Formulation and invitro evaluation of delayed release multiple unit pellets of Lansoprazole in capsules

2021 ◽  
pp. 2625-2630
Author(s):  
Suresh Kolli ◽  
K. Vijayasri ◽  
P.N. Murthy
Keyword(s):  
Acidic Environment ◽  
Drug Content ◽  
Delayed Release ◽  
Accelerated Stability ◽  
Ich Guidelines ◽  
Compressibility Index ◽  
Release Studies ◽  
Enteric Polymer ◽  
Multiple Unit ◽  
Tapped Density

The present research was aimed to formulate and evaluate Lansoprazole delayed release multiple unit pellets in capsules. Lansoprazole degrades in the acidic environment of the stomach. It is also unstable under conditions of high temperature and high humidity which leads to therapeutic inefficiency. Hence it is important to bypass the acidic pH of the stomach. Protection of drug from acidic environment is done by coating the drug with enteric polymer. In the present study, successive layers of drug layer, barrier layer and enteric layer was coated on the inert sugar spheres by using solution/suspension layering technique in Fluidized bed processor (FBP). The prepared drug layered and barrier layered pellets were evaluated for % yield. The prepared lubricated pellets were evaluated for flow properties i.e., bulk density, tapped density, compressibility index and hausner’s ratio. Lubricated pellets filled into size ‘1’ capsules and evaluated for drug content, drug content resisted in acid, invitro drug release studies and compared with the marketed product. The dissimilarity and similarity factors for the optimized and marketed formulations were found to be 84.29. Accelerated Stability Testing (AST) was performed as per the ICH guidelines at 40±5°C/75±5% RH for 6 months and found satisfactory.

scholarly journals THE INFLUENCE OF HPC-L AND EUDRAGIT L30 D-55 ON DELAYED RELEASE OMEPRAZOLE MAGNESIUM MULTIPLE-UNIT PELLET SYSTEM

2018 ◽  
Vol 11 (7) ◽  
pp. 178
Author(s):  
Varalakshmi Mummidi ◽  
Shaik Rezwana
Keyword(s):  
Drug Loading ◽  
Film Coating ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Gastric Parietal Cell ◽  
Delayed Release ◽  
Barrier Coating ◽  
Accelerated Stability ◽  
Multiple Unit ◽  
Stomach Ph

Objective: The objective of the study is to develop optimum, stable, delayed release pellets of omeprazole magnesium (20.6 mg dose). Omeprazole magnesium is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ -ATPase at the secretory surface of the gastric parietal cell, which is orally administered drug, whereas omeprazole magnesium is degraded in stomach pH, so it is formulated as delayed release dosage form to absorb in intestinal pH.Methods: The formulation of delayed release pellets of omeprazole magnesium was developed by enteric film coating process varying the compositions of drug loading, barrier coating, and enteric coating using fluid bed processor. The prepared multiple pellets were filled into hard gelatin capsules as a single unit dosage forms.Results: The dissolution profile of formulation (F8) contains the efficient amount of hydroxypropyl cellulose-L and Eudragit L30 D55 leads to effective release of drug in 30 min. Fourier transform infrared and differential scanning colorimeter studies were conducted for the optimized formula to prove that the formula was not having incompatibility between the drug and excipients. The scanning electron microscopy studies were conducted to know the surface morphology of the pellets.Conclusion: It was concluded that optimized formulation (F8) shown good similarity with innovator. The results of the accelerated stability of final formulation revealed that storage conditions were excellent.

scholarly journals MULTIPLE UNIT PELLET SYSTEM (MUPS) BASED FAST DISINTEGRATING DELAYED-RELEASE TABLETS FOR PANTOPRAZOLE DELIVERY

