trends in drug delivery vol 3 issue 3
TRANSCRIPT
Trends in
Drug Delivery(TDD)
September–December 2016
ISSN 2394-7268 (Online)
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Trends in Drug Delivery
ISSN: 2394-7268(online)
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It is my privilege to present the print version of the [Volume 3 Issue 3] of our Trends in Drug Delivery,
2016. The intension of TDD is to create an atmosphere that stimulates vision, research and growth in
the area of Drug Delivery.
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STM JOURNALS
1. Sublingual Drug Delivery System: An Update Vivek P. Chavda, Moinuddin Soniwala 1
2. Drug Profile: Mebeverine Hydrochloride S. Shanmugam, T. Ayyappan, T. Vetrichelvan 20
3. Quality by Design (QbD) Approach for Optimization and Development of Nano Drug Delivery Systems Daisy Arora, Bharat Khurana, R.K. Narang, Sanju Nanda 23
4. A Case Study: Efficacy of Panchakarma in a Case of Lipidema with Fibromyalgia Ish Sharma, Aparna Sharma, Nancy Shahi 33
5. Curcumin: A Review on Methods for Enhancing Its Bioavailability Ruchika Goyal, Sandeep Jain, Ashwani Kumar 37
ContentsTrends in Drug Delivery
TDD (2016) 1-19 © STM Journals 2016. All Rights Reserved Page 1
Trends in Drug Delivery ISSN: 2394-7268(online)
Volume 3, Issue 3
www.stmjournals.com
Sublingual Drug Delivery System: An Update
Vivek P. Chavda*, Moinuddin Soniwala
Department of Pharmaceutics, B. K. Mody Government Pharmacy College, Near Ajidem, Rajkot-
Bhavnagar Highway, Gujarat Technological University, Rajkot, Gujarat, India
Abstract Oral transmucosal delivery, especially sublingual delivery, has progressed far beyond the use
of traditional dosage forms with novel approaches emerging continuously. Drug delivery via
the oral mucous membrane is considered to be a promising alternative to the oral route,
offering a vast number of advantages. Sublingual delivery tends to administer substance via
mouth in such a way that the substance is rapidly absorbed via blood vessels under tongue,
bypassing the hepatic first‐ pass metabolism and providing acceptable bioavailability with
better patient compliance. New sublingual technologies address many pharmaceutical and
patient needs, ranging from enhanced life‐ cycle management to convenient dosing for
pediatric, geriatric, and psychiatric patients. This review discusses the physiology of the oral
cavity in vivo relating to the performance of transmucosal delivery systems, the physiological
challenges as well as the opportunities for sublingual drug delivery. This review also
highlights the various sublingual dosage forms, factors affecting the sublingual absorption,
advantages, different evaluation parameters and commercially available sublingual dosage
forms.
Keywords: Transmucosal delivery, sublingual, acceptable bioavailability
INTRODUCTION The oral route remains the preferred route for
the administration of therapeutic agents due to
low cost, ease of administration and high level
of patient compliance. However, significant
barriers such as hepatic first pass metabolism
and drug degradation within the
gastrointestinal (GI) tract prohibiting the oral
administration of certain classes of drugs
especially biologics e.g. peptides and proteins.
However, other absorptive mucosae are being
considered as potential sites for drug
administration including the mucosal linings
of the nasal, rectal, vaginal, ocular, and oral
cavity, offering specific advantages over per
oral administration for systemic drug delivery
such as the possible bypass of the first pass
effect and avoidance of presystemic
elimination within the GI tract [1].
Amongst these, delivery of drugs to the oral
cavity has attracted particular attention due to
high patient compliance and unique
physiological features. Within the oral
mucosal cavity, the delivery of drugs is
classified into two categories: (i) local delivery
and (ii) systemic delivery, either via the buccal
or sublingual mucosa. This review examines
the various physiological considerations of the
oral cavity for potential of systemic drug
delivery and provides an insight into the
advances in sublingual delivery systems [2].
OVERVIEW OF TRANSMUCOSAL
DRUG DELIVERY Structure of Oral Mucosa The anatomical and physiological properties of
the oral mucosa have been reviewed in depth
by several authors [1–3]. The oral cavity
comprises the lips, cheeks, tongue, hard palate,
soft palate and floor of the mouth (Figure 1).
The lining of the oral cavity is referred to as
the oral mucosa, and it includes the buccal,
sublingual, gingival, palatal and labial mucosa.
The buccal, sublingual and the mucosal
tissues, present at the ventral surface of the
tongue, account for about 60% of the oral
mucosal surface area.
