Naseem Charoo

Naseem Charoo
Succor Pharma Solutions · Research and Development

Ph.D.

About

48
Publications
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989
Citations

Publications

Publications (48)
Article
Hyperpigmentation is the most common complaint in the age group 40–45 years, seeking consultation for skin disorders. Hydroquinone is a commonly used depigmenting agent in clinical practice for treating hyperpigmentation. Prolonged use of hydroquinone has been associated with cancer risk and exogenous ochronosis. The CARES (The Coronavirus Aid, Rel...
Article
Full-text available
Many specified impurities in vildagliptin's finished product have been disclosed in the literature that are above their qualification threshold. We used the impurity B (amide impurity) as a case example to explore whether existing literature can be leveraged to determine the safe level of impurity and thereby develop a patient-centric specification...
Article
Sitagliptin is an antihyperglycemic drug used in adults for the treatment of diabetes Type 2. Literature data and in-house experiments were applied in this monograph to assess whether methods based on the Biopharmaceutics Classification System (BCS) could be used to assess the bioequivalence of solid immediate-release (IR) oral dosage forms contain...
Article
Different regulatory agencies provide criteria for selecting a reference product for bioequivalence (BE) studies. In most cases, the criteria vary from one regulatory agency to another, and, consequently, the generic companies often have to repeat the BE studies comparing the same test product with the reference product purchased from a particular...
Article
In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence (BE) testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release (IR) solid oral dosage forms containing moxifloxacin hydrochloride as the sole active pharmaceutical ingred...
Article
Food and Drug Administration (FDA) has approved a drug product (Spritam®) and many medical devices manufactured by 3-dimensional printing (3DP) processes for human use. There is immense potential to print personalized medicines using 3DP. Many 3DP methods have been reported in the literature for pharmaceutical applications. However, selective laser...
Article
The pilot scale batch size for solid oral dosage forms is currently defined by major regulatory agencies as one-tenth of the full production, or 100,000 units, whichever is larger. The current criteria is arbitrary and is not based on scientific and risk assessment principles. The approach does not consider geometric, kinematic and dynamic changes...
Article
The presence of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities in angiotensin II receptor blocker (ARB) drugs containing tetrazole ring has triggered worldwide product recalls. The purpose of this article is to identify the potential gap area in current pharmaceutical industry practice that might have led to the NMDA and...
Chapter
The chapter gives an up-to-date overview on basic concepts relevant to nanoparticles and their impact on bioavailability, as well as the effect of particle size and surface characteristics on biodistribution and cellular uptake of nanoparticles and biomedical application of nanoparticles
Article
Purpose The objective of this article is to review the critical material attributes of pharmaceutical excipients employed in solid dosage manufacturing and link them to critical quality attributes (CQAs). Material attributes can have a profound impact on CQAs of product. Methods The importance of particle size, particle morphology, density, moistu...
Article
Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues....
Chapter
Full-text available
Opioids abuse is an epidemic problem in the US, which can be gauged by consumption level. The US constitutes 5% of world population but consumes 75-80% of global opioids. Prescription opioid abuse has negative consequences on social and economic indicators. FDA has also taken a lead among other federal agencies in combating the prescription abuse b...
Article
Purpose The FDA’s process validation guidance 2011 has rightly resulted in discontinuing the “one size fits all” practice. The guidance aligns process validation with quality by design and quality risk management guidelines. However, the process validation guidance has thrown a challenge with respect to determining the statistically appropriate num...
Article
Objectives Bioequivalence (BE) criteria for amoxicillin–clavulanic acid (Co‐amoxiclav) oral formulations are based on 90% confidence interval for both amoxicillin and clavulanic acid. The aim of this work is to explore the relevance of demonstrating BE of clavulanic acid in Co‐amoxiclav oral formulations and also to assess the impact on safety and...