2018 ◽  
Vol 10 (1) ◽  
pp. 77
Author(s):  
Sandipkumar A. Patel ◽  
Nrupa G. Patel ◽  
Abhijeet B. Joshi
Keyword(s):  
Drug Release ◽  
Physical Properties ◽  
Microcrystalline Cellulose ◽  
Release Profile ◽  
Drug Release Profile ◽  
Delayed Release ◽  
Fluid Bed ◽  
Enteric Polymer ◽  
Multiple Unit ◽  
Extrusion Spheronization

Objective: The rationale for the study was to develop multiple unit pellet system (MUPS) of delayed release pantoprazole with desired physical properties and unaltered drug release profile from pellets even after compression into a fast disintegrating tablet.Methods: In the presented study, delayed release pellets of pantoprazole were developed by two methods, i.e. extrusion-spheronization and drug layering techniques, coated using enteric polymer and subsequently compressed in to tablet. In drug layering technique, pantoprazole was loaded on Celphere®102 (microcrystalline cellulose spheres) as well as on Suglet® (sugar spheres) in fluid bed processor. Acid resistant polymer Eudragit ND 30D was subsequently coated on each type of drug loaded pellets. Suitable tableting excipients were prepared such as soft pellets, Ceolus® (fibrous grade of microcrystalline cellulose) granules, Ludipress® (compressible lactose composition), Avicel® PH 200 and different combination of them. Various factors like property of pellets to be compressed, coating level, the composition of tableting excipient and ratio of drug-loaded pellets to tableting excipients were identified and optimized.Results: MUPS with delayed releasing pellets of pantoprazole proved to provide sufficient hardness, rapid disintegration property, and unaltered release profile after compression. Delayed release pantoprazole pellets prepared by drug layering on celphere® 102 followed by coating with Eudragit® NE 30D showed better compressibility to withstand the drug release properties. The combination of Ceolus® granules and Ludipress (in 1:1 ratio) was found to be suitable tableting excipient that helped compression of pellets without rupturing polymeric coat. Pellets to excipients ratio at 1:3 was found optimum.Conclusion: Compaction behaviour of pantoprazole delayed-release pellets without loss of original delayed release profile was achieved by formulating as MUPS based tablet of pantoprazole delayed release pellets using celephere® 102 was developed which was found suitable for desired release profile and physical properties.

scholarly journals Formulation and Evaluation of Amoxicillin Trihydrate Lozenges

2015 ◽  
Vol 14 (1) ◽  
pp. 61-70 ◽  
Author(s):  
S Vidyadhara ◽  
RLC Sasidhar ◽  
B Deepti ◽  
E Wilwin ◽  
B Sowjanyalakshmi
Keyword(s):  
Research Work ◽  
Dosage Forms ◽  
Content Uniformity ◽  
Artificial Sweetener ◽  
Weight Variation ◽  
Accelerated Stability ◽  
Ich Guidelines ◽  
Saccharin Sodium ◽  
Amoxicillin Trihydrate ◽  
Dsc Analyses

In the present investigation an attempt has been made to formulate medicated lozenges containing amoxicillin trihydrate. There are several amoxicillin trihydrate dosage forms in the market such as tablet, capsule, suspension and syrup. Still there is a need for more variant dosage forms which acts effectively and locally. The benefits of the present research work is to increase the retention of the dosage form in oral cavity for increased bioavailability, reduction in gastric irritation and bypassing first pass metabolism. The lozenges were prepared by heating and congealing method employing polyethylene glycol 1500 as matrix base, saccharin sodium (artificial sweetener), stevia (natural sweetener), xanthan gum (polymer), sodium carboxymethyl cellulose (polymer) as other exciepients. The prepared medicated lozenges were characterized for drug content uniformity, hardness, thickness, weight variation, friability and dissolution by standard pharmacopeal methods. The results of the evaluation tests obtained were within the limits. Accelerated stability studies were conducted as per ICH guidelines and found that there wasn’t any substantial interaction among the drug, flavour and colour and the prepared formulations were found to be stable. Formulations were tested for drug exciepients interactions subjecting to IR spectral and DSC analyses. The results revealed that there was no major interactions between the drug and polymers used for the preparation of lozenges.Dhaka Univ. J. Pharm. Sci. 14(1): 61-70, 2015 (June)

scholarly journals Design and evaluation of Pulsatile drug delivery of Losartan Potassium

