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RIPER PDIC Bulletin, April

2012, Volume 3, Issue 21

R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) , R D T H O S P I T A L ,

B a t h a l a p a l l i , A . P. & R a g h a v e n d r a I n s t i t u t e o f P h a r m a c e u t i c a l

E d u c a t i o n a n d R e s e a r c h ( R I P E R )

2 RIPER PDIC Bulletin, April 2012, Volume 3, Issue 21 [ISSN 2230-8741]

RIPER PDIC Bulletin R I P E R P o i s o n & D r u g I n f o r m a t i o n C e n t e r ( P D I C ) ,

R D T H O S P I T A L , B a t h a l a p a l l i , A . P . &

Raghavendra Institute of Pharmaceutical Education and Research

((((RIPERIPERIPERIPERRRR))))

VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21VOLUME 3, ISSUE 21

APRILAPRILAPRILAPRIL 2012201220122012

Editorial team Page 03

Contents Page 05

Editorial Page 06

Articles Page 07

Drug news 1

Instruction to authors Page 23

‘RIPER’ is the premier educational institution promoted by Raghavendra Educational & Rural

Development Society. The institution is established in 2002 under the leadership of four pharmacy

graduates including Dr. Y. Padmanabha Reddy and Dr. J. Ravindra Reddy. Now the institution

is offering; M. Pharm, B. Pharm, D. Pharm, Pharm D and PharmD (PB) courses approved by AICTE, PCI

and Govt. of AP. The college is affiliated to JNT University, Anantapur (JNTUA) / SBTET, AP.


EDITORIAL BOARDEDITORIAL BOARDEDITORIAL BOARDEDITORIAL BOARD CHIEF EDITORCHIEF EDITORCHIEF EDITORCHIEF EDITOR

Dr. Y. Padmanabha Reddy, Principal, RIPER

EDITOREDITOREDITOREDITOR

Mr. Dixon Thomas, Head, Dept. of Pharmacy Practice, RIPER ASSOCIATE EDITORSASSOCIATE EDITORSASSOCIATE EDITORSASSOCIATE EDITORS

Dr. Adepu Ramesh, Professor, JSS University, Mysore Dr. Gerardo Alvarez-Uria, Head, Dept. of Infectious Diseases, RDT Hospital Dr. C. Sowmya, Professor, RIPER Dr. P. Ramalingam, Professor, RIPER Dr. Jyothi MV, Professor, RIPER Mrs. Seeba Zachariah, Assoc Professor, RIPER Dr. S. Sriram, Professor, SRIPMS, Coimbatore Dr. Roger Walker, Chief Pharmaceutical Officer, Wales, U.K. Dr. Chris Wisniewski, MUSC Drug Information Center, USA Ms. Atefa Noorain, Associate Research analyst, Thomson Reuters, Hyderabad EDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARDEDITORIAL ADVISORY BOARD

Dr. M.S. Kannan, Medical Director, RDT Hospital Dr. A.N. Nagappa, Professor, Manipal University, Karnataka Dr. G.P. Mohanta, Professor, Annamalai Univeristy, T.N. Dr. Gayathri Palat, Program Director, Palliative Access (PAX) Programme, India Dr. C. Vijaya Raghavan, Vice-Principal, PSG College of Pharmacy, T.N. Dr. Subhash C. Mandal, Vice President, IPA-Bengal Branch Dr. Sunil K Jain, Chief Pharmacist, AIIMS, New Delhi Dr. B. J. Mahendra Kumar, Prof, JDT, Kerala Dr. Gunasakaran, Clinical Head, Azidus Laboratory Ltd, T.N. Dr. S.S. Rao, Pharmacist, Canada Mr. Ali Dulfikkar, Pharmacist, Dubai Prof. M.N. Femi Oyewo, Olabisi Onabanjo University, Nigeria Dr. Ugochi Nyere Ogudu, Lagos Island Maternity Hospital, Nigeria Dr. Azubike Okwor, President, Pharmaceutical Association of Nigeria Dr. Cheikh Saad, Univeristy of Thies, Senegal Dr. Stein Lyftingsmo, Pharmacist, Norway Dr. M.K. Unnikrishnan, Professor, Manipal University, Karnataka Mr. Sonal Sekhar, Sr. Lecturer, Manipal University, Karnataka Dr. Hari Hara Nadha Sarma, Medical Superintendent, RDT Hospital, Bathalapalli Dr. H. Harish, Head, Dept. of Anesthesia RDT Hospital, Bathalapalli Dr. Tadepalli Durgesh, Head, Children’s Hospital, RDT Hospital, Bathalapalli Dr. K. Sudheer Kumar, Head, Dept. of Surgery, RDT Hospital, Bathalapalli Dr. Alexander Daniel Sunad, Surgeon, RDT Hospital Mr. K. Thejomoorthy, Chief Pharmacist, RDT Hospital Mr. Prasanth Kumar, Data Manager, Novartis Healthcare Pvt. Ltd. Mr. Tapan Kumar Shah, Clinical Operations, Boehringer Ingelheim India Pvt. Ltd Mr. Tarun Wadhwa, Asst Professor, KLE College of Pharmacy, Belgaum


