Pharmaceutics Articles

QUALITY BY DESIGN (QbD) IN PHARMACEUTICAL INDUSTRY: TOOLS, PERSPECTIVES AND CHALLENGES

ABOUT AUTHORS
Arijit Gandhi*1, Chandrani Roy2
1 Production cum Quality Manager, Kras Pharmaceuticals Pvt. Ltd., Fatwah, India.
2 Department of pharmaceutics, Gupta College of Technological Sciences, West Bengal
arijit.babugandhi.gandhi@gmail.com

ABSTRACT
Recently the concept of “Quality by Design” (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based, holistic and proactive approach for development of pharmaceutical product. It mainly covers designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include defining target product quality profile, designing product and manufacturing processes, identifying critical quality attributes, process parameters, and sources of variability & controlling manufacturing processes to produce consistent quality over time The purpose of this article is to discuss the concept of pharmaceutical Quality by Design and describe how it can be help to ensure pharmaceutical quality & drug development.


SPECIFICATIONS FOR STARTING MATERIALS, INTERMEDIATES AND FINISHED PRODUCTS

ABOUT AUTHORS
Nirav R.Soni, M.Pharm
A-one Pharmacy college,Enasan
Dept.of Qualtiy Assurance (QA)
nirav_sonic@yahoo.com

ABSTRACT
The specifications are to assure that each unit has the value of drug claimed on the label, that all the drug in each unit is out there for whole use ,that the drug steady  within the formula in its certain final container for their expected shelf life and it’s having no toxic overseas substance. It’s greatly utilized in pharmaceutical enterprise and utilized by using wellness sector and support best which is finished via GMP, GLP and GCP and other organization including Pharmaceutical Quality System (PQS) , Quality Risk Management (QRM)  and Quality by Design (QbD).


A COMPARATIVE PHARMACOLOGICAL STUDY OF DIURETIC DRUGS

ABOUT AUTHORS
Bharat Lal Naik, Chaitanya Prasad Meher
Department of Pharmacology
The Pharmaceutical College (TPC), Tingipali, Barpali, Odisha
chaitanyameher84@gmail.com

ABSTRACT
Diuretic are the drugs that promote the output of urine excreted by kidney. The increased excretion of water & electrolytes by the kidney is dependent on 3 different process viz. glomerular filtration, tubular reabsorption & tubular secretion. Diuretic are very effective in the treatment of cardiac oedema, specifically the one related  with congestive heart failure(C.H.F). They are extensively used in various type of disorders for ex. Cirrhosis of liver, Hypertension,Nephritic syndrome, diabetes insipidus, nutritional oedema, oedema of pregnancy & also to lower intraocular & cerebrospinal fluid pressure. The presented article is based on comprehensive idea about the pharmacology of various diuretic drugs.


A comparative evaluation of the quality & price of generic medicine with their branded counterparts

ABOUT AUTHORS
Bhupender Singh, Arun Nanda, Vikaas Budhwar, Rakesh K. Marwaha
Department of Pharmacy,
M. D. University, Rohatak
Haryana, India

* pharma.bsingh@gmail.com

ABSTRACT
Generic drugs are as effective as their branded counterparts in terms of safety and efficacy. Although their exists several myths about quality of generic medicines because of its less price as compared to branded counterparts. The present study aims to evaluate and compare the quality of generic medicine with their branded counterparts as per Indian Pharmacopoeial standards and other validated methods on a commonly used type 2 diabetes drug (Metformin). The qualitative as well as quantitative studies were performed as per IP 2010. The official test performed includes uniformity of weight, disintegration, dissolution, assay and friability. Non official test includes hardness test and assay by HPLC using validated methods. The study revealed that branded as well as generic metformin tablets comply with the standards provided in IP 2010 and generic metformin was found to be 111.52% lesser in cost per tablet as compared to costliest branded version of metformin.


FORMULATION AND EVALUATION OF ORO DISINTIGRATING TABLETS OF RESPERIDONE BY USING SUBLIMATION AND SOLID DISPERSION TECHNIQUE

ABOUT AUTHORS
V.T. Iswariya*, A.Hariomprakash Rao, K. Sri Jahnavi, A.Sravanthi, P. Deepa, K. Samatha
M.R.R. College of Pharmacy,
Nadergul, Andhra Pradesh, India
*iswariyapharma@gmail.com

ABSTRACT
The technique of Solid dispersion and sublimation techniques are a promising method towards enhancing the dissolution of poorly soluble drugs. The main objective of Resperidone mouth dissolving tablets is to enhance the solubility. Several formulations of solid dispersion and sublimating tablets were prepared by using different ratio of drug sublimating agent (Camphor) and carriers (PEG 4000, Polaxomer, Mannitol). The prepared Solid dispersion and sublimating tablets were evaluated for their flow properties such as bulk density, tapped density, angle of repose, Carr’s index and Hausner’s ratio. The interaction between drug and excipients were studied by FTIR. In vitro dissolution profiles of the solid dispersion and sublimation formulations were studied and compared between sublimation and solid dispersion formulation. Among all formulations SD2 formulation was shown maximum drug release in less time.


CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY - AN OVERVIEW

ABOUT AUTHORS
Sadanand Maurya*1, Devendra Goyal2, Chandan Verma1
1 Department of Quality Assurance in Macleods Pharmaceutical Limited
2 Department of Production in Macleods Pharmaceutical Limited
*sadanandmpharma@gmail.com

ABSTRACT
Manufacturing of Pharmaceutical products shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important role. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Pharmaceutical manufacturers must validate their cleaning process to ensure compliance with cGMP regulations. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. In this article cleaning validation and cleaning validation program discussed in brief.


