
Pramod KumarJSS College of Pharmacy | JSSCP · Department of Pharmaceutics
Pramod Kumar
M.Pharm, PhD
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Introduction
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Publications
Publications (154)
Antimicrobial resistance (AMR) is a global public health crisis that impedes the therapeutic effectiveness of available antimicrobial agents. Due to the high burden of infectious diseases and limited resources, especially trained healthcare professionals, low- and middle-income countries (LMICs) are particularly susceptible to the detrimental effec...
Iron deficiency is the principal cause of nutritional anemia and it constitutes a major health problem, especially during pregnancy. Despite the availability of various non-invasive traditional oral dosage forms such as tablets, capsules, and liquid preparations of iron, they are hard to consume for special populations such as pregnant women, pedia...
The “Internet of things (IoT)” is a modern-day phenomenon that defines physical objects or groups of such objects, with sensors, processing ability, software, and other technologies that connect and exchange data with other devices and systems over the Internet or other communications networks. The field has evolved due to the convergence of multip...
Orodispersible films (ODFs)are ultra-thin, stamp-sized, rapidly disintegrating, and attractive oral drug delivery dosage forms best suited for the pediatric and geriatric patient populations.They can be fabricated by different techniques, but the most popular, simple, and industrially applicable technique is the solvent casting method (SCM). In add...
Orodispersible films (ODFs) are ultra-thin, stamp-sized, elegant, portable and patient-centric pharmaceutical dosage forms that do not need water to be ingested. They are particularly useful for paediatric and geriatric patient populations with special needs such as dysphagia, Parkinson's disease, and oral cancer. Accordingly, they hold tremendous...
Artificial intelligence is an emerging sector in almost all fields. It is not confined only to a particular category and can be used in various fields like research, technology, and health. AI mainly concentrates on how computers analyze data and mimic the human thought process. As drug development involves high R & D costs and uncertainty in time...
Orodispersible film (ODF) formulations are promising and progressive drug delivery systems that are widely accepted by subjects across all the age groups. They are traditionally fabricated using the most popular yet conventional method called solvent casting method. The most modern and evolving method is based on printing technologies and such prin...
COVID-19 has spread out its wings across the globe and is taking away many lives. Millions of people are (self) quarantined to prevent the spread of this viral disease. World Health Organization (WHO) has affirmed that there is not any medicine for COVID-19. Besides, there is also no single drug that is approved by any regulatory agency for usage a...
The promising potential of nano-structured lipid carrier (NLC) polymeric gel of CUR as an effective treatment for rheumatoid arthritis by intra-articular route of administration was investigated. NLC composed of cetylpalmitate, Labrafac PG & Captex 200, Tween 80 and Labrasol. The hot homogenization method employed by melt ultrasonication was used....
Rheumatoid arthritis (RA) is considered a debilitating disease that increases the risk of significant morbidity and premature mortality. To circumvent drug-related toxicity and ineffectiveness of anti-inflammatory drugs, there is a significant need for an advanced delivery system that increases bioavailability. The feasibility of in situ gel of met...
The traditional oral dosage forms (tablets, capsules, syrups, and elixirs) suffer from various disadvantages. They are pretty challenging to administer to patients with dysphagia, mucositis, and vomiting tendency. Therefore, gaining patient compliance using conventional dosage forms is highly cumbersome. One of the most transformative and innovativ...
Medical device vigilance is concerned about device problems (incidents) their analysis and mitigation to ensure that device performance is good and that patient safety are maintained. The main aim of this is to outline the criteria of the medical device vigilance program and to highlight the requirements that still remain in the state laws of regul...
Orodispersible Film (ODF) is a promising and progressive dosage form that offers exceptional drug delivery benefits to patients. Indeed, they are the most transformational alternatives to traditional or conventional tablets or capsule dosage forms. ODFs are portable and highly comfortable for self-administration by patients with swallowing problems...
Orodispersible Thin Films (OTF) are the most innovative and patient centered novel drug delivery systems. Many Pharmaceutical companies and academic experts across the world are already in the process of exploring the true potential of these films in delivering drugs not only from synthetic source but also from natural source. The beauty of this un...