Article
During solid dosage form manufacturing, the uniformity of dosage units (UDU) is ensured by testing samples at two stages i.e. blend stage and tablet compression or capsule/powder filling stage. The aim of this work is to propose a sample size selection approach based on quality risk management principles for process performance qualification (PPQ)...
Article
Objective: Clinically relevant critical quality attributes (CQA's) were identified for the development of generic drug products containing fluconazole and potential design spaces relevant to the clinical application of the drug candidate was explored. Significance: A simplified scoring system for the biopharmaceutics risk assessment roadmap (Bio...
Article
Background Weight loss medications that were traditionally considered safe and effective are associated with severe adverse effects. Aim The present work seeks to disseminate awareness about the effectiveness and safety of weight loss medications. Methods A descriptive cross‐sectional study was performed across the seven Emirates of the United Ar...
Article
Full-text available
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in thei...
Article
Purpose Research exploring pharmaceutical applications of native sorghum and maize crops is needed to improve their economic competitiveness. Objectives This work assesses the physicochemical and compressional attributes of pregelatinized sorghum and maize starches originating from Sudan and determines whether these attributes are superior than exi...
Article
Due to the higher total clearance of certain drugs in children than in adults, it is recommended that, in such cases, higher relative doses on a milligram/kilogram basis should be administered to children in order to achieve similar systemic exposure to adults. This is the case for fluconazole and ketoconazole. Even though the lower absorptive surf...
Patent
The present invention relates to a pharmaceutical excipient comprising of pregelatinized difra starch and its precursor starch, and their use as novel pharmaceutical excipient thereof. The excellent flow, cohesive and disintegrant properties of pregelatinized difra starch impart the desired characteristics to the oral solid dosage formulations in t...
Article
The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein binding, body water, distribution and metabolism. It is widely recognised that changes in these parameters may result in an alteration of the plasma profile and thus in key bioequivalence parameters such...
Article
Full-text available
The aim of the present work was to establish a bioequivalence-indicating dissolution specification for candesartan cilexetil tablets. The discriminating power of the selected medium (0.25% Polysorbate 20 in pH 6.5 phosphate buffer) was assessed relative to that of 0.35% Polysorbate 20 in pH 6.5 phosphate buffer, a medium recommended by the U.S. FDA...
Article
Literature data pertaining to the decision to allow a waiver of in vivo bioequivalence (BE) testing requirements for the approval of immediate release (IR) solid oral dosage forms containing fluconazole as the only active pharmaceutical ingredient (API) are reviewed. The decision is based on solubility, dissolution, permeability, therapeutic index,...
Article
Estimation of metabolite data as a supportive evidence of comparable therapeutic outcome is recommended by various guidance documents. However, a consensus on using it solely to establish bioequivalence (BE) is lacking as parent drug is believed to detect pharmacokinetic differences between test and reference formulations better. Four BE studies of...
Article
Full-text available
Context: Starch obtained from different botanical sources exhibit different characteristics due to variation in amylase-amylopectin ratio, which results in different binder substrate interactions. Objective: The present study characterized Echinochloa colona (L.) Link (Poaceae) starch and evaluated its compressional characteristics for use as ta...
Article
Full-text available
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification...
Article
Abstract Absence of safe, effective and appropriate treatment is one of the main causes of high mortality and morbidity rates among the pediatric group. This review provides an overview of pharmacokinetic differences between pediatric and adult population and their implications in pharmaceutical development. Different pediatric dosage forms, their...
Article
Abstract The aim of this work was to find the effect of temperature and manufacturing source of phenylmercuric nitrate (PMN) on PMN absorption on low-density polyethylene (LDPE) and polypropylene containers in chloramphenicol eye drops. Two factorial experiments were designed to study the effect of temperature on PMN assay in chloramphenicol eye dr...
