Pharmaceutics Articles

FORMULATION AND EVALUATION OF ATOMOXETINE HYDROCHLORIDE SUSTAINED RELEASE TABLETS

ABOUT AUHTORS
Seema Farheen1*, Shaik Zubair1 , Alwala Arpini1, Govindapuram Kalpana  Goud2,  Saidulu Soppari3, Mangulal Kethavath4
1Department  of pharmaceutics,
Vijaya College Of Pharmacy, Ranga Reddy, Telangana, India.
2Department  of pharmaceutical Analysis and Quality Assurance,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
3Department  of pharmacology,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India.
4Department  of pharmaceutics,
SLC’S College Of Pharmacy, Nalgonda, Telangana, India
*seemafarheen75@gmail.com

ABSTRACT
Atomoxetine hydrochloride (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Tablets of Atomoxetine Hydrochloride were formulated as sustained release tablet employing tamarind seed polysaccharide, guar gum, PVP, Mg. stearate, MCC  the sustained release tablets was investigated. Sustained release matrix tablets contain Atomoxetine Hydrochloride were developed using different drug polymer concentration of tamarind seed polysaccharide, guar gum,. Tablets were prepared by directly using MCC. Formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The resulting formulation produced robust tablets with optimum hardness, thickness consistent weight uniformity and low friability. All tablets but one exhibited gradual and near completion sustained release for Atomoxetine Hydrochloride, and 98.6% and 97.5 released at the end of 12 hrs. The results of dissolution studies indicated that formulation F8, the most successful of the study. An increase in release kinetics of the drug was observed on decreasing polymer concentration


A REVIEW ON QUALITY AGREEMENT REQUIREMENT IN PHARMACEUTICALS BY REGULATORY AUTHORITY IN COMPLIANCE TO CGMP GUIDELINES

ABOUT AUHTORS
Suleman S khoja*1,Sohil S khoja1, Farhad S Khoja2,Shamim S Khoja2, Narmin A Pirani2
1 Resource person in Pharmaceutical Quality Assurance and Facility Audit,
Vapi, Gujarat, India.
2 Registered Pharmacist, Gujarat State Pharmacy Council, Gujarat, India
*premukhoja@gmail.com

ABSTRACT
A quality agreement is a comprehensive written agreement between parties involved in the contract manufacturing of drugs that defines and establishes each party’s manufacturing activities in terms of how each will comply with CGMP. Quality agreements may be reviewed during inspections. A quality agreement describes the owner’s and the contract facility’s roles and manufacturing activities under CGMP. The quality agreement should explain how the contractor will report manufacturing deviations to the owner, as well as how deviations will be investigated, documented, and resolved in compliance with CGMP. Quality agreements should state that manufacturing services provided by contract facilities (including laboratories) will comply with CGMP. The most critical pieces are quality and change control, as described in the following sections. Manufacturing Activities Change Control Associated With Manufacturing Activities


NANO-PARTICLES CONTAINING ANTICANCER DRUG

ABOUT AUHTORS
Debpratim Chakraborty*, Nisha Lama Yolmo
Department of Pharmaceutical tech,
Jadavpur University,
Kolkata, West Bengal, India
*debpratim008@gmail.com

ABSTRACT:
Now a day in medical science and researches, cancer is one of the most life threatening disease but unfortunately still now we have no medical treatment for procurement of this disease. The pathology is not totally clear but according to medical evidence if we consider genes then we must agree that oncogene and tumor suppressor genes are mainly responsible. There are some risk factor also consider which may leads to cancer. The conventional treatments are surgery, Radio-therapy and chemo therapy but the real fact is none of the above mentioned treatment is enough for procurement of cancer and that’s why now scientist and researchers are thinking about nan-technology. NCI has identified that nano-technology have the potential to make paradigm changing impacts on the detection, treatment and prevention of cancer.  There are different strategies for cancer therapy using nano-particles like targeted and non-targeted nano-particles. Different studies show that the side effect of doxorubicine (an anticancer drug) can be minimizing by nano-technology, which also reduce the multi drug resistance. Nano-sphere and Nano-capsule of anti-steroid 4-hydroxytamoxifen RU reduce estrogen dependent tumor. Dendritic nano-technology with 5-fluro Uracil decreases the drug clearance and increase the therapeutic time. Methotrixate incorporated dendritic polymer target the folic acid receptor. Camptothecin loaded nano-particles show longer plasma retention, high and longer tumor localization. Nano-particles prepared by poly-lactic-co-glycolide increase the half life of Cisplatin. Paclitaxel, a microtubule-stabilizing agent that promotes polymerization of tubulin causing cell death by disrupting the dynamics necessary for cell division, is effective against a wide spectrum of cancers. Miscellaneous agent like Arsenic trioxide, Butyric Acid, Diethylene-triamine-Acetic acid show more prominent activity. Recent development in nanoparticle-based combination therapy have shown several unique features that are untenable in traditional chemotherapy. Drug combinations can now be optimizedand cleverly delivered in a more effective way.