Regenerative medicine is a new and expanding field in biomedical research. Organ and tissue loss through disease and injury, propel the development of a treatment that can regenerate tissue and help for less relaying in organ transplantation. Regenerative medicine has the potential to heal tissue and damaged organ. Currently, a patient suffering fr...
The In-Vitro Medical Devices Directive (IVDD) established in 1998 by the European Union met the requirements of the single medical device market. In the due course, IVDD could not regulate all new technical and medical developments in the sector. The IVDD 98/79/EC, was preceded with IVDR 2017//746; which defined and demonstrated conformity to essen...
The U.S. Congress passed Medical Device User Fee Act (MDUFA), where FDA is required to assign and collect fees from manufacturers of medical devices to evaluate the functioning and the usage of the device. for the purpose of fastening the analysis of the application of the drug. The Medical Device User Fee Modernization Act was first adopted in 200...
Aim
It aims the latest legislative foundation for the placing In vitro diagnostic equipment on the European market, making them accessible and putting them into service in vitro diagnostic medical device on European market.
Background
As a consequence of sustained scientific and technological advancements, the directive 98/79/EC is no longer ‘fit...
The pharmaceutical industry is the one which was developed every year with aim of public health, safety and its financial growth. Keeping the public safety in mind the industry people are mostly concentrated on novel plans in the drug development process and restarting again how to increase in releaving of disorder and also increase accuracy in pat...
Osteoporosis is a condition in which the body loses bone density and turns weak. Solid Lipid Nanoparticles (SLN) are potential, biocompatible and efficient nanocomposite system, which when combined with thermosensitive injectable sol-gel systems turn into an effective and efficient drug delivery system. The present study, aims to design and develop...
Rheumatoid arthritis (RA) is a debilitating condition that results in impairment of joints and ligaments and thus constrained mobility and decreased array of movement. It is a broad expression that encompasses additional 100 very diverse disorders mainly affecting joints. In the field of drug discovery, there is no well-known treatment for RA that...
Personalized medicine (PM) has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The way we understand and treat disease is changing rapidly. The traditional form of personalized medicine has been based on the observable manifestations of a disease or treatment, such as a tumour on...
The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and e...
The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatening damages to the patients in world in some emergency conditions. The aim of this work is to give an overview on EUA in life threat...
The use of software in a medical device allows the manufacturer to concentrate on the application needed to run device-specific functions. The medical device manufacturer using software generally neglect software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device. Software c...
Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinati...
India is one of the developing countries. A substantial proportion of population of this country is largely exposed to the drug market whose purchasing power is extremely low. Around 42% population of this country lives under the National poverty line ($1.25 per day). Vital issue concerning them is to access the health care facility at an affordabl...
Healthcare providers are now using a relatively new method called e-prescribing (electronic prescribing) which uses a computerized system to reduce medication prescribing errors and to improve communication between physicians, pharmacists, and patients. Generate a prescription that is then transmitted through a special network to the pharmacy in su...
The process of attaining and maintaining data integrity is critical to ensure a successful clinical trial. Data integrity is a fundamental component of information security. in its broadest use, data integrity refers to the accuracy and consistency of data stored in the data base, warehouse, data mart or other construct. The development of time sav...
Digital health is an ongoing revolution that combines technology with personal health and genetic information to better improve the efficiency and delivery of healthcare, and make medicine more personalized and precise. It helps to track, manage and improve our own and our family’s healthcare and health. A massive part of the driving force behind d...
Blood transfusion plays an important role in the improvement of health and saves many lives. Haemovigilance system is the programme which ensures the transfusion safety by monitoring every step of transfusion process from donor to recipient. The ultimate object of haemovigilance system is improving the quality and safety of transfusion therapy. Thi...
Pharmacy is the health profession that links the health science with chemical science and it is charged with ensuring the safe and effective use of pharmaceutical drugs. Gujarat has been one of the pioneer States in India with an exemplary track record. The State of Gujarat have country's most dynamic entrepreneurs who are original and fast-paced i...
Blood transfusion plays a key role in improving health and saves many lives. Haemovigilance system is the programme which ensures the transfusion safety by monitoring every step of transfusion process from donor to recipient. This system mainly focused on collection and analysis of data concerned with adverse events/reactions related with transfusi...
The world today isn’t the one which it was yesterday. With the continuing evolution in technology and technological applications on medical field, innovative products and services have been emerging every day. Wearable gadgets have risen up as revolution in the medical field for patient care. A number of tech giants are pouring into this segment; w...