DEVELOPMENT AND IN-VITRO DRUG RELEASE PROFILE OF SUSTAINED RELEASE FLOATING GRANULES OF CINNARIZINE

ABOUT AUTHOR
Aman Mittal
Smt. Tarawati Institute of Biomedical & Allied Science
Roorkee, Uttarakhand, India
amanmittal_27@yahoo.com

ABSTRACT
Floating drug delivery systems (FDDS) are the drug delivery systems having a bulk density lower than the gastric content and they remain buoyant in the stomach for a prolonged period of time, with the potential for continuous release of drug. Cinnarizine, a H1-receptor antagonist, used for the treatment for vestibular vertigo disorders and motion sickness was selected as the drug aspirant and Gelucire 43/01 was selected as a lipid carrier in different ratio (1:0.5, 1:1, 1:1.5) along with drug to be formulated as gastro retentive multiparticulate system. The formulation F1 to F9 were prepared and formulation F4 to F9 were evaluated for in-vitro drug release and formulation F5 was selected as optimized formulation that exhibited good floating ability and zero order drug release (93.56 %) at the end of 8 hrs. The in-vitro drug release study of the aged sample show phase conversion of Gelucire. The phase conversion also caused increase in drug release. In conclusion, hydrophobic lipid, Gelucire 43/01 can be considered as an effective carrier for design of a multiple unit floating drug delivery system of cinnarizine.


RECENT INDUSTRIAL DEVELOPMENT IN ORAL THIN FILM TECHNOLOGY: AN OVERVIEW

ABOUT AUTHORS
Kh. Hussan Reza 1*, Pranabesh Chakraborty2
1 Department of Pharmacy, Bengal School of Technology, Sugandha, Hooghly, West Bengal
2 Director, Department of Pharmacy, Bengal School of Technology, Sugandha, Hooghly, West Bengal
*hassan23pharma@gmail.com

ABSTRACT
Oral route of administration is most convenient route but often is disadvantageous for administering to geriatric and paediatric patients. Orally disintegrating film is found to be effective in delivering rapid drug action by dissolving the drug in buccal cavity. Since a decade oral thin films has got commercial importance in generic and non generic market projecting it as a multinational business asset. Current research in this field is found to be associated with industrialization and commercialization. Current article make an overview of not only technological changes in research and manufacturing but also gives an insight about growing market worldwide.


FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS TO ENHANCE DISSOLUTION RATE OF LAMOTRIGINE BY USING SOLID DISPERSION TECHNIQUE

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ABOUT AUTHORS
Bhumi B. Patel1*, Chainesh N. Shah2, Rumit M. Shah3
1Department of Pharmaceutics, Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh, Gujarat, India.
2 Department of Pharmacy, Sumandeep Vidyapeeth, Piparia, Gujarat, India
3 Department of Pharmacognosy, Shree Naranjibhai Lalbhai Patel College of Pharmacy, Umrakh, Gujarat, India.
* patelbhumi198@gmail.com

ABSTRACT
Lamotrigine belongs to biopharmaceu­tical classification systems; BCS class II (Low solubility & High permeability). In addition, it requires immediate therapeutic action. Hence, the main objective of this study is to improve the solubility by solid dispersion technique and formulate it as Orodispersible tablets to avert the problems of swallowing and to provide rapid onset of action. Lamotrigine solid dispersion was prepared by using PEG 6000 as solubility enhancers and formulated it into ODT by direct compres­sion technique using different concentrations of Sodium Starch Glycolate, Cross Carmalose Sodium, and Kyron T-314 as cross linked polymers. The tablets were evaluated for various parameters and the results were found to be sat­isfactory. The batches batch containing Kyron T-314 as super disintegrant in 7% concentration, as they showed 95.75% drug release in 15 minutes with a disintegration time of 11 seconds which shows improved dissolution rate in compare to marketed formulation of Lamotrigine.


A REVIEW ON GASTRORETENTIVE DRUG DELIVERY SYSTEMS

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ABOUT AUTHORS
Hemendrasinh J. Rathod*, Dhruti P. Mehta, Jitendra singh Yadav
Department of Pharmaceutics,
Vidyabharti Trust College of Pharmacy,
Umrakh, Gujarat, India.
* hariomh.j.rathod@gmail.com

ABSTRACT
The purpose of writing the review on gastroretentive drug delivery systems (GRDDS) was to accumulate the current literature with a special emphasis on several gastroretentive approaches that have recently become important methodologies in the field of site-specific orally administered sustained/controlled release drug delivery. Technological efforts have been made in research and development of rate-controlled oral drug delivery systems to solve physiological difficulties, like short gastric residence times (GRT) and unpredictable gastric emptying times (GET). GRDDS are an approach to prolong the GRT, thereby targeting site-specific drug release in the upper gastrointestinal tract (GIT) for local or systemic effect. Conventional oral dosage forms pose low bioavailability problems because of their quick gastric transition from the stomach, particularly in case of drugs that are less soluble at an alkaline pH of the intestine. Also, drugs that produce their local action in the stomach get quickly emptied and don’t get sufficient residence time in the stomach. Several efforts have been made to extend the retention time of drug delivery system to reduce the frequency of dose administration. GRDFs not only prolong dosing intervals, but also increase patient compliance beyond the level of existing controlled release dosage forms. This article gives an overview on advantages, disadvantages and characterization of gastroretentive drug delivery systems. This review also includes commercially available gastroretentive products and patents.


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