2014 ◽  
Vol 12 (2) ◽  
pp. 119-123
Author(s):  
MS Ashwini ◽  
Mohammed Gulzar Ahmed
Keyword(s):  
In Vitro Release ◽  
Losartan Potassium ◽  
Stability Studies ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Weight Variation ◽  
Release Studies ◽  
The Stability ◽  
Vitro Release

The study was designed for the investigation of pulsatile device to achieve time or site specific release of Losartan potassium based on chronopharmaceutical considerations. The basic design involves the preparation of cross linked hard gelatin capsules by using formaldehyde, then the drug diluent mixture were prepared and loaded in, which was separated by using hydrogel plugs of different polymers of different viscosities. Prepared formulations were subjected to evaluation of various parameters like weight variation, percentage drug content, in vitro drug release and stability studies. Weight variation and percentage drug content results showed that they were within the limits of official standards. The in-vitro release studies revealed that the capsules plugged with polymer HPMC showed better pulsatile or sustained release property as compared to the other formulations. The stability studies were carried out for all the formulations and formulations F1 & F2 were found to be stable. Dhaka Univ. J. Pharm. Sci. 12(2): 119-123, 2013 (December) DOI: http://dx.doi.org/10.3329/dujps.v12i2.17610

scholarly journals Development of Rapid UV Spectrophotometric Method for the Estimation of Efavirenz in Formulations

2010 ◽  
Vol 7 (3) ◽  
pp. 856-860 ◽  
Author(s):  
Y. Anand Kumar ◽  
N. Rama Rao
Keyword(s):  
Statistical Methods ◽  
Spectrophotometric Method ◽  
Solvent System ◽  
Sodium Lauryl Sulphate ◽  
Total Drug ◽  
Drug Content ◽  
Oral Formulations ◽  
Ich Guidelines ◽  
Sample Recovery ◽  
Good Agreement

Simple, sensitive, accurate, precise and rapid ultraviolet (UV) spectrophotometric method was developed for the estimation of efavirenz in pure form, its formulations and stability samples. For the estimation of efavirenz, solvent system employed was 1% w/v sodium lauryl sulphate (SLS) and wavelength of detection (λdet) was 247 nm. The developed method was used to estimate the total drug content in two commercially available oral formulations of efavirenz and recovery studies were also carried out. Sample recovery in both the formulations using the above method was in good agreement with their respective labeled claims, thus suggesting the validity of the method and non-interference of formulation excipients in the estimation. The developed method was found to be stability specific and were validated as per ICH guidelines-2005, USP-2000 and statistical methods.

scholarly journals Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
C. O. Migoha ◽  
M. Ratansi ◽  
E. Kaale ◽  
G. Kagashe
Keyword(s):  
Visible Region ◽  
Active Pharmaceutical Ingredient ◽  
Test Time ◽  
Sieve Analysis ◽  
Formulation Development ◽  
Compressibility Index ◽  
Enteric Coated ◽  
Time Changes ◽  
Preformulation Studies ◽  
Tapped Density

Preformulation is an important step in the rational formulation of an active pharmaceutical ingredient (API). Micromeritics properties: bulk density (BD) and tapped density (TD), compressibility index (Carr’s index), Hauser’s ratio (H), and sieve analysis were performed in order to determine the best excipients to be used in the formulation development of omeprazole magnesium enteric coated tablets. Results show that omeprazole magnesium has fair flow and compressibility properties (BD 0.4 g/mL, TD 0.485 g/mL, Carr’s index 17.5%, Hauser’s ratio 1.2, and sieve analysis time 5 minutes). There were no significant drug excipient interactions except change in colour in all three conditions in the mixture of omeprazole and aerosil 200. Moisture content loss on drying in all three conditions was not constant and the changes were attributed to surrounding environment during the test time. Changes in the absorption spectra were noted in the mixture of omeprazole and water aerosil only in the visible region of 350–2500 nm. Omeprazole magnesium alone and with all excipients showed no significant changes in omeprazole concentration for a 30-day period. Omeprazole magnesium formulation complies with USP standards with regards to the fineness, flowability, and compressibility of which other excipients can be used in the formulation.