PUBLICATION COMMITTEEPUBLICATION COMMITTEEPUBLICATION COMMITTEEPUBLICATION COMMITTEE

CHAIRMANCHAIRMANCHAIRMANCHAIRMAN

Dr. J. Ravindra Reddy, Correspondent, RIPER

MANAGING EDITORSMANAGING EDITORSMANAGING EDITORSMANAGING EDITORS

Mr. Vigneshwaran, Asst Professor, RIPER Mr. G. Narayana, Asst Professor, RIPER Dr. Mohan Raj, Asst Professor, RIPER

REGULATORY NEWSREGULATORY NEWSREGULATORY NEWSREGULATORY NEWS

Rohit Bhavsar

D. Giri Rajasekhar

PROOF READINGPROOF READINGPROOF READINGPROOF READING

K. Balaji, Asst Professor, RIPER

S.K.R. Sowmya

N. Sreelalitha

A. Srinadh

INDEXIINDEXIINDEXIINDEXING & DISTRIBUTIONNG & DISTRIBUTIONNG & DISTRIBUTIONNG & DISTRIBUTION

Mr. M. Jaffar, Asst Professor, RIPER Seetharam C Vinay Pawar

K H Ushadevi

V. N. HariKiran

WEBSITE ADMINISTRATIONWEBSITE ADMINISTRATIONWEBSITE ADMINISTRATIONWEBSITE ADMINISTRATION

D. K. Sudheer Naik

RIPER PDIC Bulletin

Raghavendra Institute of Pharmaceutical Education and Research (RIPER)

Chiyyedu Post, Anantapur 515721, AP, India

Phone: 91-8978541693

[email protected], www.riper.ac.in, www.riperjournals.org

Notice: For healthcare professionals only. View of authors are independent to that of

editorial team, it is highly advised for consulting other drug information sources also for

your specific needs. Publisher, editorial team or authors are not responsible for any damage

happens due to the information provided. RIPER PDIC Bulletin Published by the Principal,

RIPER, Anantapur— 515721, A.P


RIPER PDIC Bulletin

CONTENTSCONTENTSCONTENTSCONTENTS

1 Editorial Page 06

2 Medication Therapy Management-how pharmacy

practice is evolving - Paul J. Oesterman

Page 07

3 Good Pharmacy Practice as a tool for transformation

of pharmacies to healthcare facilities - Raj Vaidya,

Seeba Zachariah & BJ Mahendra Kumar

Page 10

4 Inhalation chemotherapy - Bhupinder Singh Sekhon Page 13

5 Drug news Page 21

6 Instruction to the authors Page 23


Editorial

Clinical training – student exchange programs

From the guest editorial of Paul in this issue of the bulletin, it is clear that

there is at least 3 phases of clinical training for Pharmacy students,

Introductory, advanced and residency. In advanced training it is essential that

the Pharm.D students need to undergo training in different health care

setting. As per the current guidelines of Pharm.D education, students have to

complete all the formal training in same institution except an allowed 5 % transfer. There

are high amount of attention and need is arising to have training in different healthcare

settings while the students are in advanced phase of their clinical training (especially in

clerkship and internship). The major variation in clinical practice happens with the basic

policy of the hospital, i.e., either charity or for profit. Also there are variations between

teaching & non-teaching hospitals, urban and rural hospitals, public, trust and private

hospitals and depending on specialty or super-specialty hospitals. Student exchange

programs are one of the key aspects of pharmacy practice education to orient students

towards different clinical settings. I appreciate all organizations who believe that the

student exchange could make a difference in clinical pharmacy or Pharm.D education.

Sincerely yours,

Dr. Y. Padmanabha Reddy, M.Pharm, PhD, FIC

Principal, RIPER & Chief Editor, RIPER PDIC Bulletin

[email protected]

Poison and drug Information services

With the advent of newer electronic devises, poison or drug information

services are available with the practitioner while they practice. But of course

those services will not answer all clinical questions or it may take long time to

get what is required by using those devises. Here the question is that the

practitioner should spend their time to find the answer or contact a poison or

drug information specialist to find the possible answer and dedicate their time

to clinical practice. If complete confidentiality is maintained by the poison or

drug information specialist, I believe there is scope for the service of a poison or drug

information specialist in all hospitals.

I invite the poison or drug information specialists to give a short note on the potential

services they provide and how it is helpful to the healthcare. We could include those

experiences in the upcoming issues of the bulletin to strengthen the services of poison or

drug information specialists.

Best Regards,

Mr. Dixon Thomas, M.Pharm, M.S., M.Sc.

HOD, Pharmacy Practice, RIPER & Editor, RIPER PDIC Bulletin

[email protected]


Medication Therapy Management - how pharmacy practice is evolving

Paul J. Oesterman

Associate Professor Pharmacy Practice, Roseman University of Health Sciences, Nevada, USA

Introduction

Questions about next steps were raised

following the Inaugural Quality Pharmacy

Practice Module- Advanced Learning

Series. While the practice of pharmacy in

the United States is considerably different

from how it is currently being practiced in

India, there is a mobilization to increase

the clinical knowledge and expand the

scope of pharmacy practice through

Medication Therapy Management (MTM)

in India. This evolution is one that

requires careful thought and planning to

assure the successful implementation of

the clinical model.

