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.


DRUGS AND INTELLECTUAL PROPERTY RIGHTS: POSITIVE AND NEGATIVE ASPECTS

ABOUT AUTHORS
J A Sathwara1, A M Bhandari2
1* Department of Pharmacology, A.R.College of Pharmacy & G.H.Patel Institute of Pharmacy, Anand ,Gujarat
2 Department of Clinical Pharmacy, A.R.College of Pharmacy & G.H.Patel Institute of Pharmacy, Anand ,Gujarat

*jignasa.sathwara@gmail.com

ABSTRACT
The development of drugs is costly for the Pharmaceutical companies and without the protection of Intellectual Properties, the formula for the drug can easily be duplicated and can be synthesized at cheaper cost. The U.S. intellectual property laws protect the rights of small inventors and large corporations alike to guarantee “the first to invent” the exclusive right to the patents. To solve the drug price inflation within the U.S., an initiative has been taken that drug patents are different from other innovations. Under the new plan, new drugs would be sold at generic prices upon FDA’s approval. New drugs will no longer be rewarded by net-profit from sales, but instead by Medical Innovation Prize Fund at a level of 0.5% of the gross domestic product, that provide money to developers of new products based upon the actual impact on health outcomes over ten years. Although patents protect the rights of the investors and courage innovations, there are certain ideas that should not been patented. Potentially lifesaving technologies should be separated from other type of innovations, and money making should not be the only inceptive for drug discovery. The number of worldwide who have access to medicines is low, an allowing patents on drugs, although increase the number of advancements in lifesaving technologies; it will decrease the number of people who access to them. International efforts should focus on allocating monetary motivation to provide people to access drugs.


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.


A COMPARATIVE STUDYOF CENTRAL ANALGESIC ACTIVITY OF POTENTIAL ANTIDEPRESSANTS

ABOUT AUTHORS
S. VISWANTH REDDY*, G.AVINASH1, R. SAGAR2
PNR College of Pharmacy,
Shadnagar, Mahaboob Nagar (Dist), Telangana
vishwanth555@gmail.com

ABSTRACT
Pain is an ill defined, disabling accompaniment of many medical conditions. It is often evoked by an external and internal noxious stimulus. It affects millions of people suffering with depression and other psychiatric disorders. Most of the antidepressants are having analgesic capacity to treat the pain by inhibiting nociceptive stimuli by increasing the seratonergic and noradrenergic transmission in CNS.

Objectives
The Present study carried out to investigate the central analgesic activity of potential antidepressants like Fluoxetine, Imipramine, Amitriptyline and to compare the analgesic activity with standard central analgesic Pentazocine.

Methods
Analgesic activity was evaluated by using hot plate and tail immersion models in mice. Fluoxetine (10 mg/kg), Imipramine (20 mg/kg), Amitriptyline(20 mg/kg) were used as test drugs and Pentazocine (10 mg/kg) was used as standard drug. 

Results
In tail immersion model of analgesic activity Fluoxetine possess significant analgesic activity (*p<0.05 at 60 min interval, ***p<0.001 at 90 and 120 min interval) Amitriptyline also showed significant analgesic activity (**p<0.01) at 90 min interval and ***p<0.001 at 120 min interval. Imipramine is the least effective analgesic in this study showed mild analgesic activity (*p<0.05 at 90 min interval and **p <0.01 at 120 min interval).

In hot plate analgesic model Fluoxetine and Amitriptyline possess significant analgesic activity (***p<0.001 at 120 min interval), Imipramine same like above said model less effective, doesn’t shown significant analgesic activity.

Conclusion
All the test drugs significantly reduce the painful stimuli when compared to the control group in both the models. These results suggest that the antidepressants which increase the monoamine transmission in the brain posse’s significant antidepressant activity and might be useful as potent analgesics.


