
F1 1.30 + 0.12 108.18 + 0.28
F2 1.50 + 0.23 95.00 + 0.17
F3 2.0 + 0.19 97.00 + 0.21
F4 4.0 + 0.26 101.0 + 0.15
F5 2.33 + 0.13 98.52 + 0.11
F6 2.30 + 0.24 100.00 + 0.22
F7 7.05 + 0.11 101.00 + 0.18
F8 5.12 + 0.18 98.00 + 0.25
F9 3.08 + 0.12 100.00 + 0.17
5. In-vitro release of Tadalafil from liquisolid tablets:-
In-vitro dissolution study was performed using USP type II apparatus paddle apparatus using 900 ml of 0.5%
SLS with paddle rotation of 50 rpm at 37°c + 0.5°c.
From the different drug release profile of all the formulation, F1 gave fast release as compared to all
formulations. From above table it can be concluded that all liquisolid formulations showed higher drug release
compared to marketed and control formulation.
Figure 1.5: In-vitro drug release profile of Tadalafil from factorial batches.
6. Checkpoint batch compared with marketed product of Tadalafil.
The evaluation study of checkpoint batch (A1) was carried out under same condition as outlined for other
batches and it was compared with marketed product of Tadalafil. % Bias was found to be within acceptable
range. Result of check point batch and marketed product are shown in figure 1.6.
0
20
40
60
80
100
120
0 20 40 60 80
%CummulativeDrug
release
Time (mins)
F1
F2
F3
F4
F5
F6
F7
F8
F9
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Figure 1.6: In-vitro release profile of check point (A1) with marketed tablet (M1).
7. Accelerated stability study
The stability study was performed in accordance to ICH guideline. The samples were analysed for various
evaluating parameters before and after stability study. The results showed good similarity with that of before
evaluated parameters6
.
Table 1.11: Comparison of evaluation parameter of optimized batch A1 before and after stability study.
Parameter Before After
Hardness (kg/cm2
) (Y1) 4.4 4.2
Disintegration (min) (Y2) 4.16 4.10
Q5 (min) (Y3) 20.69 19.13
T50% (Y4) 10.17 10.29
% Dissolution efficiency (Y5) 86.76 86.17
There was no significant change in hardness, disintegration time, Q5, T50% and % dissolution efficiency of
optimized batch A1 after stability study.
8. Differrential scanning calorimetry of drug and formulation
DSC thermograms of pure Tadalafil and other excipients in Figure 1.7, 1.8 indicated qualitative information
about the physical mixture. Pure Tadalafil in Figure 1.7 shows a sharp characteristic endothermic peak at
303.40o
C, is agreeing with its melting temperature (Tm) and denoting that Tadalafil is in crystalline state. The
liquisolid formulation in Figure 1.8 showed absence of endothermic peak. The disappearance of characteristics
peaks of Tadalafil, correspond with formulation of the drug solution in the liquisolid physical mixture due to the
fact that the drug is in a dissolved molecular state. Such disappearance of the drug peak upon the formulation of
the liquisolid system is indicative of complete formulation of an amorphous solid solution.
0
20
40
60
80
100
120
0 20 40 60 80
%Cummulativedrug
Release
Time (min)
A1
M1
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Figure 1.7: DSC thermogram of A1 containing Tadalafil
Figure 1.8: DCS thermogram of A1 containing Tadalafil and excipients.
CONCLUSION:-
In conclusion, liquisolid tablets of Tadalafil could be formulated using PEG 800 as non volatile solvent, avicel
pH 102 as carrier and aerosil 200 as coating material by direct compression method. The proposed design may
be used as an erectile dysfunction ensuring more effective therapy, but additional pharmacokinetic study may be
required to its use in human.
Liquisolid technique was proved to be an effective method for solubility enhancement and improving
dissolution profile of poorly soluble drug Tadalafil. Appropriate selection of liquid vehicle was a critical step to
ensure the overall stability of API and formulation since it affects composition of liquisolid formulation which
ultimately influence pre-compression and post-compression parameters.
Manufacture of liquisolid tablets seems to be exhaustive and multi-step process. Factorial design based
experiments were effectively run and some statistical parameters obtained with software programme which
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were utilized for analyzing crucial effects. Liquisolid tablets of Tadalafil were far better in performance than the
marketed product.
REFERENCES:-
1. Spireas S, International Journal of Pharmaceutics. 1998, 166, 177–188.
2. Spiras S, “Liquisolid system and methods for preparing same.” United states patent 6,423,339 B1. 2002.
3. Saadia AT, “Improvement of dissolution properties of Carbamazepine through application of the
liquisolid tablet technique.” European Journal of Pharmaceutics and Biopharmaceutics. 2008, 69, 342–
347.
4. Elkordy A, “Spironolactone release from liquisolid formulations prepared with Capryol™ 90,
Solutol HS-15 and Kollicoat SR 30 D as non-volatile liquid vehicles.” Eur J. of Pharm. and
Biopharm, 2012, 21-42.
5. Lakshmi VN, “validated spectrophotometric methods for the determination of Tadalafil in
pharmaceutical formulations.” Oriental Journal of Chemistry. 2009, 25(3), 791-794.
6. ICH Harmonised Tripartite Guideline, “Validation of Analytical Procedures: textand Methodology Q2
(R1)”, Current Step 4 version, 2005.