Educational Paradigm Shift

While much of the required disease state

education and training will take place in

the academic institutions, there are three

critical initial components that need to be

concurrently incorporated to allow for

successful implementation of clinical

pharmacy and MTM. The first critical

component is associated with the law and

recognition of the roles that clinically

trained pharmacists play, the second

relates to the role of technology, and the

third significant piece is the clinical

training.

Legal Perspective

It is imperative that the laws governing

the practice of pharmacy be relevant to

how pharmacy is being currently practiced

and that compliance is carefully

monitored by the respective regulatory

agencies. Collaborative efforts through

the Indian Association of Colleges of

Pharmacy (IACP) can assist with

development of practice guidelines.

Careful designation of the duties that can

be performed by technicians versus those

that can be performed by clinically trained

pharmacists must be clearly delineated

and strictly enforced.

Technological Perspective

The current technology available to

pharmacists needs to be maximized.

A

good starting point for the community

pharmacy practitioner will be the creation

of patient profiles. These profiles can be

either paper format or stored

electronically, with the latter being

preferred. The profile should include

select patient demographics including

name, address, phone, and date of

birth/age, height and weight, known drug

allergies, medical providers, list of current

medical conditions and current

medications (prescription and non-

prescription). In addition to the patient

demographics, the profile can be used to

assist with assurance of patient adherence

to their medical regimens.

Clinical Perspective

The clinical training is going to require

that pharmacy students spend time in

experiential sites where they are able to


place their didactic teachings into the real

world of healthcare. Most students in the

United States spend a minimum of 2000

hours divided between introductory

Pharmacy Practice Experiences (IPPEs)

and Advanced Pharmacy Practice

Experiences (APPEs). The IPPEs can be

completed in a variety of pharmacy

settings including both community and

institutional pharmacies and are generally

started early in the educational program.

The goal of the IPPE is to permit the

student pharmacist to actively see, learn,

and practice the technical components of

prescription dispensing under the

guidance of a mentor preceptor

pharmacist.

Student pharmacists are

assessed by their preceptors. While

students are at their experiential sites,

they incorporate their didactic training

and contribute to the health of the

patients and the knowledge of their

preceptors. The APPEs generally consist

of a series of 6 to 8 week rotations at

various practice sites where the students

spend more time applying their didactic

knowledge as it relates to disease state

management and “Clinical Pharmacy”.

Students complete 4 required rotations

including: Adult Acute Care, Advanced

Community, and Ambulatory Care &

Health System Pharmacy. They may also

complete additional rotations in direct

patient care areas such as pediatrics,

oncology, and diabetes. Following

graduation with their Pharm.D degree,

many students continue their education in

a focused area completing a Pharmacy

Residency where they specialize in a

focused area of pharmacy practice. Other

pharmacists will obtain accreditation or

certification in specialty programs like

immunizations, diabetes, hypertension,

lipid management.

Conclusions

While the Inaugural program was

designed to give a brief overview of MTM

and select disease states, there are many

tools available and the steps to successful

implementation must be carefully

navigated to avoid some of the pitfalls

that others have experienced.

References/Resources:

1. American Pharmacists Association.

Integrating Medication Therapy

Management (MTM) Into the

Curricula of Schools and Colleges

of Pharmacy. March 2012, pg 1-8.

2. McMahan R. Operationalizing

MTM through the use of health

information technology. J Manag

Care Pharm. 2008, 14(2)(suppl S-

a):S18-21.

3. Posey LM. Early experiences link

students, MTM, patients.

Pharmacy Today. 2009, 15(1):48.

4. Farnstrom B. MTM mentor and

practitioner. Pharmacy Today.

2009, 15(12):29-31.

5. Spooner JJ. Medication therapy

management programs: When will

the outcomes come out? J Manag

Care Pharm. 2007, 13:276-7.

6. Culhane N, Brooks A, Cohen V,

Couchenour R, Ferreri S, et al.

Medication therapy management

services: Application of the core

elements in ambulatory settings.

ACCP Board of Regents. January

23, 2007.


7. Barnett MJ, Frank J, Wehring H,

Newland B, VonMuenster S, et al.

Analysis of pharmacist-provided

medication therapy management

(MTM) services in community

pharmacies over 7 years. J Manag

Care Pharm. 2009, 15(1):18-31.

8. Cahill JA, Manasse HR. Medication

therapy management programs:

To optimize pharmacy outcomes. J

Manag Care Pharm. 2005, 11:179-

86.

9. MacIntosh C, Weiser C, Wassimi A,

Reddick J, Scovis N, et al. Attitudes

toward and factors affecting

implementation of medication

therapy management services by

community pharmacists. J Am

Pharm Assoc. 2009, 49:26-30.

10. McDonough R. Focusing on the

nitty-gritty of MTM. Pharmacy

Today. 2009, 15(1):49.

11. Patel J. Bringing student

pharmacists into the patient care

process. Pharmacy Today. 2008,

14(6):32.


