Priyadarshani Galappaththy

• MBBS, MD, MRCP(UK), DipMedTox, FRCP(Lond)
• Professor at University of Colombo

Resistant hypertension (RHTN) is defined as uncontrolled blood pressure despite treatment (>140/90 mmHg) with concurrent use of three antihypertensive agents of different classes, one of which should be a diuretic. A comparative analysis of the extended APPROPRIATE trial was conducted on measures of reactive nitrogen species (NO2-and NOx) and antio...

Objectives To perform a comparative analysis of the extended APPROPRIATE trial of measures of reactive nitrogen species and antioxidant capacity in patients having resistant hypertension with controlled hypertension and healthy controls. Results Mean serum NO2- and NOx levels were significantly lower and mean AOC was significantly higher in patien...

The plant species of the family Solanaceae contain trees, shrubs and herbs with natural compounds. The Solanum genus of this family accommodates diverse groups of flowering plants, which include medicinal plants and food crops. Among medicinal plants, Solanum melongena L., Solanum xanthocarpum L. and Solanum trilobatum L. are commonly used in the S...

Introduction Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available products, prices and affordability of essential medicines (EM) in community pharmacies in Sri Lanka...

Cinnamomum zeylanicum (CZ) is known to have numerous beneficial medicinal effects. The mechanism of action and compounds which account for these effects are not yet clearly defined. The present study aims to develop and validate a method to quantify the metabolites of CZ in human plasma and study its pharmacokinetic profile. Cinnamic acid (CA) was...

Introduction: Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available products, prices and affordability of essential medicines (EM) in community pharmacies in Sri Lank...

Background Patient’s knowledge on the medicines prescribed is vital in reducing medication errors and improving adherence and patient satisfaction. This study assessed the patients’ knowledge on medicines prescribed and compared improvement following verbal or written information given in patients own language. Methods Seventy-five trainee pharmac...

Background Sri Lanka is faced with the challenge of managing a large population with diabetes mellitus by 2030. Psychological stress plays a major role in disease outcome by exerting physiological, psychological and social effects on individuals with chronic disorders. Meditation-based interventions have positive effects on the management of stress...

Objectives To describe the availability of medicines and World Health Organization (WHO)/International Network of Rational Use of Drugs (INRUD) core drug use indicators in a nationally representative sample of outpatient department (OPD) pharmacies in government hospitals of Sri Lanka. Methods This descriptive-cross-sectional national survey was c...

Background: Identification of internationally comparable indicators of medicines use are important for a country to implement strategies and regulations to improve usage of medicines. Sri Lanka established a new National Medicines Regulatory Authority in 2015 and this survey evaluated the medication use indicators in Sri Lanka, according to the In...

Purpose: Aims of this study were to compare the bioequivalence of two formulations of amoxicillin 500 mg capsules under fasted and fed conditions in the same set of healthy volunteers, compare pharmacokinetics of amoxicillin under the two conditions and to assess the possibility of predicting in vivo bioequivalence of the two formulations using in...

Background: Diabetes mellitus, remains a metabolic disorder which is alarmingly rising in the world. It is characterized by hyperglycemia, and associates relative or absolute insulin deficiency or resistance. Disruption of the metabolism may cause lot of micro and macro vascular complications mostly affecting vital organs like kidneys, heart, eyes,...

Purpose Aims of this study were to compare the bioequivalence of two formulations of amoxicillin 500mg capsules under fasted and fed conditions in the same set of healthy volunteers, compare pharmacokinetics of amoxicillin under the two conditions and to assess the possibility of predicting in vivo bioequivalence of the two formulations using in vi...

Background: Drug related problems (DRPs) in prescriptions could result in patient harm. Objective: To assess the effectiveness of an educational workshop on detecting DRPs in prescriptions by a cohort of community pharmacists. Methods: Pharmacists working in a large community pharmacy chain in Sri Lanka were invited for an educational workshop on d...