scholarly journals FORMULATION AND EVALUATION OF PRESS COATED TABLETS OF LANSOPRAZOLE

2019 ◽  
pp. 49-56
Author(s):  
Prasanthi D ◽  
PRASHANTI. S ◽  
MEGHANA G
Keyword(s):  
Ethyl Cellulose ◽  
Chemical Properties ◽  
Enteric Coating ◽  
Scanning Calorimetry ◽  
Dsc Studies ◽  
Delayed Release ◽  
Ich Guidelines ◽  
Physico Chemical ◽  
Enteric Coated ◽  
Core Tablet

Objective: Lansoprazole an proton pump inhibitor, degrades in acidic environment, hence protection of drug is done by coating the drug with enteric coating polymers. The aim and objective of the present study was to prepare enteric coated delayed release tablets of lansoprazole by using press coating technique. Methods: Core tablets were prepared by direct compression and evaluated for their physico-chemical properties. Press coated tablets were formulated by using different combinations of ethyl cellulose, HPMC E15 and HPMC K4M as a coating layer. Core and coated tablets were optimized by dissolution studies. Fourier transform infra-red spectroscopy (FTIR) and differential scanning calorimetry (DSC) studies were performed to know the compatibility of drug with various excipients. Surface morphology and uniformity of coat was evaluated by Scanning electron microscopy (SEM). Stability of optimized formulation was evaluated according to ICH guidelines. Results: Among the various formulations F5 containing ethyl cellulose: HPMC E15 (10:90) and F9 containing ethyl cellulose: HPMC K4M (25:75) were optimized based on the better drug release within 8 h. DSC studies and FTIR studies revealed compatibility of drug with excipients. Obtained SEM photographs of tablets showed that the surface of core tablet is uniformly coated with coat by press coating. Stability studies showed that the formulations were stable. Conclusion: As a result, delayed release press coated tablets developed in this study delivered lansoprazole in the intestine and protected the drug from degradation.

scholarly journals Design, Fabrication and Evaluation of Drug Release Kinetics from Aceclofenac Matrix Tablets using Hydroxypropyl Methyl Cellulose

1970 ◽  
Vol 8 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Abul Kalam Lutful Kabir ◽  
Bishyajit Kumar Biswas ◽  
Abu Shara Shasur Rouf
Keyword(s):  
Drug Release ◽  
Sustained Release ◽  
Release Kinetics ◽  
Matrix Tablets ◽  
Angle Of Repose ◽  
Release Mechanism ◽  
Matrix Tablet ◽  
Drug Content ◽  
Compressibility Index

The objective of this study was to develop a sustained release matrix tablet of aceclofenac usinghydroxypropyl methylcellulose (HPMC K15M and HPMC K100M CR) in various proportions as release controllingfactor by direct compression method. The powders for tableting were evaluated for angle of repose, loose bulkdensity, tapped bulk density, compressibility index, total porosity and drug content etc. The tablets were subjected tothickness, weight variation test, drug content, hardness, friability and in vitro release studies. The in vitro dissolutionstudy was carried out for 24 hours using United States Pharmacopoeia (USP) 22 paddle-type dissolution apparatus inphosphate buffer (pH 7.4). The granules showed satisfactory flow properties, compressibility index and drug contentetc. All the tablets complied with pharmacopoeial specifications. The results of dissolution studies indicated that theformulations F-2 and F-3 could extend the drug release up to 24 hours. By comparing the dissolution profiles with themarketed product, it revealed that the formulations exhibited similar drug release profile. From this study, a decreasein release kinetics of the drug was observed when the polymer concentration was increased. Kinetic modeling of invitro dissolution profiles revealed the drug release mechanism ranges from diffusion controlled or Fickian transport toanomalous type or non-Fickian transport, which was only dependent on the type and amount of polymer used. Thedrug release followed both diffusion and erosion mechanism in all cases. The drug release from these formulationswas satisfactory after 3 months storage in 40°C and 75% RH. Besides, this study explored the optimum concentrationand effect of polymer(s) on acelofenac release pattern from the tablet matrix for 24 hour period.Key words: Aceclofenac; sustained release; hydrophillic matrix; HPMC; direct compression.DOI: 10.3329/dujps.v8i1.5332Dhaka Univ. J. Pharm. Sci. 8(1): 23-30, 2009 (June)