The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smart phone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of...
Polymeric-blend beads of ghatti gum with sodium alginate containing the drug, galantamine hydrobromide were prepared by varying the gum concentrations and cross linkers viz., CaCl2 and AlCl3. It was found that in comparison between AlCl3 and CaCl2, the particle size, percent yield and drug entrapment efficiency was greater in beads prepared by AlCl...
Healthcare technology is a growing concern in the world today. The amalgamation of advancements in technology with healthcare surely demands inevitable play of regulation on the same. This article throws light on regulation of healthcare technology which is a systematic application of knowledge in the form of devices, drugs, procedures and systems...
In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanism...
To achieve efficient development of medical devices, globalization is a key to success. Spending large amounts of money in different regions for medical device development is no longer feasible. Harmonization-by-doing (HBD) is an initiative taken by USFDA and MHLW-Japan for speedy approval of Medical Devices. The main goal of this program is to red...
Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices throughclinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, test potentialtreatments in human volunteers to see whether they should be approved for wider use in the general population. Atreatmen...
Timely identification and reporting of medical device problems are critical for post-market surveillance programs to enhance public health by gathering information about the incidence of adverse experiences. The establishment of Unique Device Identification (UDI) system is of critical importance to fulfil the promise of a robust and multifaceted po...
Timely identification and reporting of medical device problems are critical for post-market device, surveillance programs to enhance public health by gathering information about the incidence of adverse experiences with devices. The establishment of the Unique Device Identification (UDI) system is of critical importance to fulfil the promise of a r...
The objectives of this review were to provide an overview of existing regulations on nutrition labelling and health claims. Consumers gather information about the foods they purchase from a wide variety of sources. Family knowledge, education, the media and advertising, all convey messages about different food characteristics; information may also...
ABSTRACT Rheumatoid arthritis (RA) is a painful, debilitating disease characterized by inflammation of the joints, with the proliferation of the synovium and the progressive erosion of cartilage and bone. The treatment of RA is still unsatisfactory, but a number of powerful disease-modifying antirheumatic drugs have become available, such as methot...
This review focuses on principles of product preservation, preservatives, and novel technologies for the future development of preservative free herbal products. The purpose of this study was to determine the amount of preservatives in pharmaceutical products as some recent studies reported serious side effects associated with the ingestion of thes...
The present study envisages the preparation of transdermal matrix patches of Glibenclamide containing different ratios of Polyvinyl pyrrolidone K-30 and Eudragit RS100 polymeric combinations with propylene glycol (PG) served as plasticizer as well as a penetration enhancer by solvent
evaporation technique. The drug excipient compatibility was studi...
Methotrexate (MTX) is the drug of choice for the treatment of rheumatoid arthritis (RA). At present there exists a lacuna in delivering methotrexate in suitable dosage form to maintain optimum plasma concentration to achieve therapeutic efficacy during the treatment period. Exposure of MTX at higher concentrations resulted in severe side effects. M...
Regulatory Dossier contains data which when submitted to the regulatory authority, provides for the review andultimate approval of a drug product. Once approved, an applicant may manufacture and market the drug to provide asafe, effective and low cost which benefits the society. Filing requirements in developed countries differ fromdeveloping count...
The term “medical device” covers a vast range of equipment, from simple tongue depressors to hemodialysis machines. Like medicines and other health technologies, they are essential for patient care. With the increased use of medical devices, stringent regulatory standards are required to ensure that the devices are well studied, safe, and well tole...
The objective of the study was to design and evaluate a novel superporous hydrogels (SPHs) for application as gastroretentive dosage form of losartan potassium. The semi-interpenetrating polymer network (IPN) SPHs of polyvinyl pyrrolidone and chitosan was synthesized by crosslinking chitosan with glyoxal. SEM photographs show the presence of interc...
Periodontitis is an inflammatory condition affecting teeth resulting in progressive destruction of periodontal ligaments, resorption of alveolar bone and loss of teeth. Treatment of periodontitis includes surgical and non surgical management. Systemic antibiotics are also used for the treatment of periodontitis. The aim of this research was to form...