This is a post-marketing study on prednisolone products in Sri Lanka conducted using BCS-based biowaiver procedures for performing in vitro bioequivalence studies. This study revealed the difficulties in low and middle-income countries (LMICs) when conducting biowaiver studies for regulatory submission and highlights the necessity to have bioequiva...

Irrational prescribing is common, especially in developing countries. It is important to identify the magnitude of irrational use, to take necessary steps to promote rational prescribing. We identified core prescribing indicators and commonly prescribed medicines at ward settings (IW) and outpatients’ clinics (OPC) in a tertiary care hospital in Sr...

Tinospora cordifolia (wild) Hook.f. (Thomas) is an important medicinal plant distributed throughout in Sri Lanka and commonly known as Rasakinda in Sinhala and Giloy in English. It is widely used in Sri Lankan traditional medical system and Ayurveda for the treatment of diabetes mellitus, fever, arthritis, skin diseases and for Rasayana (rejuvenati...

Objectives: The objective was to assess the effect of propranolol on oxidative stress and anti-oxidant potential in patients with resistant hypertension as a secondary analysis of the APPROPRIATE trial. This randomized double blinded clinical trial recruited patients with resistant hypertension and allocated forty patients to propranolol and place...

Cochrane Central Register of Controlled Trials: https://www.cochranelibrary.com/search

Background: Drug related problems (DRPs) in prescriptions could result in patient harm. Objective: To assess the effectiveness of an educational workshop on detecting DRPs in prescriptions by a cohort of community pharmacists. Methods: Pharmacists working in a large community pharmacy chain in Sri Lanka were invited for an educational workshop on d...

Phyllanthus niruri Linn belongs to plant family Euphorbiaceae and is found in tropical and subtropical countries of the world including some regions of Sri Lanka and India. The extract of P. niruri Linn is the most commonly used medicine in Ayurveda system of medicine and has especially been recommended for the treatment of bronchitis, anaemia, ski...

Objective: To assess sex-based differences in the prevalence of risk factor, their management, and differences in the prognosis among acute coronary syndrome (ACS) in Sri Lanka. Methods: Patients diagnosed with ACS were recruited from hospitals throughout the island. The Joint European Societies guidelines were used to assess recommended targets...

Objective. To assess sex-based differences in the prevalence of risk factor, their management, and differences in the prognosis among acute coronary syndrome (ACS) in Sri Lanka. Methods. Patients diagnosed with ACS were recruited from hospitals throughout the island. e Joint European Societies guidelines were used to assess recommended targets for...

Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne

Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose, and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive...

A comparative study on the pharmacognostical, phytochemical and physico-chemical studies of Solanum melongena L., Solanum xanthocarpum L. and Solanum trilobatum L. (Solanaceae), J. M. Dahanayake1, P. K. Perera1, P. Galappaththy2, L. D. A. M. Arawwawala3 1 Department of Dravyaguna Vignana, Institute of Indigenous Medicine, University of Colombo, Ra...

Background: Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive...

Background Allergic rhinitis (AR) is an immune response of the nasal mucosa to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. The symptoms of allergic rhinitis may significantly affect a patient’s quality of life and can be associated with conditions such as fatigue, headache, cognitive i...

Abstract Background Safety monitoring of medicines is essential during therapy for bipolar disorder (BD). We determined the extent of safety monitoring performed according to the International Society for Bipolar Disorders (ISBD) guidelines in patients with BD attending the main tertiary care psychiatry clinics in Sri Lanka to give realistic recomm...

The World Health Organization Global Patient Safety Challenge, Medication Without Harm, aims to reduce serious, avoidable medication-related harm by 50% in 5 years, globally. Three areas have been identified for early priority action. This technical report addresses Medication Safety in Transitions of Care; why it is a priority, what has been done...

The plant species of the family Piperaceae contain valuable natural compounds. Among the genera of Piperaceae family the Piper is an important genus which consists of 700 plant species growing in the different parts of the world. Many plants of this piper genus are the essential medicinal plants used in various traditional systems of medicine. Amon...