Stability Study of fast Disintegrating tablets of Nisoldipine as per ICH Guidelines

2021 ◽  
pp. 5843-5844
Author(s):  
Seema Saini ◽  
Rajeev Garg
Keyword(s):  
Research Work ◽  
Storage Period ◽  
Pharmaceutical Product ◽  
Stability Study ◽  
Disintegration Time ◽  
Drug Content ◽  
Ich Guidelines ◽  
Significant Difference ◽  
Fast Disintegrating Tablet ◽  
The Stability

The stability study is a critical parameter to be evaluated in a pharmaceutical product development cycle. A pharmaceutical scientist pays a great deal of heed in testing a product stability. The present research work focused on conducting stability study of fast disintegrating tablet batch of Nisoldipine (NFDT). The various parameters evaluated were weight, hardness, friability, disintegration time, drug content and % drug released. The stability study of optimized fast disintegrating tablet batch NFDT was performed according to ICH guidelines. For the study plan, fast disintegrating tablet batch was placed in a wide mouth air tight containers, which were charged into the stability chamber. The temperature was adjusted at 40°C ± 2°C and relative humidity of 75% ± 5%. The study period was of 6 months. The fast disintegrating tablet batch NFDT did not showed any significant difference in weight, hardness, % friability and disintegration time. The drug content was also reported to be in limits of acceptance. The % drug released at various time intervals was insignificantly changed during its storage period. Hence, the prepared tablets were stable during their storage period.

scholarly journals FORMULATION AND EVALUATION OF FAMOTIDINE FAST DISSOLVING TABLETS USING SYNTHETIC SUPERDISINTEGRANTS

2019 ◽  
pp. 17-25
Author(s):  
SARIPILLI RAJESWARI ◽  
M. YERNI KUMARI
Keyword(s):  
Drug Release ◽  
Microcrystalline Cellulose ◽  
Research Work ◽  
Content Uniformity ◽  
Short Term ◽  
In Vitro Drug Release ◽  
Term Stability ◽  
Drug Content ◽  
Release Studies

Objective: The main aim of the present research work was to formulate fast dissolving tablets of famotidine by direct compression method and to evaluate the effect of synthetic super disintegrating agent on drug release pattern. Methods: The fast dissolving tablets were prepared by using crospovidone, croscarmellose sodium, sodium starch glycolate as superdisintegrants (2, 4 and 6 %w/w), mannitol 20 % and microcrystalline cellulose (44, 46 and 48 % w/w) as a directly compressible vehicle. All the prepared tablets were evaluated for hardness, friability, drug content uniformity, weight variation, disintegrating time, wetting time and in vitro drug release studies. Results: All the prepared fast dissolving tablets formulations were within the Pharmacopoeial standards limits. Based on in vitro drug release studies (>90 % within 30 min), the optimised formulations were optimised tested for the short term stability (at 40 ˚C/75% RH for 3 mo) and drug excipient interaction (fourier transform infrared spectroscopy). Conclusion: Hence, formulation prepared with 6 % w/w of crosspovidine and 44 % w/w of microcrystalline cellulose as emerged as the overall best formulation (>90 % within 30 min) compared to marketed product (>70 % within 30 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro drug release (p<0.05).

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