Good Pharmacy Practice as a tool for transformation of pharmacies to

healthcare facilities

Raj Vaidya1, Seeba Zachariah

2 & BJ Mahendra Kumar

3

1Immediate - Past Vice-President, Indian Pharmaceutical Association &/or Community

Pharmacist, Hindu Pharmacy, Panaji 2Assoc Prof, RIPER, Anantapur, A.P

3Director, PG Studies, JDT Islam College of Pharmacy, Calicut, Kerala

In 2011, the Pharmacy Council of India has

mandated that all pharmacy practice

departments in teaching hospitals to

implement and adhere to Good pharmacy

practice (GPP), and that curriculum of

D.Pharm, B.Pharm and Pharm.D should

include aspects and components of GPP.

GPP has been a standard for guiding the

pharmacies around the globe for

achieving their quality in operation. Many

countries make their national GPP with a

regulatory vision to reciprocate standard

practices of pharmacy in the country. For

the hospitals or the proprietors it could be

used as a management tool and for the

pharmacists, GPP works with a moral

vision. Other so called ‘good’ practice

guidelines are Good Manufacturing

Practice (GMP), Good Laboratory Practice

(GLP) and Good Clinical Practice (GCP).

There are also some other GPPs in use;

such as Good Pharmacovigilance Practice,

Good Pharmaco-epidemiological Practice

and Good Publishing Practice.

The International Pharmaceutical

Federation (FIP) first released GPP

Guidelines in 1992, and this was then

endorsed by the WHO in 1997. In 2002,

the Indian Pharmaceutical Association

prepared GPP Guidelines for Community

Pharmacy in India, and followed it up in

2005, by preparing a GPP Training Manual

for community in collaboration with the

Central Drugs Standard Control

Organization and World Health

Organization (WHO) India Country Office.

The GPP Training Manual has 6 Modules,

and a set of SOPs.

Module I: Regulatory Affairs

Module II: Procurement and Inventory

Management

Module III: Storage and Stock

Management

Module IV: Dispensing

Module V: Patient Information

Module VI: Rational Use of Medicines.

These modules were prepared based on

the GPP Guidelines, the drug laws in the

country, and took into consideration the

ground realities and situation in

community pharmacy in India. The

Modules have been prepared in an easy

to understand language with simple

illustrations, charts, and examples, to

guide community pharmacies across the

country, in every nook and corner, to


adapt GPP and upgrade their pharmacies

and practice.

The module “Regulatory Affairs” is largely

dealing with the compliance of regulatory

requirements to operate pharmacies in

India. There is lots of room for regulatory

reform in India to make the Indian

pharmacies to work for health screening

and pharmaceutical care. The leading

pharmaceutical associations in the

country such as Indian Pharmaceutical

Association (IPA) have to work with

regulatory bodies to improve the legal

priorities to expand the healthcare

practices of pharmacists in the country. As

in some of the developed countries, if the

pharmacist is licensed to administer

selected immunization or do some lab

tests and other health screening

techniques like measuring the lean body

mass, etc., the pharmacies will have a

facelift to a healthcare facility in the

society. The regulation should allow

limited but essential patient management

rights to the pharmacies especially when

considering rural India with access to

medical care, and where a pharmacy

could cater the basic health care needs

and referral services to the rural public.

The Module II and III are largely

concerning with choosing, managing,

handling and storage of the product in

pharmacies.

The Module on “Dispensing”, the core

activity of a pharmacy deals with the

various aspects of every step of

dispensing, right from receiving the client

and the prescription to handing over the

medicines, in a very lucid, systematic

manner, with ample illustrations. The

Module on “Patient Information” deals

with various means of providing

information to the patient, both written

and verbal (through patient instructions

and counseling) and how pharmacies

should go about it, to increase their

professional outlook as well as increase

compliance amongst the patients, a very

important component of providing

pharmaceutical care. The last Module is a

policy aspect to take the responsibility

that the medicines are used rationally at

the prescriber, pharmacist, nurse and

patient levels. Rational use not only

benefits the patient but also has national

priority when it comes to prevention and

management of drug resistance, misuse of

medicines, reducing adverse reactions,

and effective management of medical

resource and economy.

With the evolution of a more patient

focused approach by the pharmacies, the

Patient Information Modules needs to be

further expanded to include finer aspects

of pharmaceutical care, an important

organ of pharmacy. In pharmaceutical

care or medical therapy management (as

it is called in USA) or medication action

plan (as it is called in Australia) the sub

areas to be established well in pharmacies

are;

• Health Screening Services and

Immunization

• Drug Interaction Screening and

Management

• Adverse drug reaction monitoring

• Medication error prevention and

management


• Health Information Services and

referral services

• Pharmacoeconomic Services

It is understood that because of patient

load, during the dispensing process it is

not possible to provide pharmaceutical

care services. Besides, dispensing is a full

time, full attention responsibility.

Therefore, there should be and additional

pharmacist in the pharmacy, who could

provide the other healthcare services and

charge for the consultation. There should

be legal permission for collecting this

charge and the insurance companies

should agree to pay for the pharmacy

consultation. In many developed counties,

pharmacies are legally permitted to

provide certain healthcare services and

charge for it. Most of the insurance

companies including the government

health insurance recognize the

importance of pharmacy consultation and

how it reduces the number of

hospitalizations and other healthcare

costs.