Background and objective: Tamalakyadi decoction (TD) is a classical formulation mentioned in authentic traditional medicine text Sarasankshepaya under nasal diseases and used as a remedy for allergic rhinitis. It consists of 12 plant ingredients. Decoction preparations are widely used in Sri Lankan traditional system and considered effective and s...

Background and study aims Allergic rhinitis is an immune response of the nasal mucosa (lining of the nasal cavities) to airborne allergens and involves nasal congestion, watery nasal discharge, itching of the nose and sneezing. Allergic rhinitis is commonly defined as seasonal or perennial, depending upon whether symptoms occur at defined yearly in...

Guidance documents on biowaivers and published literature, including the biowaiver monograph on amoxicillin, recommend conducting biopharmaceutics classification system (BCS)-based in vitro dissolution studies as a surrogate for in vivo bioequivalence (BE) studies for solid oral amoxicillin products. Until now, comparative in vitro dissolution stud...

Background: The regulatory requirements for approval of generic medicines and the format of compiling drug dossiers vary among regulatory authorities. The variation is particularly wide between High-income countries (HIC) and lower and middle-income countries (LMIC) with different regulatory frameworks. In this study, document requirements for app...

Tamalakyadi decoction (TD) is a classical formulation used in Sri Lankan traditional system of medicine for asthma, cough and allergic rhinitis. It consists of 12 plant ingredients. This decoction was modified as an instant dissolving powder form because decoction has a shorter shelf life and inconvenience of preparing fresh decoction every time wh...

Background: Drug Related Problems (DRPs) in prescriptions could result in patient harm. Purpose: To assess the impact of an educational workshop on detecting DRPs in prescriptions by a cohort of community pharmacists in Sri Lanka. Methods: Pharmacists working in a selected community pharmacy chain were invited from 14 districts in Sri Lanka. Partic...

Abstract: Carbamazepine (CBZ) is a first-line antiepileptic with a narrow therapeutic index. Therapeutic drug monitoring (TDM) of CBZ reduces toxicity and aids seizure control. Since routine TDM of CBZ is not done in Sri Lanka at present, a simple, accurate, and reliable high performance liquid chromatographic method with UV detection (HPLC-UV) was...

Carbamazepine (CBZ) is a first-line antiepileptic with a narrow therapeutic index. Therapeutic drug monitoring (TDM) of CBZ reduces toxicity and aids seizure control. Since routine TDM of CBZ is not done in Sri Lanka at present, a simple, accurate, and reliable high performance liquid chromatographic method with UV detection (HPLC-UV) was developed...

Background Management of epilepsy during pregnancy in a resource-limited setting (RLS) is challenging. This study aimed to assess obstetric outcomes and effects on babies of women with epilepsy (WWE) exposed to Anti-epileptic drugs (AEDs) compared to non-exposed controls in a RLS. Methods Pregnant WWE were recruited from antenatal and neurology cli...

Background. Adherence to long-term therapy for diabetes remains low. Accurately measuring adherence is the primary step in improving adherence. We translated and validated the Sinhalese version of the Brief Medication Questionnaire (BMQ) in patients with diabetes. Methods. The study was conducted at the National Hospital of Sri Lanka between April...

Annexure 1: Sinhalese translation of the Brief Medication Questionnaire used for validation.

An important component of evaluation of generic medicines is assessing their therapeutic equivalence, which is done by a comparative study with an appropriate comparator, such as an in vivo bioequivalence study or an in vitro dissolution study. In vivo bioequivalence studies are cumbersome and expensive. Their need might be waived using in vitro di...

Rationale, aims and objectives: The Morisky Medication Adherence Scale (MMAS-8) is a self-reported scale used in assessing medication adherence in patients on chronic therapy. Medication adherence is a neglected area of research in Sri Lanka and in this study we have attempted to validate the Sinhala translation of the MMAS-8 to determine medicatio...

Several depigmenting agents are now available both for topical and systemic use with varying degrees of evidence on their efficacy and safety. These agents act by inhibiting melanogenesis, interrupting melanosome transfer, accelerating epidermal desquamation with melanin turnover, antioxidant effects and by other methods. The topical agents that ac...