The top quarter to one-third of the oral mucosa
is made up of closely compacted epithelial
cells (Figure 2). The primary function of the
oral epithelium is to protect the underlying
tissue against potential harmful agents in the
TDD (2016) 20-22 © STM Journals 2016. All Rights Reserved Page 20
Trends in Drug Delivery ISSN: 2394-7268(online)
Volume 3, Issue 3
www.stmjournals.com
Drug Profile: Mebeverine Hydrochloride
S. Shanmugam*, T. Ayyappan, T. Vetrichelvan Department of Pharmaceutics, Adhiparasakthi College of Pharmacy, Melmaruvathur, Tamil Nadu,
India
Abstract Irritable bowel syndrome (IBS) is the most prevalent functional gastrointestinal disorder
noted in the general population worldwide. Its chronic nature, signs and symptoms which vary
periodically from mild to severe have many negative effects on the quality of life for the
sufferer; therefore, the appropriate treatment of these patients is highly important. Patients
should be informed by their doctors that the nature of the disease is benign, and educated on
how to deal with and control symptoms of the disease. Mebeverine is used to treat a number of
problems. It is a direct relaxant of gut (intestinal) muscle, and is sometimes known as an
antispasmodic drug. It is used to relax the muscles of the intestine and to treat symptoms of
irritable bowel syndrome and related conditions.
Keywords: Gastrointestinal disorder, Mebeverine, Antispasmodic drug, Bowel syndrome
INTRODUCTION Mebeverine is a drug whose major therapeutic
role is in the treatment of irritable bowel
syndrome (IBS) and the associated abdominal
cramping. It works by relaxing the muscles in
and around the gut. It is a musculotropic
antispasmodic drug without anticholinergic
side-effects. The drug is also indicated for
treatment of gastrointestinal spasm secondary
to organic disorder [1].
Chemical Name
Mebeverine is also known as 4-[ethyl-[1-(4-
methoxyphenyl)propan-2-yl]amino]butyl 3,4-
dimethoxybenzoate;hydrochloride [2].
Chemical Structure
Physical Properties
Empirical formula: C25H35NO5.HCl
Mol. weight: 466.01 g/mol
Category: Anti-spasmodic drug
Physical state: White or almost white
crystalline powder
Melting point: 105–107°C
Odour: Odourless or with a slight
characteristic odour
Solubility: Freely soluble in ethanol (96%),
very soluble in water, insoluble in ether
Half-life: The mean elimination half-life is 2.5 h.
PHARMACOLOGY Mode of Action
Mebeverine is an antimuscarinic. It is also an
inhibitor of calcium-depot replenishment.
Musculotropic compounds act directly on the
gut muscles at the cellular level to relax them.
This relieves painful muscle spasms of the gut,
without affecting its normal motility.
Mebeverine is used to relieve symptoms of
irritable bowel syndrome and related intestinal
disorders that are the result of spasms in the
intestinal muscles.
These include colicky abdominal pain and
cramps, diarrhoea alternating with constipation
and flatulence [2, 3].
Pharmacokinetic Parameter
The plasma half-life of Mebeverine is reported
to be about 2.5 h; it is 60–75% bound to
TDD (2016) 23-32 © STM Journals 2016. All Rights Reserved Page 23
Trends in Drug Delivery ISSN: 2394-7268(online)
Volume 3, Issue 3
www.stmjournals.com
Quality by Design (QbD) Approach for Optimization and
Development of Nano Drug Delivery Systems
Daisy Arora1,2,*, Bharat Khurana
1,3, R.K. Narang
1, Sanju Nanda
2
1Department of Pharmaceutics, Nanomedicine Research Centre, I.S.F. College of Pharmacy, Moga,
Punjab, India 2Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana, India
3Department of Pharmacy, Maharaja Ranjit Singh Punjab Technical University, Bathinda, Punjab,
India
Abstract To clearly understand the formulation of high quality pharmaceutical products, FDA
generalized quality by design (QbD) in the field of pharmacy, which is based on the thorough
understanding of how materials and process parameters affect the quality profile of final
products. Quality by design is a risk management and science-based approach promoted by
the United States food and drug administration to enhance pharmaceutical development
throughout a product’s life cycle. The application of QbD in formulation and process design
of nano drug delivery systems is based on a good understanding of the sources of variability
and the manufacture process. In this paper, the basic knowledge of QbD, objectives and
elements of QbD are briefly reviewed. Tools for QbD implementation in pharmaceutics field,
including risk assessment, design of experiment, and process analytical technology (PAT), are
introduced briefly. Moreover, the actual applications of QbD in formulation of various
nanocarriers are summarized and presented.