So, we hope the usefulness of GPP as a

tool for making pharmacies into

healthcare facilities is fairly explained. If

you have a point to add, please feel free

to contact: Raj [email protected]

Further reading:

WHO India, GPP – training manuel,

http://whoindia.org/en/Section2/Section

5/Section403.htm


Inhalation chemotherapy

Bhupinder Singh Sekhon

PCTE Institute of Pharmacy, near Baddowal Cantt, Ludhiana-142 021, India.

e-mail:[email protected]

Abstract

Certain medicinal agents are more effectively delivered to the body by vaporizing them and

inhaling them. Inhalation therapies are considered safe and effective methods for treating

lung disease as well as a variety of other health conditions. Inhalation chemotherapy focus

on targeting chemotherapy that it goes selectively to the lungs and has much lower

concentrations in the blood stream (minimizes side effects).

Keywords: Inhalation, lung cancer, insulin, glutathione, asthma.

Introduction

Advances in drug formulation and

inhalation device design are creating new

opportunities for inhaled drug delivery.

Inhaled medicines are the first choice and

are an important part of controlling and

treating asthma and chronic obstructive

pulmonary disease. These medicines

begin to work within few minutes and

have fewer side effects. Moreover, the

medicine goes right to the lungs and does

not easily go into the rest of the body.

There are a number of devices that deliver

medicine directly to the airways.

Metered-dose inhalers, dry powder

inhalers and nebulizers are currently

available with different medicines.

Inhalational chemotherapy was first

reported in 1968.1 Inhaled steroids, also

known as inhaled corticosteroids have

become the mainstay of asthma

treatment for persistent asthma in

children and adults. The use of inhaled

steroids leads to: better asthma control,

fewer symptoms and flare-ups and

reduced need for hospitalization.2 Many

brands of inhaled corticosteroids are

available such as: Fluticasone (Flovent),

Budesonide (Pulmicort), Triamcinolone

(Azmacort), Flunisolide (Aerobid),

Beclomethasone (Qvar).3 Almost all COPD

medications are inhaled including inhaled

corticosteroids. Inhalation marijuana is an

effective therapy for the treatment of

nausea and vomiting due to cancer

chemotherapy.4

Inhalant chemotherapy using paclitaxel or

doxorubicin has been investigated in dogs

with primary and metastatic lung tumors.5

Inhaled fluticasone propionate decreased

the incidence of delayed pulmonary

toxicity syndrome and decline in

pulmonary function in breast cancer

patients undergoing high-dose

chemotherapy with the conditioning

regimen of cyclophosphamide, cisplatin,

and carmustine followed by autologous

stem cell transplantation.6 Air hunger, or

dyspnea, is a frequent and devastating

symptom in patients with advanced

cancer. Nebulized morphine has the

potential to act more quickly, is relatively

easy to administer, and could sidestep the

sedating side effects that occur with

injections.7


Inhalation of nebulized furosemide seems

to be an effective and useful treatment

for dyspnea in terminal cancer patients.

Dyspnea dramatically improved and could

be controlled for weeks. Moreover, no

noticeable side effects were observed.8 A

variety of opioids have been administered

for inhalation dyspnea.9 The rationale of

drug delivery by the inhalational route, its

technical challenges, preclinical and

clinical experiences, limitations, and

promise have been reported.10

Scientists have successfully used pet dog

cancer models to evaluate the delivery of

cytotoxic chemotherapy and cytokines by

aerosol for the treatment of primary

cancers of the lung and cancers

metastatic to the lung.11

Asthma

treatment by inhaled drugs began in

earnest in the 1950s, and now targeted

treatment with inhaled drugs is actively

considered for treating many other lung

diseases. The first such product to be

marketed was Exubera (first inhaled

insulin product).12,13

In October

2007,Pfizer discontinued the production

of Exubera due to poor sales.14

Currently,

major advances have led to increasing

interest in systemic delivery of drugs by

inhalation. In this direction, small

molecules can be delivered with very

rapid action, low metabolism and high

bioavailability; and macromolecules can

be delivered without injections.

Reduced glutathione or simply glutathione

(γ-glutamylcysteinylglycine; GSH) is found

in the cytosol of most cells of the body.

