Pharmaceutics Articles

SOLUBILITY ENHANCEMENT OF POORLY WATER SOLUBLE DRUG BY SPHERICAL CRYSTALLIZATION TECHNIQUE

ABOUT AUHTOR
HardikRana*, BhargavVaghasiya, MansiDholakia
Department of Pharmaceutics,
Anand Pharmacy College, Anand, 388 001, Gujarat, India.
*hardikrana1439@gmail.com

ABSTRACT
The objective of present study was to enhance the solubility of poorly soluble drug Ibuprofen using spherical crystallization technique.The potential agglomerates were prepared by addition of different concentrationof polymer selected on the basis of Phase solubility study. Spherical agglomerates were prepared using diethyl ether as bridging liquid by neutralizing technique, spherical agglomeration technique, Quasi emulsion solvent diffusion technique. Spherical agglomerates were evaluated for morphology, production yield, drug content, particle size and dissolution behaviour compared with pure drug.The result of phase solubility studies revealed that there is enhancement of solubility by PEG 4000. Rod shaped crystals of pure drug converted to spherical was confirmed by optical microscopy. The dissolution of agglomerates of optimum batch exhibited 88.24% release compare to 47.18% of pure drug within 60 minute. This study demonstrated that spherical crystallization technique can be consider as a suitable alteration of granulation. Ibuprofen spherical agglomerates can be prepared with PEG 4000. It exhibited excellent physicochemical, solubility, dissolution rate in comparison with pure drug. Among other spherical crystallization technique, QESD proved to be excellent techniquefor enhancement of solubility and dissolution.


SOLID DISPERSION- A REVIEW

ABOUT AUTHORS
Bhumika Kumar*
Department of pharmaceutics,
Delhi pharmaceutical sciences and research university,

New Delhi, India

ABSTRACT
Solid dispersion is an effective way of improving the dissolution rate of poorly water soluble drugs and hence its bioavailability.  The water soluble carriers used in preparation of solid dispersion enhance the dissolution rate of the poorly water soluble drug. The review article focuses on the methods of preparation, advantages, disadvantages and characterization of the solid dispersions.


VALIDATION-IN PHARMACEUTICAL INDUSTRY : CLEANING VALIDATION - A BRIEF

ABOUT AUHTORS
Jaha Sultana Mohammed
Pelcat Formulation PVT
sohnivya786@gmail.com

ABSTRACT
The purpose of cleaning validation is to establish the documented evidence with high degree of assurance that the cleaning process followed as per standard operating procedure for cleaning the equipment used for the processing, consistently and concurrently yields the results not exceeding predetermined acceptance limit. The main objective of this particular study is to develop some understanding for the process of validation and its type along with importance of cleaning validation in pharmaceutical industry to prevent cross contamination. This topic includes Types of validation, cleaning validation, Levels of cleaning Validation, Cleaning mechanisms, cleaning agents used and process followed by pharmaceutical industry to achieve cleaning validation. The various methods used for cleaning validation are clearly discussed in this review.


A REVIEW ON GASTRO-INTESTINAL DRUG ESOMEPRAZOLE

ABOUT AUHTORS
MNL Aishwarya, E. Anka Rao, M. Niranjan Babu
Department of Pharmaceutics
Seven Hills College of Pharmacy, Tirupati, AP, India
meenumakkhan@gmail.com

ABSTRACT
Esomeprazole is a proton pump inhibitor used to treat gastric problems mainly peptic ulcers. Peptic ulcers are present in around 4% of the population. They newly began in around 53 million people in 2013. About 10% of people develop a peptic ulcer at some point in their life.They resulted in 301,000 deaths in 2013 down from 327,000 deaths in 1990. The first description of a perforated peptic ulcer was in 1670 in Princess Henrietta of England. H. pylori was first identified as causing peptic ulcers by Barry Marshall and Robin Warren in the late 20th century, a discovery for which they received the Nobel Prize in 2005. Esomeprazole comes under non-surgical treatment for peptic ulcers. Though it is an effective drug used for the treatment of peptic ulcers it includes some side effects such as headache, nausea, diarrhea, decreased appetite…etc., optical isomer of omeprazole is called as s-isomer of omeprazole or esomeprazole which is an improved form of omeprazole. Esomeprazole in combination with cardiovascular drugs produces potential interactions and positive effects. This review article provides an evaluation of the literature on the concomitant use of esomeprazole available. The efficacy, safety, tolerability, cost effectiveness, and patient quality of life of this regimen is discussed. A summary of the pharmacokinetic and pharmacodynamic interactions of esomeprazole, Mechanism of action of omeprazole, as well as its effects during pregnancy are also reviewed.


PREPARATION METHOD, PROPERTIES AND CROSSLINKING OF HYDROGEL: A REVIEW

ABOUT AUTHORS
Komal Saini*
Department of Pharmaceutics, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh
komalsainiks@gmail.com

ABSTRACT
Hydrogels comprises of different classes class of materials that could absorb considerable amount of water while maintaining their integrity in water having three dimensional, hydrophilic, polymeric networks. In the last few years, radical methods of preparation of hydrophilic polymers and hydrogels have evolved that may be used in the future in drug delivery applications. For successful and desirable applications, synthesis of new polymers and cross-linkers having more biocompatibility and better biodegradability would be beneficial. This review provides an overview of the different classes of hydrogels, their characterization, method of preparation, their advantages and disadvantages and cross-linking.


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

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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

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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

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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

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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

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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.


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