EVALUATION OF DOOR TO NEEDLE TIME AND PREDISPOSING FACTOR TO IT IN A TERTIARY CARE HOSPITAL, CHIDAMBARAM

ABOUT AUTHORS
ALEEM SARWAR*1, ADHIN ANTONY XAVIER1, K RAGACHANDANA1, C K DHANAPAL1, S SUDARSHAN2
Department of Pharmacy1, Annamalai University, Chidambaram, Tamil Nadu, India
Department of Medicine2, Rajah Muthiah Medical College, Annamalai University, Chidambaram, India
aleempharma30@gmail.com

ABSTRACT
OBJECTIVE

The aim of our study is to evaluate the door to needle time for ST-segment elevation myocardial infarction and to identify factors associated with a prolonged door to needle time. STEMI most commonly occurs when thrombus formation results in complete occlusion of major epicardial coronary vessels. Percutaneous coronary intervention and Thrombolytics are the two choice of treatment available for STEMI. Where door to needle time have a significant role in determining the efficacy of thrombolytics.

METHODOLOGY
This is a prospective observational study conducted at RMMCH hospital, during the period of Nov 2014 to March 2015, all patient admitted with STEMI, who were thrombolysed were included in the study. Door to needle time is measured and reason for prolongation is identified. Patients who were diagnosed as NSTEMI or unstable angina and who were diagnosed as STEMI and not thrombolysed were excluded from the study.

RESULT
100 patients were included in the study. Which comprises of 72 males and 28 females .door to needle time of < 30 minute was achieved in 27% of study population as per ACC/AHA guidelines were 73% failed to achieve. Highest number of population was observed in the age group of 61-70 which consist of 21 males and 6 females. Mean door to needle time was found to be 44 minutes. Majority of the patients were thrombolysed in between 31 – 45 minutes

CONCLUSION
less than a third of patients with STEMI received thrombolytics within the prescribed time interval of 30 minutes. Delay in decision making and lack of senior medical officers was found to be predisposing factor for the prolongation of door to needle time ,which requires special attention.


EVALUATION OF ANTIBACTERIAL ACTIVITY OF MOMORDICA CHARANTIA

ABOUT AUTHORS
Deepak Ku. Birla*
Shri Bherulal Pharmacy Institute
Indore, Madhya Pradesh, India
deepakbirla7@gmail.com

ABSTRACT
Momordica Charantia is the widely consumed fruit in India. The seeds, fruit, leaves, and root of the plant have been used in traditional medicine for microbial infections, sluggish digestion and intestinal gas, menstrual stimulation, wound healing, inflammation, fever reduction, hypertension and have many significant other medicinal effects. Various phytochemicals present in leaves are extracted using soxhelt apparatus with different solvents. The aim of the study is to assess the antibacterial activity and to determine the zone of inhibition of extracts on some bacterial strains. The antibacterial activity was checked against different human pathogens. The antibacterial activity was determined in the extracts using Disc diffusion method. The present study discusses antibacterial activity of Momordica Charantia extracts. Antibacterial activity was tested against (Pseudomonas aureogenosa, Staphylococcus aureus, Staphylococcus epidermis, Shigella flexineri, Bacillus substilis & E.Coli.). The results showed that the remarkable inhibition of the bacterial growth was shown against the tested organisms.


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.


EFFECTIVE PRECEPTING TO ENHANCE COMMUNICATION SKILLS OF PHARMACY STUDENTS

ABOUT AUTHORS
Srinivasa Babu Puttagunta, Sowjanya Pulipati, Sai Koushik Oruganti
Vignan Pharmacy College, Vadlamudi, Guntur, Andhra Pradesh
kaushikoruganti555@gmail.com

ABSTRACT
Introduction: Clinical pharmacists work directly with doctors, health professionals and patients to ensure that the medications prescribed for patients contribute to the best possible health outcomes. Therefore, pharmacy students should be given opportunities to learn and practice interpersonal communication skills.

Objectives: This observes opinions the position of the pharmacist preceptor in facilitating improvement of conversation capabilities for students participating in community in community advanced pharmacy practice experiences.

Material and methods: Preceptors need to set a stage to comprise precepting into the workflow and to offer green and effective teaching opportunities. College students ought to go through practical activities like affected person counseling  and participating in collaborative work with health care professionals. Preceptors should incorporate the teaching in a lively and demonstrative way for a better impact on their students.
Results and discussion: By following a strategic approach in the methods of teaching the preceptors can effectively and likely enhance the communication skills of the students.

Conclusion: The incorporation of communication skills to pharmacy practice can positively impact the pharmacy site, preceptor, student and more importantly patient.


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