GSH in the epithelial lining fluid of the

lower respiratory tract is thought to be

the first line of defense against oxidative

stress. Inhalation (nebulized or

aerosolized) is the only known method

that increases GSH's levels in the

epithelial lining fluid. The clinical

effectiveness of inhaled glutathione as a

treatment for various pulmonary diseases

and respiratory-related conditions has

been reported. Reasons for inhaled GSH's

effectiveness include its role as a potent

antioxidant, and possibly improved

oxygenation and host defenses. Inhaled

glutathione was found effective for

treating lung diseases, including idiopathic

pulmonary fibrosis, cystic fibrosis, and

lung disease in people with HIV disease.15

One of the primary side effects of existing

methods of drug delivery is kidney

damage. Damage to the kidneys could be

avoided with the administering of drugs

by inhalation. Some companies are

developing inhaled forms of the drug to

reduce the need for daily injections

among diabetics. Aerogen in Galway,

Ireland and Dance Pharmaceuticals in San

Francisco, California have announced a

drug-delivery partnership for the

production of inhaled insulin in January

2011.16

It was announced in September

2011 that a form of inhalable insulin,

aerosolized insulin, applied deep into the

nostrils may delay the onset of

Alzheimer.17

A new delivery technology

developed by the Aradigm Corp.,

Hayward, Calif., has been tested in about

100 patients to deliver aerosolized

morphine directly into the lung for acute

or breakthrough pain.18

Inhalation chemotherapy in lung cancer

Inhalation therapy is being explored as a

way to deliver chemotherapy drugs

directly to the lungs, either for a primary

cancer or cancer that has spread to the

lungs. Osteosarcoma is a rare childhood

bone cancer that can be fatal because it

spreads to the lungs. Lung cancer and

mesothelioma, a cancer of the lining of

the lung, take large number of lives each

year and affects both smokers and non-


smokers, killing more than half of the

people who get it within five years.19

Lung

cancer is histologically separated into

either small-cell lung cancer (SCLC) or

nonsmall-cell lung cancer (NSCLC). NSCLC

is much more common, and can occur in

the periphery (adenocarcinomas) or

central airways (squamous cell

carcinomas). It is argued that inhalation of

chemotherapy as an adjuvant in Stage II

NSCLC and inhalation of chemopreventive

agents in Stage I adenocarcinomas are

direct paths to improve lung cancer

therapy as well as demonstrate the ultility

of inhalation therapy.

Regional chemotherapy has been

proposed as a treatment modality in a

number of cancer settings. In case of

primary or metastatic lung cancer,

administration of chemotherapy via

inhalation could increase exposure of lung

tumour to the drug, while minimizing

systemic side effects. Several studies in

animal models of metastatic or primary

lung cancer have demonstrated the

safety, pharmacokinetic advantage, and

antitumor effect of aerosol administration

of several chemotherapeutic agents

including doxorubicin, gemcitabine and

liposome-encapsulated formulations of

paclitaxel and 9-nitrocamptothecin.

Recent phase I studies have demonstrated

the feasibility of aerosol delivery of

doxorubicin and liposomal formulations of

9-nitrocamptothecin and cisplatin in

patients with primary and metastatic lung

cancer with a limited pharmacokinetic

profile consistent with the observed low

systemic toxicity.20

Researchers hypothesized that a

substantial enhancement in the efficiency

of lung cancer treatment is possible by (i)

local delivery of chemotherapeutic

agent(s) by inhalation and (ii)

simultaneous suppression of at least

major mechanisms of lung cancer cell

resistance. A variety of chemotherapeutic

agents including cisplatin, mitomycin, and

5-fluorouracil administered by inhalation

have been evaluated in preclinical models.

Researchers have tested the

administration of 5-fluorouracil by

inhalation in dogs and found high levels of

the drug in the trachea, hilar bronchi, and

regional nodes. Subsequently, the same

authors treated 10 patients with

inoperable lung tumors with 5-fluorouracil

administered via supersonic nebulizer at a

dose of 250 mg twice daily for 2 to 3 days

per week. There was antitumor efficacy

with two complete and four partial

responses observed.21

In addition to administration of inhaled

chemotherapeutic agents, Huland et al.

administered interleukin-2 (IL-2) by

inhalation with concomitant IFN-α

administered subcutaneous to 15 patients

with metastatic renal carcinoma. There

seemed to be improved response in lung

compared with non-lung metastases,

suggesting that inhalational IL-2 displayed

enhanced antitumor efficacy in pulmonary

lesions.22

Nebulized IL-2 in combination

with systemic IL-2 has also been evaluated

in patients with renal cancer.23

More

recent studies have been done using

formulations of cisplatin, camptothecins,

and alternative biological response agents

with exciting early results.24-27

Researchers have shown the safety of

delivering doxorubicin using a novel

inhalational delivery device.28

The efficacy

of inhaled doxorubicin HCl when given in

combination with intravenous docetaxel

and cisplatin in patients with NSCLC have

been reported.29

Research is currently underway to address

issues of local versus systemic toxicity,

optimal drug delivery and selection of

optimal drugs and schedules including

outpatient aerosol therapy.30

Paediatric


cancer specialists investigated inhalation

chemotherapy with the potential to treat

children with a deadly bone cancer that

has spread to their lungs.31

One of the most widely used cancer-

fighting drugs, cisplatin, was administered

in a vaporized form, enabling medical

professionals to get the drug to the

cancerous cells while avoiding damage to

healthy cells nearby. Damage caused to

healthy cells can be especially debilitating

to patients suffering from mesothelioma.

