Validation of A Simple HPLC-UV Method For the Quantification of Andrographolide in Self-Nano Emulsifying Drug Delivery System (Snedds) For Dissolution Study

Author(s):  
Syukri Y ◽  
Afetma D. W. ◽  
Sirin M. ◽  
Fajri R. ◽  
Ningrum A. D. K. ◽  
...  

This research aim to validation of a simple, rapid and accurate HPLC-UV method for the quantification of andrographolide isolated from Andrographis paniculata Ness in Self Nano Emulsifying Drug Delivery System (SNEDDS) formulation during the dissolution test. The assay was performed using a XTerra® MS C18 column (150 mm X 4.6 mm, five μm) with a mobile phase of methanol and water (70: 30), at 0.8 mL/min flow rate and UV detection of 229 nm. Simulation gastric fluid (SGF) and intestinal fluid (SIF) were prepared as dissolution medium. The validation parameter was conducted including the test on linearity, precision, accuracy, LOD, and LOQ. The result showed an excellent linearity with r = 0.999 and good selectivity for both medium dissolution. The method showed sufficient precision, with a relative standard deviation (RSD) smaller than % Horwitz. The accuracy reported as % recovery was found to be 102.61 and 101.17 % in each SGF and SIF dissolution medium. LOD and LOQ were found 0.46 and 1.40 in SGF medium, 0.87 and 2.64 in SIF medium. In conclusion, the HPLC method developed showed specificity and selectivity with linearity in the working range, good precision and accuracy and suitable for quantification andrographolide in SNEDDS formulation.

Author(s):  
Christe Mary M ◽  
Sasikumar Swamiappan

Presently, various approaches have been exploited in the prolongation of gastric residence time which includes floating drug delivery system (FDDS), swelling and expanding systems, bio-adhesive systems, modified shape systems and high density systems. Among various methods, floating drug delivery system is considered to be a predominant method. Gastric emptying of dosage forms is an extremely varying process and ability to extend and control the emptying time is a valuable resource for the dosage forms. This FDDS is having the ability to provides a solution for this purpose. The FDDS is a bulk density system lower than the gastric fluid, so that the rest will float on the stomach contents for a prolonged period of time and allowing the drug to release slowly at a desired rate from the system and intensifies the bio-availability of the drug having narrow absorption window. The main intension of writing this review on floating drug delivery system is to study the mechanism of flotation to acheive the gastric retention and to discuss briefly about the background of FDDS, advantages and disadvantages, application of FDDS and factors affecting the gastric retension time.


Author(s):  
Sai Sowjanya Palla ◽  
Rajkumar Kotha ◽  
Anusha Paladugu ◽  
E. Rajesh Kumar Reddy ◽  
Suryasri Lavanya Adavi ◽  
...  

Oral delivery of the drug is by far the most preferable route of drug delivery due to the ease of administration, patient compliance and flexibility in the formulations but has a drawback of non-site specificity and short gastric resident time. In recent years, scientific and technological advancements have been made in the development of novel drug delivery systems by overcoming physiological troubles such as short gastric residence times and unpredictable gastric emptying times. Among Several approaches of floating systems, Bilayer floating technology is considered as promising approach. It combines the principle of bilayer technology and floating mechanism. The combined principle of bilayer floating tablet helps to release initial dose from the immediate release layer to reach the plasma concentration and then the floating layer absorbs gastric fluid forming an impermeable colloidal gel barrier on its surface, maintains a bulk density less than unity and thereby remains buoyant in stomach providing steady state concentration of drug in system. This review focuses on bilayer floating tablet technology a new era of gastro retentive drug delivery system, its advantages over conventional tablets and it also summarizes the bilayer tablet presses used in the industry, formulation design and evaluation parameters of bilayer floating tablets.  


2011 ◽  
Vol 493-494 ◽  
pp. 684-688 ◽  
Author(s):  
Makoto Otsuka ◽  
Hideyuki Hamada ◽  
Kuniko Otsuka ◽  
Hiroyuki Ohshima

A biodegradable drug delivery system was established using an apatite cement containing simvastatin. The in-vitro drug release from apatite with lower-crystallinity was investigated under simulated osteoblast and osteoclast conditions (SOB and SOC). Apatite cement containing 6% simvastatin had lower crystallinity as the same as natural bone. In-vitro drug release tests were performed under SOB in simulated body fluid (pH 7.8), and then under SOC in acetate buffer (pH4.5) at 37.0。C, and the process repeated twice. The device had lower drug release rates under SOB, but significantly higher rates under SOC. The simvastatin release rate was 15 times higher under SOC than SOB. The device showed dissolution medium responsive drug release. After implantation of the APC containing simvastatin in osteoporosis rats, the bone mineral density was evaluated by the X-ray computed tomography. The result indicated that the bone mineral density of APC implanted rat was significantly higher than that of control diseased.


1998 ◽  
Vol 550 ◽  
Author(s):  
E. J. Ginsburg ◽  
T. D. Stultz ◽  
D. A. Stephens ◽  
D. Robinson ◽  
Y. Tian ◽  
...  

