Research & Reviews: A Journal of Drug Formulation, Development and Production
type: channel
description: Research & Reviews: A Journal of Drug Formulation, Development and Production (RRJoDFDP) is a Journal focused towards the publication of current Research/Review work carried out in area of Drug Formulation and development. The Journal covers all major areas involved in Drug Formulation and production. The focus and the scope of journal includes: original research findings that fall under the broad field of Drug Formulation and development ; including, but not limited to the following subject areas: e-ISSN: 2394-1944 Focus and Scope Covers Drug Development Novel drug delivery systems International Drug regulatory Affair Pharmacodynamics & pharmacokinetics Medicinal Chemistry Topical Formulations Galenic formulations Injectable formulations Sub-micron and Nano-emulsions All contributions to the journal are rigorously refereed and are selected on the basis of quality and originality of the work. The journal publishes the most significant new research papers or any other original contribution in the form of reviews and reports on new concepts in all areas pertaining to its scope and research being done in the world, thus ensuring its scientific priority and significance.
language: en
publication name: Research & Reviews: A Journal of Drug Formulation, Development and Production
issn: 2394-1944
copyright: Copyright Transfer and Declaration Form (Please compile this form, sign and send by e-mail and post) Journal Title: Title of the Paper: Corresponding Author’s Information: Name: Address: E-mail: Contact Number: I t is herein agreed that: The copyright to the above-listed unpublished and original article is transferred to STM Journals. This copyright transfer covers the exclusive right to reproduce and distribute the contribution, including reprints, translations, photographic reproductions, microform, electronic form (offline, online), or any other reproductions of similar nature. I/We declare that above manuscript is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere. I/ We warrant(s) that his/her/their contribution is original, except for such excerpts from copyrighted works as may be included with the permission of the copyright holder and author thereof, that it contains no libelous statements, and does not infringe on any copyright, trademark, patent, statutory right, or propriety right of others. I/We will not publish his/her/their above said contribution anywhere else without the prior written permission of the publisher unless it has been changed substantially.I/We also agree to the authorship of the article in the following order:Author(s) Name Signature(s) 1. ________________ 2. _______________ _3. ________________ 4. ________________ The author(s) agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal (comments if any to the editor can be added below).
items: Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario
items: Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.
items: Formulation and Evaluation of Domperidone Medicated Jelly Using Solvent Deposition Method for Solubility Enhancement
items: Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management
items: Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development
items: Formulation Development and Evaluation of Opthalmic Ocusert Containing Timolol Maleate
items: Formulation and Development of Gastroretentive Hydrogels of Glipizide
items: Metabolomics: At a Glance
items: Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements
items: Regulatory Requisites for Registration Process of Medical Devices in United States
items: Spectrofluorimetric Method for the Estimation of Avanafil in Bulk and their Tablet Dosage Form
items: In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development
items: Hepatic Disorders: Ayurvedic Perspective
items: A Brief Note On Different Concept Of Biowaiver
items: Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing
items: Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC
items: An Overview of GMP Requirements for Drug Product in China
items: Formulation and Evaluation of Meloxicam Crystals Using Spherical Crystallization for Solubility Enhancement
items: AN OVERVIEW OF GMP REQUIREMENTS FOR GENERICS IN BRAZIL AND RUSSIA
items: Pastillation—Towards Next Generation Particle Engineering
items: Synthesis, Characterization and Pharmacological Evaluation of Amide Derivates of Prednisolone
items: Formulation and Evaluation of Microencapsulated Levofloxacin Gel
items: Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Macrolide Immunosuppressant Substance and Drug Product
items: Formulation Development of Otic In Situ Gel containing Lomefloxacin Hydrochloride
items: Supergenerics Regulation in India and US: A Comparative Review

Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario
type: item
description: Abstract The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available guidelines and map the general requirements for registration. Keywords: Biosimilar, import, export, registration Cite this Article Jinish Dhar M, S.B. Puranik. Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 32–39p.
subject: Review Articles
  topic: section
creator: Jinish Dhar M
creator: S. B. Puranik
rights: Copyright (c)
date: 2017-10-05
publication date: 2017-10-05
starting page: 32
ending page: 39

Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.
type: item
description: Abstract The Rx-to-OTC switch was a phenomenal success in USA, which was based on risk/benefit ratio of all scientific evidences in collaboration with FDA, manufacturer and consumers. Different surveys speak about the success stories of Rx-to-OTC movement as consumers experience the benefit from self-care in terms of empowerment, convenience, savings of money and time, etc. OTC perspective of scientific and regulatory bodies is based upon a valid procedure and just not goes on the benefits of manufacturers. Before switching any of the drug or molecule or ingredient, specific target population is looked out and followed by easily recognizable conditions, symptoms and evaluating the actual need of identified switch. There are various regulatory angles to OTC legislations, and this article have focused on few key of them such as safety, efficacy, clinical trial requirements, manner of labeling to be, and available regulatory pathways. Keywords: Switch, over-the-counter, safety, efficacy, labeling, regulations
subject: Review Articles
  topic: section
creator: Gaurav Agnihotri
creator: Deepak Pandurang Belsare
rights: Copyright (c)
date: 2017-10-05
publication date: 2017-10-05
starting page: 24
ending page: 31

Formulation and Evaluation of Domperidone Medicated Jelly Using Solvent Deposition Method for Solubility Enhancement
type: item
description: Abstract Objective: The purpose of this study is to develop and characterize medicated jelly of Domperidone. Domperidone is associated with poor aqueous solubility and dissolution rate and thus exhibit a poor bioavailability. Solvent deposition is a promising method to improve the solubility of poor water soluble drugs. Methods: Solvent depositions were prepared for optimization and evaluated for percentage drug content, invitro dissolution, solubility analysis. Optimization of Domperidone solvent deposition was done using 32 Factorial design.Optimized formulation was incorporated into jellies and were examined. Results: In-vitro dissolution studies showed that solvent deposition enhances the dissolution properties of pure Domperidone. The in vitro drug release study of medicated jelly indicates that it enhances the dissolution property of Domperidone. Stability studies of prepared medicated jellies confirm that it remain stable throughout the period of study. Conclusion: The solvent deposition prepared in this work is known to improve solubility and dissolution characteristics of a poor water soluble drug Domperidone. The prepared medicated jellies can be a promising dosage form for delivery of drugs. Keywords: Solvent deposition, domperidone maleate, jelly, optimization, solubility enhancement Cite this Article Arun Raj. R, JibcyFeba Rachel John, Jyoti Harindran. Formulation and Evaluation of Domperidone Medicated Jelly Using Solvent Deposition Method for Solubility Enhancement. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 40–53p.
subject: Research Articles
  topic: section
subject: Solvent deposition
  topic: keywords
subject: Domperidone Maleate
  topic: keywords
subject: Jelly
  topic: keywords
subject: Optimization
  topic: keywords
subject: Solubility enhancement
  topic: keywords
creator: Arun Raj. R
creator: Jibcy Feba Rachel John
creator: Jyoti Harindran
rights: Copyright (c)
date: 2017-10-05
publication date: 2017-10-05
starting page: 40
ending page: 53

Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management
type: item
description: Abstract Short term self-medication has tremendous power in lowering the burden of medical practitioners. Responsible self-care allows everyone to maintain their healthcare status with limited involvement in obtaining guidance from other health care practitioners such as pharmacists, etc. Although most of the EU countries have adopted to formal procedure of switch to change the class from Rx to OTC category, still there are chances to harmonize the mechanism of switch process by means of rationalizing factors getting impacted due to diverse regulatory environment in each of those countries/markets. Assessing complexities in existing situation will help identify solutions for future to mitigate and lower the risks associated with regulatory diversifications. Giant markets like US, Australia, New Zealand, China, etc., have implemented categorization of drugs as prescription drugs and non-prescription drugs, the one which is recognized as, ‘Over The Counter’. And because of which these markets could provide patients speedy recovery by means of elevating standards of self-care management. Keywords: Self-medication, over the counter (OTC), switch mechanism, regulatory environment Cite this Article Gaurav Agnihotri, Sonal Shidhore, Abhijit Chile et al. Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 17–23p.
subject: Review Articles
  topic: section
creator: Gaurav Agnihotri
creator: Sonal Shidhore
creator: Abhijit Chile
creator: Vijay Patil
creator: Deepak Pandurang Belsare
rights: Copyright (c)
date: 2017-10-05
publication date: 2017-10-05
starting page: 17
ending page: 23

Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development
type: item
description: Abstract Bioavailability (BA) has an important role in new drug discovery and product development in pharmaceutical field. The solubility and permeability are important parameters of biopharmaceutics and have central role in lead optimization by controlling the pharmacokinetic parameters to give better therapeutic activity. Biopharmaceutical classification system (BCS) is a drug development tool that is based on correlation of solubility and permeability with bioavailability of drug in human body. The principles of BCS are widely applicable in development of new drug and new drug product as the scientific approach for testing of waiver on clinical study and bioavailability of drug and in regulatory approvals of drug. This review article gives an overview of BCS with special emphasis on concept, classification, class boundaries determination, extension and BDDCS with brief idea on applications. Finally, future prospects and limitations are pointed out. Keywords: Biopharmaceutical classification system, solubility, bioavailability, intestinal permeability, bioequivalence, product development, BDDCS Cite this Article Chavda Vivek P, Sanjay Desai, Moinuddin Soniwala. Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 1–16p.
subject: Review Articles
  topic: section
creator: Vivek P. Chavda
creator: Sanjay Desai
creator: Moinuddin Soniwala
rights: Copyright (c)
date: 2017-10-05
publication date: 2017-10-05
starting page: 1
ending page: 16

Formulation Development and Evaluation of Opthalmic Ocusert Containing Timolol Maleate
type: item
description: Abstract The aim of formulating timololmaleate occusert was to prolong the drug residence time after ocular administration to achieve the controlled release of drug. Timolol maleate is an antiviral agent and it is used in the treatment of viral infections like herpes simplex infections. Ocular inserts were prepared by solvent casting method. Drug reservoir and rate controlling membrane were prepared using different hydrophilic and hydrophobic polymers respectively with polyethylene glycol 400 as the plasticizer. The ocuserts were evaluated for their physical and chemical and in vitro release characteristics. The developed formulation was stable sterile and non-irritant. The final formulation F2 was subjected to UV irritation for sterilization. In the present work it was concluded that the F2 formulation shows 99.80% controlled release upto 8 h when compared to other formulations. Keywords: Timolol maleate, ocusert, hydroxy propyl cellulose Cite this Article Shanmugam S, VetrichelvanT. Formulation Development and Evaluation of Opthalmic Ocusert Containing Timolol Maleate.Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 8–12p.
subject: Research Articles
  topic: section
creator: S. Shanmugam
creator: T. Vetrichelvan
rights: Copyright (c)
date: 2017-05-03
publication date: 2017-05-03
starting page: 8
ending page: 12

Formulation and Development of Gastroretentive Hydrogels of Glipizide
type: item
description: Abstract The aim of the present study was to develop a pH sensitive gastroretentive drug delivery system for an antidiabetic drug glipizide, based on gas formation technique using 32-factorial design, in order to prolong the gastric residence time and increase the overall bioavailability of the dosage form, since the absorption is erratic in diabetic patients. The system consists of the drug, glycol chitosan (5% w/w) and aqueous PVA solution (10% w/w) which were mixed together and pH was adjusted to 4.5–5.0. Then the crosslinking agent (10% aqueous glyoxal) was added, followed by sodium bicarbonate which acts as foaming agent. In acidic environment, superporous hydrogels showed higher swelling ratio because of the cationization of amine groups. The presence of PVA and increased levels of crosslinker significantly improved the mechanical strength of the superporous hydrogels. The drug release studies showed that sustained release of drug could be achieved with high crosslink density and higher amount of PVA. Keywords: Hydrogels, pH sensitive, gastroretentive, glipizide, factorial design Cite this Article Vasanth Samaga, Puranik SB. Formulation and Development of Gastroretentive Hydrogels of Glipizide. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 1–7p.
subject: Research Articles
  topic: section
creator: Vasanth Samaga
creator: S. B. Puranik
rights: Copyright (c)
date: 2017-03-09
publication date: 2017-03-09
starting page: 1
ending page: 7

Metabolomics: At a Glance
type: item
description: Abstract Metabolomics is the branch of science which provides the comprehensive analysis of metabolites in a biological system which in turn is useful as a marker. Metabolomics analysis is useful for ascertaining human health conditions.It will provide an insight to cellular metabolism. Since the metabolome directly reflects physiological states, it can biochemically monitor disease states and assess drug actions, improving the preclinical to clinical translation and focusing on predictability, efficiency and improving productivity. The metabolite profile will be useful for early impact of drug in the body.Tissue extraction, sample preparation, data acquisition, and data mining are one of the keen points to be considered. This article is grafted with an aim to provide an overview of metabolomics to the reader. Keywords: Omic science, metabolomics, drug discovery Cite this Article Chintan Patel, Jignesh Bhadani, Vivekchavdaet al.Metabolomics: At a Glance.Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 23–30p.
subject: Review Articles
  topic: section
creator: Chintan Patel
creator: Jignesh Bhadani
creator: Vivek Chavda
creator: Moinuddin Soniwala
creator: Sanjay Desai
rights: Copyright (c)
date: 2017-05-29
publication date: 2017-05-29
starting page: 23
ending page: 30

Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements
type: item
description: Abstract The main aim of this article was to study the various pharmaceutical products registration processes, regulations and requirements by the Indian Regulatory Authorities.The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and dietary supplements and to evaluate the available guidelines and map the general requirements for registration. Keywords:regulatory approvals, import, export, registration Cite this Article Dhar MJD, Puranik SB, Mithun EG. Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements.Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 13–22p.
subject: Review Articles
  topic: section
creator: Jinish Dhar M
creator: S. B. Puranik
creator: Mithun E. G.
rights: Copyright (c)
date: 2017-05-29
publication date: 2017-05-29
starting page: 13
ending page: 22

Regulatory Requisites for Registration Process of Medical Devices in United States
type: item
description: Abstract A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which isrecognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes". Keywords:Medical device, registration, US FDA Cite this Article Sharath S, Puranik SB, Mohammed Mubeen Ahmed. Regulatory Requisites for Registration Process of Medical Devices in United States.Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 31–41p.
subject: Review Articles
  topic: section
creator: Sharath S.
creator: S. B. Puranik
creator: Mohammed Mubeen Ahmed
rights: Copyright (c)
date: 2017-05-29
publication date: 2017-05-29
starting page: 31
ending page: 41

Spectrofluorimetric Method for the Estimation of Avanafil in Bulk and their Tablet Dosage Form
type: item
description: Abstract A simple and sensitive spectrofluorimetric method has been developed for estimation of Avanafil in bulk and in their tablet dosage form. Avanafil in methanol produces fluorescence at 367 nm (λem) with excitation at 314 nm (λex). Linearity range was found to be 200–1000 ng/ml with correlation co-efficient 0.999. The limit of detection (LOD) and limit of quantitation (LOQ) for the developed method were found to be 7.32 and 22.18 ng/ml, respectively. The developed method was found to be specific, sensitive, accurate and precise. It was successfully used for estimation of Avanafil in its tablet dosage form. The content of Avanafil in two marketed formulations was found to be 96.91 and 97.95% of label claim. Keywords: Avanafil, spectrofluorimetric method, excitation, emission Cite this Article Pratik M. Tailor, Vrutika V. Patel, Ashish D. Mishra et al. Spectrofluorimetric Method for the Estimation of Avanafil in Bulk and their Tablet Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 17–21p.
subject: Research Articles
  topic: section
creator: Pratik M. Tailor
creator: Vrutika V. Patel
creator: Ashish D. Mishra
creator: Shailesh A. Shah
creator: Dinesh R. Shah
rights: Copyright (c)
date: 2017-01-17
publication date: 2017-01-17
starting page: 17
ending page: 21

In Vitro–In Vivo Correlation (IVIVC): A Strategic Tool in Drug Product Development
type: item
description: Abstract: In a recent era many concepts are dealing as an emerging tool for the drug delivery application like Biopharmaceutical Classification System (BCS), In-vitro and In-vivo study, and Bioavailability/Bioequivalence (BA/BE) study etc. To determine Therapeutic efficiency in-vitro is not enough so the concept of In-vitro-In-vivo correlation (IVIVC) is playing as an convincing correlation with this for concept of pharmaceutical dosage forms have been a main focus of attention of pharmaceutical industry, academia, and regulatory sectors. Formulation, Development and optimization of dosage form is an integral part of Research governed by technology transfer to scale up the manufacturing and then concurrent validation governed from the marketing of any therapeutic agent which is indeed a time consuming and costly process. A good correlation is a tool for predicting in-vivo results based on in-vitro data using IVIVC which gives indirect cost effective approach to dosage form optimization of trials in human, fixes dissolution acceptance criteria, and can be used as a tool to substitute for further bioequivalence studies; it is also recommended by regulatory authorities. Most correlations between in-vitro and in-vivo data (IVIVC) rely on linear relationships but sometimes it may not give linear behaviour due to some more factors in the actual in-vivo study. However, nonlinear IVIVC can be also observed, justified and validated. Thus the need for a tool to reliably correlate in-vitro and in-vivo drug release data has exceedingly increased. Such a tool shortens the drug development period, economizes the resources and leads to improved product quality. Increased activity in developing IVIVCs indicates the value of IVIVCs to the pharmaceutical industry. IVIVC can be used in the development of new pharmaceuticals to reduce the number of human studies during the formulation development as the main objective of an IVIVC is to serve as a surrogate for in vivo bioavailability a…
subject: Review Articles
  topic: section
creator: Vivek prakash bhai Chavda
creator: Dhaval Shah
creator: Hemal Tandel
creator: Moinuddin Soniwala
rights: Copyright (c)
date: 2017-01-18
publication date: 2017-01-18
starting page: 31
ending page: 54

