Pharmaceutics Articles

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

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

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.


FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE BUCCAL PATCH

ABOUT AUTHOR
S. Z. Chemate, Vaishali N. Garje*, Shubhada A. Gayake
Department of Pharmaceutics,
Padmashri Dr. Vithhalrao Vikhe Patil Foundation’s College of Pharmacy,
Ahmednagar, Maharashtra, India
*garjev@gmail.com

ABSTRACT
The aim of present investigation was to design and evaluate, mucoadhesive buccal patch of Metformin hydrochloride, a BCS class II drug, to provide unidirectional sustained drug delivery to the buccal mucosa that has potential to enhance the bioavailability. The patches were prepared using HPMC K4M as a polymer, polyethylene glycol 400 as a plasticizer, by solvent casting technique. The patches, which were prepared by the solvent casting method, were smooth and elegant in appearance; were uniform in thickness, weight and drug content; showed no visible cracks; and showed good folding endurance. The amount of polymer, which significantly influenced characteristics like swelling index, mucoadhesive strength, diffusion study


REGULATORY CANVAS OF INDIAN PHARMACEUTICAL INDUSTRY: CHALLENGES AND FUTURE

ABOUT AUTHORS
Ayushi Srivastava*, Veena Gupta
QC Department,
Akums Drugs & Pharmaceuticals Ltd, Haridwar, India
*ayushisr@gmail.com

ABSTRACT
This article undertakes a review and assessment of regulatory framework in the Indian pharmaceutical industry. Understanding the regulatory circumstances in this segment is extremely critical. The Pharmaceutical industry is one of the major industries in India and it contributes a large share in the overall macro level growth of the India. It is one of the most dynamic sectors in the country but its compliance structure is more complex. The pharmaceutical industry has always been a buoyant sector in the eyes of Investors. With increasing returns, lower risks and high growth, investors are more interested in this industry than ever before.


A REVIEW ON: PRESERVATIVES USED IN PHARMACEUTICALS AND IMPACTS ON HEALTH

ABOUT AUTHORS
Sabir M. Shaikh*1, Rajendra C. Doijad1, Amol S. Shete1, Poournima S. Sankpal2
1 Department of Pharmaceutics, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
2 Department of Pharmaceutical chemistry, Shree Santkrupa College of Pharmacy, Ghogaon, Karad, Maharashtra, India.
*sabirmshaikh17@gmail.com

ABSTRACT
For several decades pharmacist have been aware of the need to protect their products against microbial contamination but it is only during the last one or perhaps two decades the serious thought of has been applied to the science of preservation. Preservatives are commonly used as additives in pharmaceutical products, food and cosmetics. Some of the liquid preparation are susceptible to microbial contamination because of the nature of ingredients present in it. Such preparation are protected by preservatives which avoids degradation and alteration of the product.A preservative is a natural or synthetic chemical added to various products which helps to prevent microbial decomposition. Present article deals with the study of ideal properties, classification, mechanism of action, Pharmaceutical applications and its impact on health of various preservatives used in pharmaceuticals.


RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF MEBENDAZOLE IN API AND PHARMACEUTICAL FORMULATIONS

ABOUT AUTHORS
Durgesh Rameshlal Parakh1*, Jayshri K. Madagul1, Harshad Rajendra Mene2, Moreshwar P. Patil1, Sanjay J. Kshirsagar1
1
Department of Pharmaceutics,
MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, India.
2
Department of Pharmaceutics,
Government College of Pharmacy, Osmanpura, Aurangabad, Maharashtra, India.
*aryanparakh57@gmail.com

ABSTRACT
A new simple and sensitive RP-HPLC method was developed and validated for quantification of Mebendazole in Active Pharmaceutical Ingredient (API) and pharmaceutical formulation.The gradient RP-HPLC method was developed on Agilent (India) C18 250 × 4.6 mm, 5 μ column using mobile phase as acetonitrile: water pH 3.0 with orthophosphoric acid (90:10 v/v) at a flow rate of 1 mL/min and detection was carried out at 234 nm using UV-Visible detector (UV 3000 M). The method was validated linearity, limit of detection, limit of quantification, precision, ruggedness, robustness, accuracy and specificity were found to be satisfactory. The method was found to be linear in the concentration range of 20-100 μ/mL with correlation coefficient of 0.999. The method was validated according to the ICH guidelines and was proved to be specific, linear, accurate, precise and economical for the analysis of Mebendazole.


DATA INTEGRITY AND WORLDWIDE REGULATORY GUIDANCE

ABOUT AUTHORS
Rohit A. Patil1*, Shruti N.Patil2

Department of Regulatory Affairs,
Supreme Pharma Healthcare Pvt. Ltd. Mumbai, MH, India
* rohitpharma3250@gmail.com

ABSTRACT
Good storage of data & record management are critical elements of pharmaceutical quality system. Data integrity refers to maintaining & assuring the accuracy & consistency of data over its entire life –cycle in compliance with its applicable regulatory requirements.
Data integrity is mandatory for the regulated pharmaceutical industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Data integrity risk should be assessed, mitigated, communicated & reviewed throughout the data life cycle. Healthcare industries should be designed Record-keeping methodologies and systems, in a way that encourages compliance and assures data quality and reliability.


Pages

FIND MORE ARTICLES