Keywords: Quality by design, design of experiments, nanocarriers, risk management
INTRODUCTION Quality has been given abundant significance
by all regulatory bodies for manufacturing of
pharmaceutical products and drug delivery
systems. Quality means customer satisfaction
in terms of service, product, and process.
Customer demands the perfection in quality,
reliability, low cost and timely performance of
the drug product. But merely analyzing the
final product does indicate the quality;
however it should be designed in the product
[1, 2].
Thus the quality has to be built in the product
through proper planning, so that the impending
failure can be circumvented. Initially, quality
by test (QbT) was the solitary approach to
assure the quality of drug products which was
based on methods without clear understanding
of the processes. But after the launching of
guidelines for current good manufacturing
practice (cGMP) by FDA [3], this problem
was solved as FDA has also developed
generalized quality by design (QbD) in the
field of pharmacy [4]. Comparison between
QbT and QbD is shown in Figure 1. It is the
one limb of the quality system based on
building quality in the development phase and
all the way through a product’s life cycle. QbD
is based on the thorough understanding of how
materials and process parameters affect the
profile of final products [5, 6].
It can be underlined with risk management and
science mutually. International conference on
harmonization (ICH) defines QbD as “a
systematic approach to pharmaceutical
development that begins with predefined
objectives and emphasizes product and process
understanding and process control, based on
sound science and quality risk management”
[7]. QbD essentially means building quality in,
not testing it. Compared with traditional
quality by the testing (QbT) approach, QbD
has immense opportunities to build a well-
organized and flexible system with increased
manufacturing efficiency, reduced costs,
project rejections and waste.
TDD (2016) 33-36 © STM Journals 2016. All Rights Reserved Page 33
Trends in Drug Delivery ISSN: 2394-7268(online)
Volume 3, Issue 3
www.stmjournals.com
A Case Study: Efficacy of Panchakarma in a Case of
Lipidema with Fibromyalgia
Ish Sharma1,*, Aparna Sharma
2, Nancy Shahi
3
1Department of Rog Nidan, Babe Ke Ayurvedic Medical College and Hospital, Daudhar, Moga, India
2Department of Shalakya Tantra, The National Institute of Ayurveda, Jaipur, India
3Department of Samhita and Siddhant, Babe Ke Ayurvedic Medical College and Hospital,
Daudhar, Moga, India
Abstract Ayurveda can safely be applied to heal many difficult conditions [1]. A German female aged
45years was treated at Babe Ke Ayurveda College & Hospital, Daudhar, Moga, for a few
difficult conditions as lipidema and fibromyalgia. She received Panchakarma procedures viz.,
Rooksha Swedana, Virechana, Vasti and Nasya for 6 weeks and showed significant
improvement upon various signs and symptoms.
Keywords: Ayurveda, Virechana, Vasti, Nasya, Shaman treatment, lipidema, fibromyalgia
INTRODUCTION Ayurveda is a system of medicine with
historical roots in the Indian subcontinent [2].
Panchakarma is a unique detoxifying tool
from Ayurveda, having a potential to treat/cure
many refractive medical conditions [3].
Brihattrayi from Ayurveda have ample praises
for the 5-procedure protocol [4]. These five
procedures are Vamana (Emesis), Virechana
(Purgation), Nirooha Vasti (Decoction enema),
Nasya (Instillation of medicine through
nostrils), and Anuvasana Vasti (Oil enema).
Niruhana, Anuvasana form the basic types of
Vasti. The term Panchasodhana includes
Vamana, Virechana, Nasya, Niruhana, and
Raktamoksha [5–7].
Fibromyalgia has unknown origin and is
believed to be an autoimmune disorder, by and
large refractive to most treatments [8]. It is a
medical condition characterized by chronic
widespread pain and a heightened pain
response to pressure [9]. Other symptoms
include feeling tired to a degree that normal
activities are affected, sleep problems, and
troubles with memory [10]. Lipidema is an
incurable, chronically progressive affliction
that occurs almost exclusively in women. It
causes a symmetrical accumulation of fat in
the subcutaneous tissue that disproportionately
affects the lower limbs from buttocks to
ankles. The legs may also be sensitive and
prone to easy bruising. In some cases, the
upper arms can also accumulate distinct
patterns of fatty tissue [11, 12].
