Current Issue : April - June Volume : 2012 Issue Number : 2 Articles : 8 Articles
The aim of present study is to prepare and evaluate HPMC AS enteric coated microspheres to avail the drug at intestine and its distal part using Budesonide as model drug. The microspheres were prepared by emulsion solvent-evaporation method using HPMC AS MF. A 32 full factorial design was applied to optimize the formulation variables. From the preliminary study, it was concluded that independent variables Span 80 concentration (X1) and Polymer: Drug ratio (X2) showed significant effect on the dependable responses. All prepared microsphere were free flowing and spherical in shape. Optimized batch exhibit microspheres size 74.49 �µm, encapsulation efficiency 62.09 %w/w, Drug Release2hr 5.32 % and Drug Release5hr 81.3 %. Results of 32 full factorial design confirmed that independent variables has significant effect over the dependent responses which can be seen from the surface response graphs. The linear correlation plots drawn between the predicted and the observed responses demonstrated higher values of R2 (ranging between 0.991 and 0.999), indicating excellent fitting of the model. Upon comparison of the observed responses with that of the predicted responses, the standard error varied between 0.2250 and 2.35. Thus, the low magnitudes of standard error as well as the significant values of R2 in the current study indicate a high prognostic ability of BDS-HPMC AS MF microsphere optimization using 32 full factorial design....
Fast dissolving drug delivery is rapidly gaining acceptance as an important new drug delivery technology. The dosage form to disintegrate rapidly in the patient's mouth within a minute and can be gulped easily, thus, it offers increased patient compliance and convenience. The purpose of this work is to formulate and evaluate orally disintegrating tablet (ODT) of Lamotrigine with quick disintegration/dispersion in mouth (<30 sec), sufficient mechanical strength to withstand handling during manufacture, packing and distribution with pleasant mouth feel and palatable taste. ODT of lamotrigine is prepared by direct compression method using different proportion of diluents, superdisintegrants, sweeteners, flavors and lubricant. These preparations are evaluated for physical appearance, dimension, crushing strength, weight variation, friability, oral dispersion time, de-aggregation study, wetting time, In vitro dissolution study, drug content, stability study and effect of excipients. This study showed good drug release profile and other parameters were also in acceptable range. Optimized batches DC13 revealed satisfactory results, required for ideal ODT. . This batch was suitable for scale-up and bioequivivalance (BE) study. Summarizing all parameters, it can be concluded that ODT are the better option for improving patient convenience and compliance....
Oxcarbazepine is having poor water solubility and suffering with dissolution rate limited bioavailability. It belongs to class II category under biopharmaceutical classification and needs to improvement of dissolution. Various approaches for improving dissolution rate were reported previously but there is no reports regarding the impact of pharmaceutical factors on the dissolution rate of Oxacarbazepine. The present study is representing the data regarding the effect of various excipients (diluents, superdisintegrants, and lubricants) and method of preparation on the dissolution rate of Oxacarbazepine. oxcarbazepine tablets composed with the diluent (mannitol), super disintegrant (crospovidone), lubricant (magnesium stearate) and the glidant (talc) and compressed by employing direct compression technique was found to comply all the official quality control tests and produced more drug release among the other formulations and offered the similarity in dissolution profiles, as the value of similarity factor value is more than 50....
There is an abundance of information about drugs available on the Web. Data sources range from medicinal\r\nchemistry results, over the impact of drugs on gene expression, to the outcomes of drugs in clinical trials. These\r\ndata are typically not connected together, which reduces the ease with which insights can be gained. Linking\r\nOpen Drug Data (LODD) is a task force within the World Wide Web Consortium�s (W3C) Health Care and Life\r\nSciences Interest Group (HCLS IG). LODD has surveyed publicly available data about drugs, created Linked Data\r\nrepresentations of the data sets, and identified interesting scientific and business questions that can be answered\r\nonce the data sets are connected. The task force provides recommendations for the best practices of exposing\r\ndata in a Linked Data representation. In this paper, we present past and ongoing work of LODD and discuss the\r\ngrowing importance of Linked Data as a foundation for pharmaceutical R&D data sharing....