Hepatic Disorders: Ayurvedic Perspective
type: item
description: Abstract Kamla is a very common disease in our country. It is difficult to diagnose. If properly diagnosed, the Sadhya: asadhyat (prognosis or curability and incurability) can be forecasted easily. The patient also can be informed what treatment is to be given. Varieties: Ayurvedic classics give two types of Kamla, viz Kosthashrit and Shakhashrit (caraka sutra while in chikitsa 16 maharishi Caraka has classified the same in two different names: (1) Koshtha: Shakhasrit and (2) Shakhashrit Kamla are given. Kamla can occur as a result of faulty treatment also; in other words Kamla can also be produced as an iatrogenic disorder also. Keywords: Kamla, Kosthashrit, Sadhya: asadhyat Cite this Article Nishant Shukla. Hepatic Disorders: Ayurvedic Perspective. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 55–59p.
subject: Review Articles
  topic: section
creator: Nishant Shukla
rights: Copyright (c)
date: 2017-01-18
publication date: 2017-01-18
starting page: 55
ending page: 59

A Brief Note On Different Concept Of Biowaiver
type: item
description: ABSTRACT The aim present work was to understand the concept of to waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA), Investigate New drug application (IND) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The current work focus different type of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, JP, WHO) or a combination of specific requirements. Keywords: Bioequivalence, Biowaiver, ANDA, NDA, INDA, BCS based Biowaiver. Cite this Article Mudit Dixit, Rohit Dixit, Ganaybn payya Bairy, et al. A Brief Note on Different Concept of Biowaiver. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 22–30p.
subject: Review Articles
  topic: section
creator: Mudit Dixit
creator: Rohit Dixit
creator: Vasanth Samaga
rights: Copyright (c)
date: 2017-01-18
publication date: 2017-01-18
starting page: 22
ending page: 30

Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing
type: item
description: Abstract Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical environment. eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. Since June 2003, applicants have had the option of submitting an eCTD in parallel with the paper submission (Common Technical Document), following sign-off by the International Conference on Harmonization Steering Committee of the eCTD Specification document at Step 4. It is designed to make regulatory submissions easier and more efficient for drug makers and for regulators. When it comes to eCTD submission, there continues to be differences among different countries and even ICH regions. The standardization that electronic submissions will bring will allow for much greater consistency not only for the regulators but also for organizations. It is important that eCTD ready documents are prepared by authoring them in eCTD compliant templates. If this is not undertaken, a large amount of the “publishing time” is spent in document reformatting. As the move from paper-based to eCTD submissions continues around the world, a multitude of challenges are to be faced regulatory departments. This paper describes eCTD History, Benefits of Implementing, Challenges, Modules, Risks involved in eCTD publishing and Quality Control. Keywords: Electronic Common Technical Document, Benefits, Challenges, Modules Cite this Article Praveen Agarwal, Anil Dewangan, Pavani Duggi. Electronic Common Technical Document (eCTD): A Review of History, Benefits of Implementing, Challenges, Modules and Risks Involved in eCTD Publishing. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 1–16p.
subject: Review Articles
  topic: section
creator: Praveen Agarwal
creator: Anil Dewangan
creator: Pavani Duggi
rights: Copyright (c)
date: 2017-01-17
publication date: 2017-01-17
starting page: 1
ending page: 16

Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC
type: item
description: Abstract A new reverse phase-high performance liquid chromatography (RP-HPLC) have been developed and validated for the determination of Erlotinib in bulk drug and pharmaceutical dosage form. The developed method is rapid, accurate, precise, simple and economical. The separation was carried out using column Hypersil ODS C-18 (150 mm x 4.6 mm 5 μm particle size) in isocratic mode, using mobile phase composition of 0.1% orthophosphoric acid: Acetonitrile in the ratio of 20:80 and PH adjusted to 4.0±0.1 with 1 M sodium hydroxide. The flow rate was 1.0 ml/min effluents are monitored at 245 nm. Chromatogram showed peak at a retention time of 2.706 min for Erlotinib. The method is validated according to ICH guidelines system suitability, linearity, precision, accuracy, specificity, ruggedness, robustness, LOD and LOQ. The calibration plot showed good linear relationship with r2 = 0.999 in the concentration range of 25-150 μg/ml for Erlotinib. The LOD and LOQ were found to be 1.07 μg/ml and 3.24 μg/ml. Accuracy was found to be 99.89%. Erlotinib was also exposed to acidic, alkaline, oxidative, thermal and photolytic conditions and the stressed samples were analyzed by the proposed method. Degradation studies showed that the Erlotinib was highly stable under acidic, alkaline, oxidative, thermal and photolytic conditions without change in RT values compared to standard and no significant degraded peaks were observed. The high percentage of stability under stress conditions confirms the suitability of the method for the determination of Erlotinib in pure and marketed formulations. Cite this Article K. Kalyani, V. Anuradha, Rlc. Sasidhar et al. Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 44–53p.
subject: Research Articles
  topic: section
subject: Erlotinib
  topic: keywords
subject: RP-HPLC
  topic: keywords
subject: validation
  topic: keywords
subject: Forced degradation studies
  topic: keywords
subject: ICH guidelines
  topic: keywords
subject: Drugs
  topic: subjects
subject: Pharmacy
  topic: disciplines
creator: K. Kalyani
rights: Copyright (c)
date: 2016-09-17
publication date: 2016-09-17
starting page: 44
ending page: 53