In other words, delivery of vaporized

cisplatin by means of inhalation would

help mesothelioma patients live longer

and enjoy a higher quality of life.32

Development of cancer cell resistance,

low accumulation of therapeutic drug in

the lungs, and severe adverse treatment

side effects represent main obstacles to

efficient chemotherapy of lung cancer. To

overcome these difficulties, scientists

have reported inhalation local delivery of

anticancer drugs in combination with

suppressors of pump and non-pump

cellular resistance. Nanoscale-based

delivery systems containing doxorubicin

as a cell death inducer, antisense

oligonucleotides targeted to MRP1 mRNA

as a suppressor of pump resistance and to

BCL2 mRNA as a suppressor of non-pump

resistance, were developed and examined

on an orthotopic murine model of human

lung carcinoma. The experimental results

showed high antitumor activity and low

adverse side effects of proposed complex

inhalatory treatment that cannot be

achieved by individual components

applied separately.33

Mesothelioma is a rare and deadly disease

that affects the mesothelium, or the lining

of organs such as the lungs, abdominal

organs, and heart. In the case of pleural

mesothelioma, the disease affects the

pleura, the lining of the lungs. Inhaled

chemotherapy was found useful to pleural

mesothelioma patients because it targets

only the cancerous cells in the lungs, while

injected chemotherapy affects any

healthy cells it comes into contact with.34

Inhaled chemotherapy is still under

examination as an alternative therapeutic

modality for NSCLC treatment regarding

to respiratory function side effects.

Researchers showed that patients in

partial inhaled chemotherapy have a

statistically significant survival benefit

without any side effect in respiratory

function.35

A tumour targeted mesoporous silica

nanoparticles (MSN)-based drug delivery

system (DDS) was developed for

inhalation treatment of lung cancer. The

system was capable of effectively

delivering inside cancer cells; anticancer

drugs (doxorubicin and cisplatin)

combined with two types of siRNA

targeted to MRP1 and BCL2 mRNA for

suppression of pump and non-pump

cellular resistance in non-small cell lung

carcinoma, respectively. Researchers

achieved targeting of MSN to cancer cells

by the conjugation of LHRH peptide on

the surface of MSN via (polyethylene

glycol) spacer. The delivered anticancer

drugs and siRNA preserved their specific

activity leading to the cell death induction

and inhibition of targeted mRNA.

Suppression of cellular resistance by

siRNA effectively delivered inside cancer

cells and substantially enhanced the

cytotoxicity of anticancer drugs. Local

delivery of MSN by inhalation led to the

preferential accumulation of

nanoparticles in the mouse lungs,

prevented the escape of MSN into the

systemic circulation, and limited their

accumulation in other organs. The

experimental data confirmed that the

developed DDS satisfies the major


prerequisites for effective treatment of

non-small cell lung carcinoma. In view of

above, the proposed cancer-targeted

MSN-based system for complex delivery

of drugs and siRNA has high potential in

the effective treatment of lung cancer.36

The safety and efficacy of inhaled

antineoplastic drugs, using pet dogs with

spontaneously arising primary and

metastatic lung cancers (including

sarcoma, carcinoma, and malignant

melanoma) as a model was reported.

Dogs received new formulations of either

paclitaxel or doxorubicin by the inhalation

route every 2 weeks using a specially

designed aerosol device avoided systemic

toxicity while delivering efficacious local

drug levels by the inhalation route.37

Regional chemotherapy to the lung

parenchyma for lung cancer was found

feasible and efficient. However, safety

depends on the chemotherapy agent

delivered to the lungs and is dose-

dependent and time-dependent.38,39

Clinical trials are on track to develop

pulmonary marinol that would be

delivered with a pressurized metered

dose inhaler .This method has shown

immediate and rapid systemic absorption,

however FDA approval is still awaited. In

the meantime, Sativex, an oral cannabis

spray consisting of natural cannabinoid

extracts has already been approved for

use in Canada, New Zealand and eight

other European countries, and hopes to

gain FDA approval for use by US patients

by 2013. Just as inhaling cigarette smoke

can cause lung cancer, inhaling

medication may treat it. National

Institutes of Health and the National

Cancer Institute funded the research

project that involves inhaling a drug called

5-azacytidine to target the bronchial

epithelium. 5-azacytidine is a

demethylating agent, meaning it strips off

methyl groups that have bound to genes

and rendered them inactive. Since

removing methyl groups can reactivate

genes that suppress tumors, drugs such as

5-azacytidine can potentially treat a

number of different types of cancers.

Chemotherapy plays a significant role

both as primary and as supportive care for

lung cancer treatment. The majority of

currently available anticancer agents are

administrated intravenously, causing side

effects due to the systemic drug

distribution. Alternatively, the

bioavailability of orally administrated

anticancer agents is usually compromised

by the first-pass metabolism. Pulmonary

administration may be a potential route

for anticancer drug delivery to treat lung

tumors, due to its site specific delivery,

avoidance of first-pass metabolism,

possibility of fewer side effects, and

improved comfort for cancer patients

using a needle-free delivery device.

However, to attain an effective

inhalational delivery, there is a

requirement to design a formulation with

appropriate aerodynamic properties with

well-suited excipients. This review article

explores work to date related to the

formulations developed for pulmonary

delivery of small molecule antineoplastic

agents to treat primary and metastatic

lung carcinomas. Ultimately, it highlights

the importance of formulation design to

define the role of inhalational

chemotherapy.40

More research is

required regarding inhaled chemotherapy

delivery method. Experts are of the

opinion that inhaled chemotherapy could

one day be administered at home with

fewer systemic adverse effects. It is also

hoped that inhaled chemotherapy

discovery will lead to other less invasive

drug delivery systems for other types of

mesothelioma and asbestos diseases.


Conclusions

The concept of delivering drugs by

inhalation for the treatment of cancers in

the lung is attractive. Researchers have

showed that much higher local drug

exposure can be achieved with total doses

considerably lower than those required

for systemic administration, resulting in

lower exposure of non-respiratory tract

tissues to potentially toxic drugs.