MATERIALS AND METHODS The Case
A 45 years old female German citizen of
Indian origin, reported with a 20 years history
of fibromyalgia and lipidema. Her body
weight was 76 kg. She has been on various
medications with little relief, resulting in
depression and a poor quality of life.
Major symptoms were pains all over the body,
fatty tissue deposits at the upper arms, thighs,
waist, back and abdomen (Table 1-4).
Drug Profile with Posology
Ghrit Pana for Virechana Panchatikta Ghrit was given for the purpose.
This is a medicated Ghrit containing Nimba
(Azadirachtaindica), Patola (Luffa
acutangula), Vyaghri (Solanum
xanthocarpum), Guduchi
(Tinosporacordifolia), Vasa (Adhatodavasica).
Swedana Material Common salt, 1 kg, heated to bearable
temperature in a bowl, made into 4 bolus of
250 gm each; applied lightly to deliver dry
fomentation.
TDD (2016) 37-41 © STM Journals 2016. All Rights Reserved Page 37
Trends in Drug Delivery ISSN: 2394-7268(online)
Volume 3, Issue 3
www.stmjournals.com
Curcumin: A Review on Methods for Enhancing Its
Bioavailability
Ruchika Goyal*, Sandeep Jain, Ashwani Kumar Drug Discovery and Research Laboratory, Department of Pharmaceutical Sciences, Guru
Jambheshwar University of Science and Technology, Hisar, Haryana, India
Abstract Curcumin is a natural polyphenolic compound which plays an important role in every
biological need from kitchen to drugs. Besides its too many applications, curcumin limits its
therapeutic value due to its less bioavailability, rapid excretion and metabolism. This review
presents the work of various researchers in the field of enhancing the bioavailability of
curcumin.
Keywords: Curcumin, bioavailability, methods
INTRODUCTION Turmeric, Curcuma Longa L. (Zingiberaceae),
has been attributed a number of medicinal
properties in the traditional system of
medicine for treating several common ailments
[1, 2]. In India and Nepal, turmeric rhizomes,
popularly known as ‘Haldi’ rhizomes, are used
as a household remedy. Curcumin [1,7-bis(4-
hydroxy-3-methoxy phenyl)-1,6-heptadiene-
3,5-dione] is the major yellow pigment
extracted from turmeric [3, 4]. Curcumin is
practically insoluble in water, but it is soluble
in ethanol or in dimethylsulfoxide. Curcumin
exists in equilibrium with its ketoenol
tautomeric form. The bis-keto form of
curcumin predominates in acidic and neutral
aqueous solutions and in cell membrane [5]. It
exhibits various biological functions like
wound healing ability [6, 7], antimicrobial
property [8, 9], hypochloesterolemic effects in
diabetic patients, antiproliferative activity
against various cancer cells [10],
antiangiogenic [11] and antiviral activity.
Curcumin and its derivatives also exhibit
antioxidant [12, 13] and anti-inflammatory
activity [14–16] as free radical mediated
peroxidation of membranes lipids and
oxidative damage of DNA and proteins are
believed to be associated with a variety of
chronic pathological conditions. Its ability to
inhibit cyclooxygenase-2 (COX-2),
lipoxygenase (LOX), and inducible nitric
oxide synthase (iNOS) leads to anti-
inflammatory property. Improper upregulation
of COX-2 and/or iNOS has been associated
with pathophysiology of certain types of
human cancer as well as inflammatory
disorders. People are now increasingly aware
of diet-related health problems and therefore,
looking for natural ingredients which are
expected to be safe and health-promoting.
Beside all the advantages, curcumin use is
limited due to its less bioavailability and rapid
metabolism.
In this review, we discussed the work done in
literature to overcome these drawbacks and to
make curcumin water soluble that result into
increase in its bioavailability.
CHEMISTRY OF CURCUMIN Firstly, curcumin was introduced in terms by
Trommsdorff in 1808 [17]; after that it was
isolated in impure form by Vogel and Pelletier
in 1810 from the rhizomes of turmeric [18]
and in pure crystalline form by Daube in 1870
[19]. Milobedeska and Lampe in 1910 gave
the chemical structure of curcumin as
diferuloylmethane [20, 21]. Curcumin is
known by its IUPAC name as 1,7-bis(4-
hydroxy-3-methoxyphenyl)-1,6-heptadiene-
3,5-dione, as the name suggests, it contains
two phenolic moiety linked with 1,6-
heptadiene-3,5-dione moiety.
Trends in
Drug Delivery(TDD)
September–December 2016
ISSN 2394-7268 (Online)
eISSN: 2394-7268
www.stmjournals.com
STM JOURNALSScientific Technical Medical