An Overview of GMP Requirements for Drug Product in China
type: item
description: Abstract Good manufacturing practice (GMP) is a tool which facilitates the innovation and continual improvement throughout the lifecycle of products and strengthens the link between pharmaceutical development and manufacturing activities. It also helps in increasing the process efficiency and product quality by adopting the current, risk-based manufacturing approach and in turn optimizes manufacturing process and improves quality of the end product which improves the health of the individual patient and the community. The main objective of this study was to compile the key GMP requirements for manufacture of generic product in China. Keywords: Good manufacturing practice (GMP), The State Food and Drug Administration (SFDA), China Cite this Article Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Drug Product in China. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 1–6p.
subject: Review Articles
  topic: section
creator: Jayant Kumar
creator: Achin Jain
creator: M. P. Venkatesh
rights: Copyright (c)
date: 2016-09-16
publication date: 2016-09-16
starting page: 1
ending page: 6

Formulation and Evaluation of Meloxicam Crystals Using Spherical Crystallization for Solubility Enhancement
type: item
description: Abstract The present study deals with spherical crystallization of Meloxicam crystals in order to improve the flow properties, compressibility and enhancement of dissolution characteristics of drug crystals. Spherical agglomerates of Meloxicam are prepared by different techniques. Selection of neutralization technique is based on the better percentage yield, drug content, and scanning electron microscopy (SEM) analysis. Optimization of Meloxicam spherical agglomerate was done. The micromeritic properties, solubility, in vitro drug release of spherical agglomerates were evaluated. Spherical agglomeration enhances the micromeritic and dissolution properties of Meloxicam. Optimized formulation of spherical agglomerate was chosen for the preparation of tablet. Response surface methodology using Box–Behnken was chosen for the optimization of spherical agglomerates. Spherical agglomerate tablet was prepared and evaluated and its dissolution characteristics were compared with conventional as well as marketed product. The tablet prepared from spherical agglomerate leads to a faster release of drug within 2 h when compared with marketed formulation. The drug release mechanism from the tablets was found to be non-Fickian kind of diffusion. Keywords: Meloxicam, solubility enhancement techniques, Box–Behnken, optimization, spherical agglomerate tablets Cite this Article Arun Raj R, Nandkishore K. Formulation and Evaluation of Meloxicam Crystals Using Spherical Crystallization for Solubility Enhancement. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 15–35p.
subject: Research Articles
  topic: section
subject: Meloxicam
  topic: keywords
subject: Solubility enhancement techniques
  topic: keywords
subject: Box – Behnken
  topic: keywords
subject: Optimization
  topic: keywords
subject: Spherical Agglomerate tablets.
  topic: keywords
subject: Pharmaceutics
  topic: subjects
subject: Pharmaceutical sciences
  topic: disciplines
creator: Arun Raj R.
creator: Nandkishore K.
rights: Copyright (c)
date: 2016-09-17
publication date: 2016-09-17
starting page: 15
ending page: 35

AN OVERVIEW OF GMP REQUIREMENTS FOR GENERICS IN BRAZIL AND RUSSIA
type: item
description: Abstract: The Implementation of GMP is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the Key GMP requirements for manufacturing of generics in Brazil and Russia, the two pharma emerging BRICS nation which in turn reduces the trade barrier for international commerce. It demonstrates industry support and regulatory authority’s commitment for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Key words: BRICS, GMP, generics manufacture, emerging market, ANVISA, Roszdranvadzor. Cite this Article Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Generics in Brazil and Russia. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 7–14p.
subject: Review Articles
  topic: section
creator: Jayant Kumar
creator: Achin Jain
creator: M. P. Venkatesh
rights: Copyright (c)
date: 2016-09-17
publication date: 2016-09-17
starting page: 7
ending page: 14