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.


IN-VITRO ANTIPROLIFERATIVE ACTIVITY OF M. AZEDARACH

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 ABOUT AUHTORS
Deepak Chowrasia1*, Nisha Sharma1, Mohammad Arshad2
1 University Institute of Pharmacy,
CSJM University, Kanpur, U.P., India
2Molecular Endocrinology Lab, Department of Zoology,
Lucknow University, Lucknow, U.P., India
* chowrasia.deepak@gmail.com

ABSTRACT
Preliminary screening of different crude extract of. M. azedarach was evaluated against human cancer cell lines viz. MCF-7 (breast cancer), SaOS-2 (osteosarcoma), and A431 (epidermoid carcinoma) to search for better herbal based anticancer agent. Solvents used were water, methanol, ethanol, n-butanol, & n-hexane. It has been found that among solvents, methanolic extract of M. azedarach shows comparatively superior activity suggesting presence of phytoconstituents comprising polar functionalities.


SOLID DISPERSION- A REVIEW

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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

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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

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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.


EFFECT OF ASCORBIC ACID ON DISSOLUTION STABILITY OF RIFAMPICIN IN MARKET FIXED DOSE COMBINATION PRODUCTS FOR TUBERCULOSIS

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ABOUT AUTHORS
Subashini Rajaram, Abirami Murugan, Nidhina Raj C.M
Swamy Vivekanandha College of Pharmacy, Namakkal, Tamilnadu, India.
Life Pharmacy, Al Barsha, Dubai-UAE
subababu.r@gmail.com

 

ABSTRACT
Degradation of rifampicin (RIF) to insoluble and poorly absorbed 3-Formyl rifamycin SV (3-FRSV) in acidic environment is a major concern which leads to reduction in the bioavailability of RIF and is further influenced by the presence of isoniazid (INH) in the stomach after ingestion. It is recommended that addition of ascorbic acid (ASC) in dissolution medium, in plasma as antioxidant to stabilize RIF from degradation and also daily intake of ASC to control tuberculosis (TB).Though the effect of ASC on fixed dose combination (FDC) products has not been traversed and hence examined in the present study.  The rate of degradation of RIF to 3-FRSV in the presence of ASC in dissolution medium (0.1 N HCl) on market formulations was estimated by Dual Wavelength UV–Vis. spectrophotometry (DW spectrophotometry) and High performance liquid chromatography (HPLC) method. Addition of ASC in FDC formulations lowered significantly formation of 3-FRSV or degradation of RIF as compared to that without ASC in in-vitro. Our study proposed that co-package of ASC with fixed dose combination products (FDC) can protect RIF degradation in the acidic environment and in-vivo investigation needed to predict the bioavailability of RIF in FDC products in the presence and absence of ASC for effective control of TB.


PREPRATION AND EVALUATION OF NANO-EMULSION FORMULATION BY USING SPONTANEOUS EMULSIFICATION

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ABOUT AUTHORS
Deepa Vishwakarma, Deepa Dhiman, Amit kumar Pal, Aman Mittal, Sunit Saini
Department of Pharmacy,
Smt. Tarawati Institute of Biomedical Allied Sciences,
Roorkee, Uttarakhand, India

vishwakarmadeepa152@gmail.com

ABSTRACT
The objective of our investigation was to design a thermodynamically stable and dilutable nanoemulsion formulation of Ibuprofen, with minimum surfactant concentration that could improve its solubility, formulation were taken from thermodynamic stability and dispersibility test. The oil, surfactant, co-surfactant and aqueous phase, respectively, containing 100mg of ibuprofen showed a significant improvement in drug release. In vitro drug release of the nanoemulsion formulation was highly significant as compared to marketed tablet formulation. The present study revealed that tinidazole nanoemulsion could be used as a liquid formulation for increase bioavailability. The formulated system can also be treated as self nano emulsifying drug delivery system.


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