Pharmaceutics Articles

FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF MOUTH DISSOLVING TABLETS OF PIOGLITAZONE HYDROCHLORIDE

ABOUT AUTHORS
Kambham Venkateswarlu*, Jami Komala Preethi
1Department of Pharmaceutics, JNTUA-Oil Technological and Pharmaceutical Research Institute, Jawaharlal Nehru Technological University Anantapur, Ananthapuramu, Andhra Pradesh, India.
k.v.reddy9441701016@gmail.com

ABSTRACT
The present investigation was focussed on formulation and in vitro evaluation of mouth dissolving tablets (MDTs) of Pioglitazone Hydrochloride (PGTZN) thereby enhancing the dissolution rate. MDTs were prepared by wet granulation and direct compression methods using Croscarmellose sodium, Crospovidone and Sodium starch glycolate as superdisintegrants. Powder blends were evaluated for flowability and all the powder blends showed acceptable flowability. The prepared tablets were evaluated for post compression parameters like hardness, friability, wetting time and showed acceptable results. Formulations F8 and F15 showed disintegration time of 23 and 22 sec respectively. Dissolution was performed in pH 1.2 HCl buffer and formulations F15 showed maximum drug release within 30 min. drug release from F15 was more than that of the marketed drug. Hence, it could be concluded that formulation F15 showed good drug release than marketed drug and there is a lot of scope for future in vivo studies.


A REVIEW ON PROCESS VALIDATION

ABOUT AUTHORS
Surya Pratap Singh *, Kailash Dhaker, Abhisek Namdev, Mahaveer Prasad Khinchi, Surbhi Bhatnagar
1Department of pharmaceutics, Kota College of  Pharmacy,
Kota, Rajasthan, India
sp.kota91@gmail.com

ABSTRACT
Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Basically, Process validation emphasize the role of objective measure and statistical tools and analyses knowledge ,detection ,and control of variability and give assurance on consistent of quality / productive throughout life cycle of product. Result from Process validation method can be used to judge the quality and consistency of analytical result. The purpose of this review to cover need of process validation, principle of process validation, type of process validation, phase of process validation, strategy for process validation. In this review article we discussed about the importance and strategy of validation of analytical procedure.


MICROENCAPSULATION DRUG DELIVERY SYSTEM - AN OVERVIEW

ABOUT AUTHORS
Keshari Roshan*, Rathore KS, Bharkatiya Meenakshi, Mishra Amul
Bhupal Nobel’s Institute of Pharmaceutical Sciences,
Udaipur, Rajasthan, India.

*Roshankeshari220@gmail.com

ABSTRACT 
 Microencapsulation is a process in which a very tiny droplet of particle such as solid, liquid or even gas can be entrapped, coated or surrounded with a polymeric particle. There are different technique to encapsulate the material by chemical method which includes coacervation method, polymeric-polymeric incompatibility, and physical method which include air suspension method, pan coating, spray drying, and centrifugal extrusion. The main important material used in microencapsulation is core material (which is specified material to be coated) and coating material (which is capable of forming film).since it is applicable in pharma industry, agriculture industry, food industry, construction industry. As it is better drug delivery system than conventional drug delivery system with minimum side effect and having targeted action.


A REVIEW ON USFDA WARNING LETTER AND VIOLATION OBSERVED IN PHARMACEUTICAL INDUSTRY

ABOUT AUTHORS
Suleman S. khoja 1, Sohil S khoja
1,Parthkumar H chauhan 2,Farhad S Khoja
1Resource person in pharmaceutical quality assurance ,VAPI, Gujarat.
2Resource person in quality assurance ,NAVSARI, Gujarat.
3Registered Pharmacist ,VAPI, Gujarat.
premukhoja@gmail.com

ABSTRACT
A review on USFDA observation and finding while inspection of Pharmaceutical the present review provide some important , Significant observation and measure of compliance.USFDA is an regulatory body governing health products which are made ( in or  outside USA) and marketed in united States of America. Significant deviation from cGMP and Significant violation from cGMP for both API Facility and formulations .strictly compliance requirements under 21 Code of federal regulations (CFR). FDA observation includes but not limited to this. If not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the Safety, Identity, Strength, Purity and Quality of drug product (SISPQ) ,violation under [ 21 CFR & 211.67 (a) ]. Data integrity is main issue Raised in most FDA warning letter. Corrective action and plan. Level of control must be raised from raw material, packaging material (Accurate, Legible, Contamptarious, Original, Attributable (ALCOA)) in process, finished dosage form, Maintain log book properly. Guidelines for Out of specification(OOS ) and out of trends(OOT)  must be follow if any required.


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

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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.


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