Pastillation—Towards Next Generation Particle Engineering
type: item
description: Abstract Particle engineering is quiet essential nowadays in order to get desired qualities for generating stable formulation with improved therapeutic credentials. The current pharmaceutical technology has already realized the tremendous potential of controlled release multiparticulate system in terms of its flexibility in product development and therapeutic benefits to the patients in comparison to the conventional single unit dosage form. Pastillation provides an efficient, cost-effective process for the continuous converting of molten products into uniform, round and dust free granules ideal for bagging, transporting and bulk material handling systems. This manuscript is grafted to provide some highlights regarding pastillation. Keywords: Pastillation, Rotoform®, AccuDrop®, Rollomat® Cite this Article Chavda VP, Berad T, Panara M, et al. Pastillation—Towards Next Generation Particle Engineering. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 36–43p.
subject: Review Articles
  topic: section
creator: Vivek P. Chavda
creator: Tushar Berad
creator: Mitesh Panara
creator: Jignesh Bhadani
creator: Sandip Patel
rights: Copyright (c)
date: 2016-09-17
publication date: 2016-09-17
starting page: 36
ending page: 43

Synthesis, Characterization and Pharmacological Evaluation of Amide Derivates of Prednisolone
type: item
description: Abstract In the present study, some novel amide derivates of prednisolone were synthesized as prodrugs. These novel prodrugs were also characterized with the help of usual analytical and spectral techniques (IR spectroscopy and NMR spectroscopy). These newly synthesized ester derivates of prodrugs were screened for their spectral techniques. All the above compounds showed significant anti-inflammatory effect at 50 mg/kg p.o. and the experimental data are statistically significant at p< 0.05 level. The pharmacological activities exhibited by synthesized novel compounds have confirmed that they may serve the purpose of being accepted as the novel therapeutic agents as anti-inflammatory agents. Keywords: Prednisolone, amide derivates, spectral techniques, anti-inflammatory Cite this Article Garg J., Kumar R. Synthesis, characterization and pharmacological evaluation of amide derivates of prednisolone. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 1–13p.
subject: Research Articles
  topic: section
creator: Jyoti Garg
creator: Raj Kumar
rights: Copyright (c)
date: 2016-03-17
publication date: 2016-03-17
starting page: 1
ending page: 13

Formulation and Evaluation of Microencapsulated Levofloxacin Gel
type: item
description: Abstract To treat various buccal infectious diseases, a sustained release microencapsulated levofloxacin gel was formulated. Levofloxacin microspheres were being prepared following o/w emulsion solvent evaporation technique by varying concentrations of ethyl acetate, ethyl cellulose and tween 80. Depending on their flow properties almost all the microspheres were found to be excellent. The drug-excipient compatibility study carried out using Fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC) resulted that the excipients used in the formulation are compatible to the drug used and with each other. However, the microspheres containing 2 g of drug in composition with 1.5% and 1.75% ethyl cellulose, 0.9% and 1% ethyl acetate, respectively, with 4% acetone were found to have more than 50% of drug-loading efficiency, hence optimized for further study. Finally, the optimized microspheres were incorporated within a conventional gel containing varying concentration of carbopol-934P. Conclusively, the optimized microcapsule-loaded gel formulations were evaluated for their physicochemical characters such as pH, viscosity and in vitro release study. All the optimized levofloxacin containing microcapsule-loaded gel formulations were found to possess desired pH and viscosity. Further, the in vitro drug release study showed that the levofloxacin containing microcapsule-loaded gel with 0.45% carbopol-934p was found to be the best formulation. Keywords: Microcapsulated gel, levofloxacin, FTIR, DSC, in vitro drug release Cite this Article Pattnaik S, Priyadarshini S, Niyogi P, et al. Formulation and Evaluation of Microencapsulated Levofloxacin Gel. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 39–47p.
subject: Research Articles
  topic: section
creator: Snigdha Pattnaik
creator: Sukanya Priyadarshini
creator: Partha Niyogi
creator: Laxmidhar Maharana
rights: Copyright (c)
date: 2016-05-20
publication date: 2016-05-20
starting page: 39
ending page: 47

Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Macrolide Immunosuppressant Substance and Drug Product
type: item
description: Abstract The present study describes a simple and stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for the quantification of the thermal degradation impurities of Tacrolimus (FK506) namely Ally ester rearrangement impurity (Impurity R) in Tacrolimus capsules and drug substances. Successful separation of impurity R from Tacrolimus, its other related substances and its tautomers were achieved on a Zorbax XDB C8 (150×4.6 mm, 5 μm) and detector of UV at 210 nm, 2.0 ml/min as a flow rate, and 20 μl as an injection volume. For the RP- HPLC method, 0.1% Trifluroacetic acid in water and Acetonitrile was used as a binary linear gradient and the column temperature was 55° C. Percentage recovery obtained in the range of 96.8%–101.2% and the method is linear for impurity R for specified concentration range with coefficient of variation (r) not less than 0.99. acid, base, oxidation, thermal and photolytic degradation have been carried in drug substance and drug product. The proposed RP-HPLC method was found to be specific, linear, precise, accurate and robust. Keywords: Tacrolimus, FK506, Thermal degradation impurity, Allyl ester rearrangement impurity, RP-HPLC Cite this Article J. Balaji, C. Nisha Shri. Development and Validation of RP-HPLC Method for Determination of Thermal Degradation Impurity in Tacrolimus Drug Substance and Drug Product. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 14–19p.
subject: Research Articles
  topic: section
creator: J. Balaji
creator: C. Nisha Shri
rights: Copyright (c)
date: 2016-05-20
publication date: 2016-05-20
starting page: 14
ending page: 19

Formulation Development of Otic In Situ Gel containing Lomefloxacin Hydrochloride
type: item
description: Abstract The present study was aimed at formulation development of a sustained release otic in situ gel of lomefloxacin hydrochloride for the treatment of chronic suppurative otitis media. Poloxamer 407 was used as the thermoreversible gelling agent. Poloxamer concentration in the range of 15–20% w/v was tried. Poloxamer 407 at 16% w/v gave satisfactory in situ gel forming formulations as it gelled near physiological temperature. Poloxamer 407 with various viscosity enhancing agents like methocel K100M, methocel K4M, carbopol 974P were tried in the range of 0.1–0.3% w/v. The formulations were evaluated for appearance/clarity, gelation temperature and gelling time, pH, rheological characteristics, drug content, in vitro drug release studies, ex vivo studies, release kinetics and stability studies. FT-IR spectroscopy was used to know drug and polymer incompatibilities. The viscosity of the formulations increased with increase in concentration of viscosity enhancers. In vitro release of selected formulations through synthetic membrane showed sustained release of drug over a period of 9 h. Ex vivo diffusion study for optimized formulation was also carried out through biological membrane. In case of pure drug, the release was more than 90% in 4 h and from in situ gel; the release was 55.38% at 9 h. Thus it can be a promising drug delivery system with sustained release and reduce frequency of administration providing better patient compliance. Keywords: Lomefloxacin hydrochloride, in situ gel, poloxamer 407, gelation temperature, viscosity enhancing agents Cite this Article Niyas A M, Narayana Charyulu R, Jobin Jose. Formulation Development of Otic In Situ Gel containing Lomefloxacin Hydrochloride. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 20–29p.
subject: Research Articles
  topic: section
creator: Niyas A. M.
creator: Narayana Charyulu R.
creator: Jobin Jose
rights: Copyright (c)
date: 2016-05-20
publication date: 2016-05-20
starting page: 20
ending page: 29

Supergenerics Regulation in India and US: A Comparative Review
type: item
description: Abstract ‘Supergenerics’, a new form of generic drugs with improved properties such as safety, efficacy, stability or improved commercial attractiveness such as taste or route of administration. Those drugs are most often based on an incremental re-formulation of a generic API (active pharmaceutical ingredient) or the combination of multiple generic APIs. Process of forming supergeneric molecule need not to be complex all the time. A supergeneric may be as simple as a more advanced delivery system that increases effectiveness or makes delivery simpler like forming a skin patch for a drug commonly given by parenteral route. Supergenerics have different regulations in different regions of the globe. In this review, an effort has been made to summarize the requirement for supergeneric in India and US in a comparative manner. Keywords: Supergenerics, New Drug, Patent extension Cite this Article Achin Jain, Mudit Dixit, Vasant Samaga et al. Supergenerics Regulation in India and US: A Comparative Review. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(1): 30–38p.
subject: Review Articles
  topic: section
creator: Achin Jain
creator: Mudit Dixit
creator: Vasant Samaga
creator: B. G. Bairy
creator: M. P. Venkatesh
rights: Copyright (c)
date: 2016-05-20
publication date: 2016-05-20
starting page: 30
ending page: 38