The present investigation was designed with the intention to formulate a versatile 5-fluorouracil(5-FU) matrix tablet surpassing issues associated with current conventional chemotherapeutic drug delivery systems. The novel 5-FU matrix tablet fulfills therapeutic needs by engineering matrix tablets utilizing chitosan-sodium alginate interpolyelectro...
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Pre-market...
The objective of this article is to facilitate regulatory requirements for the approval process of Biosimilars and the need for Biosimilar product class-specific guidelines in Regulated (EU, US, JAPAN) and emerging markets (KOREA, CHINA, INDIA). Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. Specifi...
The aim of the present work was to prepare floating tablets of diltiazem HCl using kondagogu gum as matrix forming carrier. Diltiazem HCl, having an elimination half-life of about 3.5 hrs, is a calcium channel blocker used in treatment of several diseases of the cardiovascular system, especially angina and hypertension. The matrix tablet formulatio...
Several ophthalmic delivery systems have been developed to prolong the pre-corneal-drug contact time for enhancing diffusion and to improve ocular bioavailability. In situ gelling systems prolong the corneal contact time, thereby improving bioavailability and are convenient to administer. The aim of the present study was to develop a novel thermose...
The pharmaceutical market worldwide, after experiencing a slump during the past 2-3 years, is now in its recovery period. Decline in global pharma market was largely due to the economic slowdown, and further aggravated by patent expiry of key blockbusters together with saturation in key pharma markets, such as the US and Western Europe. Meanwhile,...
The aim of the work is to modify the solubility and bioavailability of Losartan potassium, by employing non-effervescent floating drug delivery (tablet dosage forms). Non-effervescent systems are a type of floating drug delivery systems that have been used to boost the gastric residence and the floatation time in the gastro intestinal tract. The st...
Effective air flow distribution through perforated tiles is required to efficiently cool servers in a raised floor data center. We present detailed computational fluid dynamics (CFD) modeling of air flow through a perforated tile and its entrance to the adjacent server rack. The realistic geometrical details of the perforated tile, as well as of th...
Precipitation method is employed for preparation of chitosan and polycarbophil interpolyelectrolyte complex (IPEC) followed by characterization with Fourier transform infrared spectroscopy (FT-IR), Differential Scanning calorimeter (DSC) and X-ray Diffraction (XRD). 5-FU tablets were prepared by direct compression using IPEC. Six formulations were...
The aim of the present work was to prepare floating tablets of diltiazem hydrochloride using ghatti gum as a matrix polymer. The tablet formulations were prepared by varying the concentrations of ghatti gum, sodium bicarbonate and hydroxy propyl methyl cellulose (HPMCK4M). The tablets were prepared by direct compression technique using PVP K-30 as...
This chapter introduces a number of emerging topics in data center design and operation. The use of ambient air, water, or ground for heat rejection is attractive for many facilities whenever the environmental conditions are conducive. Changes in equipment layout and real-time control of cooling and information technology (IT) resources also offer...
Robust regulatory arrangements provide the foundation for a national method of medicine safety, and for public confidence in medicines. This article focuses on the need to sharpen the regulatory requirements for pharmacovigilance in India. To be effective the remit of drug regulatory authorities needs to go further than the approval of new medicine...
Tizanidine hydrochloride (THCl) is an antispasmodic agent which undergoes extensive first pass metabolism making it a possible candidate for buccal delivery. The aim of this study was to prepare a monolayered buccal patch containing THCl using the emulsification solvent evaporation method. Fourteen formulations were prepared using the polymers Eudr...
A variety of approaches have been studied in the past to overcome the problems encountered with the delivery of antifungal, for effective treating of oral and vaginal candidiasis. In this study, a novel mucoadhesive tablets with pH-independent drug release characteristic was prepared by chitosan and carbopol® 71G interpolymer complex (IPC) claims f...
The objective of present study was to document the requirements for inspection of tablet manufacturing facilities as per USFDA (United States Food and Drug Administration) guidelines. US FDA guide provides information regarding the inspection and evaluation of the solid oral dosage form manufacturing facilities with greater emphasis on validation a...
Biomarkers and surrogate endpoint largely replaced the clinical trials which are needed to be carried out before drug approval in regular approval process under FDA (Food and Drug Administration), a governing pharma regulatory body in USA and as a result approval process can be accelerated. It can be said that surrogate endpoint and biomarker are s...