AbstractThe dissolution of a drug delivery system consisting of gentamicin sulfate in a hydrophobic polyanhydride matrix has been examined. The in vitro release of gentamicin is a function of the composition of the dissolution medium, with slower release in pH 7.4 buffer than in unbuffered water. This is consistent with an anion exchange taking place under conditions in which carboxylate polymer chain-ends form a poorly soluble salt with gentamicin, and sulfate is released into solution. Results of additional experiments probing this model are digeussed.


2019 ◽  
Vol 9 (4-s) ◽  
pp. 625-630
Author(s):  
Ankita Srivastava ◽  
Ruchi Shukla ◽  
Kusum Sharma ◽  
Hitesh Jain ◽  
D. B. Meshram

Oral route is most preferable and widely used route for the administration of drug. Microballoons becomes novel technology in pharmaceutical field in the floating drug delivery for achieving the gastric retention. Microballoons are also called as hollowspheres which are porous smooth in nature and thus show good floating properties in gastric fluid. Microballoons release the drug in controlled manner at the targeted site. Microballoons are spherical empty vesicles without core and that can remain buoyant in gastric region for prolong period of time without irritation in gastrointestinal tract. Multiparticulate particles having a low density system that can efficiently prolong the gastric retention time of the drugs, thus enhanced bioavailability and thus improve the dosing frequency. These are less soluble at higher pH environment. As microballoons delivery systems provide longer retention in gastric pH and enhance the solubility of drugs that are less soluble in high pH environment. The formation of cavity inside the microballoons depend on the preparation, temperature and the surface smoothness determine the floatability and the release rate of microballoons. Keywords: Microballoons, Gastro retentive drug delivery system, Hollowspheres, Controlled release


Author(s):  
Polkovnikova Yulia Aleksandrovna ◽  
Slivkin Aleksei Ivanovich ◽  
Halahakoon Amila Jeewantha

Objective: The aim of this work was focused on a simple, rapid, accurate and sensitive method for quantitative analysis of afobazole in microcapsules (afb-m) using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection.Methods: The analytical procedure was based on the fractionation characteristics of the afobazole in the chromatography column. The chromatography parameters «Zorbax extend-C18» column (150×2.1 mm i.d. 5 µm particle size), at 40 °C. The isocratic mobile phase was 5.0 M ammonium phosphate buffer (pH 7.0): acetonitrile (30:70; v/v) at a flow rate of at 1.0 ml. min-1. The determinations were performed using UV-Vis detector set at 220 nm.Results: An assay procedure for afb-m has been validated from indices, such as specificity, correctness, precision, and linearity. The registered retention time of the afobazole stock solution and the sample solution was 1.5 min. The determined accuracy of the method was in the range of 99.67%-100.67%. The analytical curve was linear (r2-0.9996) over a wide concentration range (50%-150%). The method showed sufficient precision, with a relative standard deviation (RSD) smaller than 2%.Conclusion: The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of afb-m. The developed assay procedure of afb-m was meeting all the requirements of ICH validation criteria and can be applied for standardisation drug form afb-m.


2016 ◽  
Vol 3 (2) ◽  
pp. 4-12
Author(s):  
RK Yadav ◽  
Satyam Prakash ◽  
K Yadav ◽  
NK Yadav ◽  
M Mostafa

Background  and  Objectives:  The  prevention  and  treatment  of  peptic  ulcers  has  become  an important challenge in the current medicine  world.   Modern progress in novel drug delivery system aims to improve the efficacy of the drug molecule by formulating a dosage form of RHCL. One of the most feasible approaches for achieving a prolonged and predictable drug delivery profile in GI tract is to control the gastric residence time.  Therefore, a multi-unit gastro retentive dosage form of RHCL capable of floating on simulated gastric fluid for more than 12 hours was formulated and evaluated.Materials  and  Methods:  Nine  batches  of  the  light  liquid  paraffin  entrapped  emulsion  gel  beads were  prepared  by  a  new  emulsion  gelation  technique  using  sodium  alginate  and  xanthan  gum  as polymers.  The  polymeric  solution  was  extruded  into  Calcium  chloride  solution  by  the  use  of  21G needles.  Morphology  of  beads,  drug  content,  drug  entrapment  efficiency,  floating  lag  time  and buoyancy were studied. Compatibility study of Ranitidine HCl with polymers used in the formulation was performed using DSC and FT-IR.Results:  Mean  surface  diameter  were  between  1.220  ±  2.259%  (F1)  to  1.230  ±  2.316%  (F9)  and floating lag time were between 6 minute (F9) to 11 minute (F1). All formulations were buoyant for more than 12 hours in simulated gastric  fluid  at  37ºC.  The  drug  content  and  drug  entrapment efficiency  among  the  formulations  were  between  17.48%~19.68%  and  71.06%  ~84.32% respectively. Formulation F1 showed lowest drug content and drug entrapment efficiency while F9 showed highest drug content and drug entrapment efficiency. F4 showed most acceptable sustained drug release profile.Conclusion:  The gastro retentive drug delivery system designed as floating beads was found to be satisfactory drug delivery system for Ranitidine HCl to improve the bioavailability of the drug. Janaki Medical College Journal of Medical Sciences (2015) Vol. 3 (2): 4-12


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