Article
Abstract The focus of the present study was to develop and evaluate the transdermal system of celecoxib. Transdermal gels composed of carbopol 940 in propylene glycol (PG) containing penetration enhancers. The formulations were characterized by permeation, pharmacokinetics, pharmacodynamics and histopathology. Celecoxib permeation across excised ra...
Article
The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by...
Article
The focus of the current investigations was to apply quality by design (QbD) approach to the development of dispersible tablets. Critical material and process parameters are linked to the critical quality attributes of the product. Variability is reduced by product and process understanding which translates into quality improvement, risk reduction...
Article
Full-text available
The efficacy of oral aspirin treatment in the secondary prevention of cardio and cerebro vascular disease is well known. However oral administration is often associated with abdominal discomfort. The feasibility of delivering aspirin transdermally from eudragit and polyvinyl acetate (PVA) matrix-type patches to enhance its antithrombotic efficiency...
Article
The stratum corneum (SC) is a primary rate limiting barrier to permeation of drug molecules through the skin. Small molecular weight lipophilic drugs that are effective at low doses can be effectively delivered by passive transdermal delivery. The SC does not permit passage of polar/hydrophilic and macromolecules. Passive and physical penetration e...
Article
This article describes the development and validation of a first derivative UV quantitative analytical method for determination of candesartan cilexetil in tablet dosage forms. A signal at 270.1 nm of the first derivative spectrum (ID270.1) was found adequate for quantification. The limit of quantification was 3.06 µg/ml. The linearity between ID27...
Article
Penetration enhancing potential of tulsi and turpentine oil on transdermal delivery of flurbiprofen, a potent non-steroidal anti-inflammatory agent, was investigated. The transdermal permeation rate of flurbiprofen across the rat abdominal skin from binary solvent mixture composition of propylene glycol (PG):isopropyl alcohol (IPA) (30:70%, v/v) wa...
Article
The aims of this investigation were to determine the distribution in the gastrointestinal (GI) tract of Eudragit S-100 encapsulated colon-specific sodium alginate microspheres containing 5-fluorouracil (5-FU) in rats, and to perform pharmacokinetic and pharmacodynamic studies. Comparisons were with a control immediate-release (IR) formulation of 5-...
Patent
The present invention relates to a pharmaceutical composition of alendronic acid and pharmaceutically acceptable salts thereof.
Article
Full-text available
The purpose of this investigation was to prepare and evaluate the colon-specific microspheres of 5-fluorouracil for the treatment of colon cancer. Core microspheres of alginate were prepared by the modified emulsification method in liquid paraffin and by cross-linking with calcium chloride. The core microspheres were coated with Eudragit S-100 by t...
Article
A simple reversed-phase HPLC method has been developed for determination of flurbiprofen in rat plasma, excised skin extract, and transdermal patch formulations. The mobile phase was methanol–1% (v/v) phosphoric acid in water, 80:20 (v/v), at a flow rate of 0.5 mL min-1; ibuprofen was used as internal standard. Flurbiprofen and ibuprofen was detect...
Article
The enhancing effects of lemon oil on the transdermal penetration of flurbiprofen through rat skin invitro and in vivo was investigated. The maximum flux achieved by Isopropyl alcohol (IPA):Propylene glycol (PG) (70:30% v/v) solvent mixture was further increased by lemon oil. The flux of flurbiprofen through ethylene vinyl acetate microporous membr...
Article
Reservoir-type ocular inserts were fabricated using sodium alginate containing ciprofloxacin hydrochloride as the core (drug reservoir) that was sandwiched between the Eudragit and/or polyvinylacetate films. Ocular inserts were packaged in aluminium foil and sterilized by gamma radiation. These were tested for sterility as per British Pharmacopoeia...
Article
Sol-to-gel systems of ciprofloxacin hydrochloride were prepared utilizing the phase transition properties of hydroxy propyl methyl cellulose K 15 M grade (HPMC) and carbopol 934. The sol-to-gel systems were sterilized by gamma radiation and/or filtration. The sol-to-gel systems were evaluated for rheological characteristics, in vitro release behavi...

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