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4. Vinciguerra V, Moore T, Brennan E,

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5. Elizabeth Hershey A, Kurzman ID,

Forrest LJ, Bohling CA, Stonerook M,

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8. Shimoyama N, Shimoyama M.

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treatment for dyspnea in terminal

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Symptom Management 2002; 23(1):

73-76.

9. Ferrarest V. Inhaled opioids for the

treatment of dyspnea. Am J Health-

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10. Sharma S, White D, Imondi AR, Placke

ME, Vail DM, Kris MG. Development

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11. Khanna C, Vail DM. Targeting the

Lung: Preclinical and comparative

evaluation of anticancer aerosols in

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medicines: delivering drugs to the

body through the lungs. Nat Rev Drug

Discov, 2007; 6, 67-74.

13. McMahon GT, Arky RA. Inhaled insulin

for diabetes mellitus. N Engl J Med

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Urban T, Le Pape A, Valo I, Montharu

J, Leblond V, Boisdron-Celle M,

Lerondel S, Majoral C, Diot P,

Racineux JL, Lemarie E. Aerosolized

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27. Verschraegen CF,Gilbert BE, Loyer E,

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29. Otterson GA, Villalona-Calero MA,

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Bohling CA, Stonerook M, Placke ME,

Imondi AR, Vail DM. Inhalation

chemotherapy for macroscopic

primary or metastatic lung tumors:

proof of principle using dogs with

spontaneously occurring tumors as a

model. Clin Cancer Res. 1999; 5(9):

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80.


Drug news

Collected by Giri Rajasekhar

Aliskiren combinations in diabetes and

renal impairment

Aliskiren is a renin inhibitor used to treat

high blood pressure (hypertension) by

lowering blood pressure.

FDA notified healthcare professionals of

possible risks when using blood pressure

medicines containing aliskiren with other

drugs called angiotensin converting

enzyme inhibitors (ACEIs) and angiotensin

receptor blockers (ARBs) in patients with

diabetes or kidney (renal) impairment.

These drug combinations should not be

used (are contraindicated) in patients with

diabetes. In addition, avoid use of

aliskiren with ARBs or ACEIs in patients

with moderate to severe renal

impairment (i.e., where glomerular

filtration rate [GFR] < 60 mL/min).

Stopping aliskiren suddenly is not advised

without taking other measures to control

blood pressure.

Reference:

http://www.fda.gov/Safety/MedWatch/S

afetyInformation/SafetyAlertsforHumanM

edicalProducts/ucm301120.htm

Use of statins and HIV Drugs could

increases Risk of Muscle Injury

Statins are a class of prescription drugs

used together with diet and exercise to

reduce blood levels of low-density

lipoprotein (LDL) cholesterol (“bad

cholesterol”). HIV protease inhibitors are

a class of prescription anti-viral drugs used

to treat HIV.

FDA notified healthcare professionals of

updates to the prescribing information

concerning interactions between protease

inhibitors and certain statin drugs.

Protease inhibitors and statins taken

together may raise the blood levels of

statins and increase the risk for muscle

injury (myopathy). The most serious form

of myopathy, called rhabdomyolysis, can

damage the kidneys and lead to kidney

failure, which can be fatal.

Reference:

http://www.fda.gov/Safety/MedWatch/S

afetyInformation/SafetyAlertsforHumanM

edicalProducts/ucm294294.htm

Measles outbreak in 2011 highest in last

15 years in USA

There were 222 cases and 17 outbreaks of

the measles in the United States in 2011it

was the highest in last 15 years," said Dr.

Anne Schuchat, director of the National

Center for Immunization and Respiratory

Disease at the U.S. Centers for Disease

Control and Prevention.

In the prior decade, an average of 60

cases and four outbreaks were reported

annually.

The highly infectious illness seems to be

making an unexpected comeback.

Measles was declared eliminated in 2000

after public health measures successfully

interrupted the transmission of disease

from person-to-person in the United

States. The disease is still endemic in

many other parts of the world, however.

And most of the outbreaks resulted from

foreign travel.

Reference: Medlineplus:

http://www.nlm.nih.gov/medlineplus/ne

ws/fullstory_124281.html


Summer temperature fluctuations risk

old people with chronic diseases

People generally adapt to the

temperatures where they live. But drastic

fluctuations in temperature are known to

increase chances of health risks. Those

who are very old, very young, overweight

or infirm are especially vulnerable. There

are also seasonal variations in some sort

of infections also.

Dr. Antonella Zanobetti of the Harvard

School of Public Health led a research

team to study the long-term impact of

summer temperature variability in 135

U.S. cities. The scientists analyzed

Medicare data on more than 3.7 million

at-risk people, ages 65 and older. The

study populations were released after

hospitalization for chronic obstructive

pulmonary disease (COPD), congestive

heart failure, diabetes or a heart attack.

Some patients were followed up even up

to 21 years. The results shows that

greater the summer temperature

variation, greater was the risk on life.

Reference: NIH Research Matters:

http://www.nih.gov/researchmatters/apri

l2012/04162012summer.htm


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