Particle Replication in Non-Wetting Templates (PRINT) is a platform particle drug delivery technology that coopts the precision\r\nand nanoscale spatial resolution inherently afforded by lithographic techniques derived from the microelectronics industry to\r\nproduce precisely engineered particles. We describe the utility of PRINT technology as a strategy for formulation and delivery\r\nof small molecule and biologic therapeutics, highlighting previous studies where particle size, shape, and chemistry have been\r\nused to enhance systemic particle distribution properties. In addition, we introduce the application of PRINT technology towards\r\nrespiratory drug delivery, a particular interest due to the pharmaceutical need for increased control over dry powder characteristics\r\nto improve drug delivery and therapeutic indices. To this end, we have produced dry powder particles with micro- and nanoscale\r\ngeometric features and composed of small molecule and protein therapeutics. Aerosols generated from these particles show\r\nattractive properties for efficient pulmonary delivery and differential respiratory deposition characteristics based on particle\r\ngeometry. This work highlights the advantages of adopting proven microfabrication techniques in achieving unprecedented control\r\nover particle geometric design for drug delivery....
In present work, concurrent process validation of Pantoprazole Sodium 40 mg delayed release tablets was carried out to monitor process parameters in current production batches. The process validation was divided into two major steps, first one is process validation of dosage form before coating and second one is after coating. In-process quality monitoring of all critical processing steps was done for three production batches, before coating and after coating. End product testing of current production batches was done to provide documented evidence that manufacturing process is in state of control. Assay for drug content was within the limit of 100%-104% at the dry mixing stage. LOD for the dried granules after wet granulation was within 1-4% RSD. Assay after lubrication was within the specified limit at different corners in the blender, indicating blend uniformity. Physical parameters like average weight of core tablet was found to be 180.95%-182.25%, thickness was found to be between 3.25 cm-3.60 cm, hardness was found to be 5.08kg/cm2-5.65kg/cm2, %friability was between 0.117%-0.134%. disintegration time was 181sec -202 sec, assay of core tablets 99.54%-100.13 % for all the three batches of compressed tablets. Two coatings were applied on the core tablets, base coating and enteric coating. Base coating using OPADRY polymer and enteric coating using ACRYL EZE polymer. Temperature monitoring was done throughout the coating process. After coating percentage weight build up was within 10%-12%. Finished product assay was between 99.56%-100.23%. No dissolution of active occurred in acidic medium up to 2 hours, drug release in buffered medium was within the limit of 96%-100% within 30 min. Average weight of coated tablet was between 200.52mg-202.37mg. Diameter of coated tablets was 9.1mm- 9.19mm. Thickness was 3.97cm-3.99 cm. Uniformity of dosage forms for 10 dosage unit is between 98.91%- 99.05%, which is within the acceptance limit of = 15 %. Blister strip packing was carried out for the tablets. During packing operation each pack size was checked for physical appearance and sealing quality and found satisfactory. All the tests were found to have satisfactory results. Thus process validation of pantoprazole tablets was successfully completed and found within the specifications....
The present study involves the scale up studies of lansoprazole delayed release capsules and establishment of uniformity of various scale up parameters, critical process variable assessment. Delayed release capsules of lansoprazole were formulated using drug layering and enteric coating technology for oral administration. Lansoprazole and other excipients are layered around d the sugar spheres with the help of binding agent HPC and sucrose. The drug layered pellets were then coated with enteric coating agent (Eutragit – 3- D-55 in FBP (wurster coating) and subjected to lubrication using talc followed by drying for 4hrs. all the process parameters were validated and the results suggests that the lansoprazole delayed release capsules can be produced in large scale by the validated parameters. The validated parameters can be recommented for execute batch production of lansoprazole delayed release capsules....
The manufacturer of pharmaceutical product is intended to assist to the extent possible in the establishment of a single set of global specifications for new drug substances and new drug products. It provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic ,chemical origin, and new drug products produced from them, that have not been registered previously. The design and conduct of pharmaceutical development studies should be consistent with their intended scientific purpose. It should be recognized that the level of knowledge gained, provide the basis for science based submission and their regulatory evaluations. The stability studies are designed to evaluate the impact of temperature excursions on product quality that may occur during distribution. Specification address only the marketing approval of new drug product and where applicable, new drug substance, they are applied to products containing synthetic APIs (including antibiotics), semi synthetic antibiotics and synthetic peptides of low molecular weight, but not to higher molecular weight peptides, and complex biotechnological or biological APIs.\r\nThe study present a brief definition of each concept and an indication of circumstances under which it may be applicable.Generally proposals to implement these concept should be justified by the applicant and approved by the appropriate regulatory authority before being put into effect....
Loading....