eISSN: 2394-7268 ISSN 2394-7268 (Online)
Trends in
Drug Delivery (TDD) September–December 2016
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Trends in Drug Delivery
Contents
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
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, RajkotBhavnagar 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) 1-19 © STM Journals 2016. All Rights Reserved
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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-(4methoxyphenyl)propan-2-yl]amino]butyl 3,4dimethoxybenzoate;hydrochloride [2]. Chemical Structure
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].
Physical Properties Empirical formula: C25H35NO5.HCl Mol. weight: 466.01 g/mol Category: Anti-spasmodic drug
Pharmacokinetic Parameter The plasma half-life of Mebeverine is reported to be about 2.5 h; it is 60–75% bound to
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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 Khurana1,3, R.K. Narang1, Sanju Nanda2 1
Department of Pharmaceutics, Nanomedicine Research Centre, I.S.F. College of Pharmacy, Moga, Punjab, India 2 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana, India 3 Department 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 wellorganized and flexible system with increased manufacturing efficiency, reduced costs, project rejections and waste.
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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 Sharma2, Nancy Shahi3 1
Department of Rog Nidan, Babe Ke Ayurvedic Medical College and Hospital, Daudhar, Moga, India 2 Department of Shalakya Tantra, The National Institute of Ayurveda, Jaipur, India 3 Department 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.
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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(4hydroxy-3-methoxy phenyl)-1,6-heptadiene3,5-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 antiinflammatory 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(4hydroxy-3-methoxyphenyl)-1,6-heptadiene3,5-dione, as the name suggests, it contains two phenolic moiety linked with 1,6heptadiene-3,5-dione moiety.
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