Background Ischaemic heart disease is the leading cause of in-hospital mortality in Sri Lanka. Acute Coronary Syndrome Sri Lanka Audit Project (ACSSLAP) is the first national clinical-audit project that evaluated patient characteristics, clinical outcomes and care provided by state-sector hospitals. Methods ACSSLAP prospectively evaluated acute ca...

Abstract Background Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in...

Background: To evaluate the effects of Zinc supplementation on glycaemic control, other cadio-metabolic/anthropometric parameters and progression of disease in pre-diabetes. Methods: The clinical trial was conducted as a randomized, double-blind, placebo-controlled Phase II clinical trial for a period of 12 months. The treatment group received Z...

Background Previous studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of...

As anaphylaxis is a medical emergency, there are no randomized controlled clinical trials on its emergency management. Therefore, current guidelines are mostly based on data from observational studies, animal and laboratory studies. Although epinephrine is the mainstay of recommended treatment, corticosteroids are also frequently used. This review...

Background: The medical community is increasingly using Portable Electronic Devices (PEDs). We evaluated usage of PEDs and medical apps among medical students from Sri Lanka. Methods: This descriptive cross-sectional study was conducted at Faculty of Medicine, University of Colombo. Medical students from 2nd to 5th year were invited for the stud...

Background: The standard dose of rituximab used in rheumatoid arthritis (RA) is 1000 mg but recent studies have shown that low dose (500 mg) is also effective. Efficacy of low dose rituximab in rheumatoid arthritis (RA) refractory to first-line non-biologic Disease Modifying Anti Rheumatic Drugs (DMARDs), compared to leflunomide is unknown. In a t...

Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), therapeutic uses, therapeutic index,...

Abstract Purpose: In-vitro and in-vivo studies in animals suggests that Ceylon Cinnamon has anti-microbial, anti-parasitic, anti-oxidant and free radical scavenging properties. This article summarizes the study protocol for a Phase-I clinical trial in humans. Methods: The study will be conducted as a phase-I clinical trial for a period of 3 months...

Background: Resistant hypertension is defined as an uncontrolled blood pressure despite treatment at best-tolerated doses with at least three antihypertensive agents including a diuretic. It is an emerging public health problem. At present clinical trial data on management of resistant hypertension is limited. Management is largely based on observ...

Objectives: To compare the pregnancy outcomes and contraceptive practices in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and women with no chronic illness (WNCI) in a tertiary care referral center in Colombo, Sri Lanka. Methods: Patients with SLE satisfying American College of Rheumatology criteria for diagnosis and history of...

Background Leg edema is a common adverse effect of dihydropyridine Calcium Channel Blockers (CCB) that may need dose reduction or drug withdrawal, adversely affecting the antihypertensive efficacy. Leg edema is reported to occur less often with (S)-amlodipine compared to conventional racemic amlodipine. We aimed to find the incidence of leg edema a...

Backgrounds: Biowaiver(BW) monographs pertaining to waiving of in vivo bioequivalence(BE) are available for drugs belonging to Biopharmaceutics Classification System(BCS) class 1 and III. World Health Organization(WHO) classifies amoxicillin to BCS class 1 but no BW monograph is available as yet. We reviewed literature relevant to a BW monograph fo...

Backgrounds: Biopharmaceutics Classification System(BCS) based biowaiver(BW) studies are acceptable for determining bioequvalance(BE) of drugs belonging to BCS class I and some class III Drug regulatory authority(DRA) of Sri Lanka(SL) currently does not use BW criteria in generic drug registration. Purpose: To apply BCS based BW criteria for 3 sele...

Background: Diabetes mellitus is a leading cause of morbidity and mortality worldwide. Studies have shown that Zinc has numerous beneficial effects in both type-1 and type-2 diabetes. We aim to evaluate the literature on the mechanisms and molecular level effects of Zinc on glycaemic control, β-cell function, pathogenesis of diabetes and its compl...

Bioequivalence studies conducted in healthy volunteers are the usually accepted method to determine the therapeutic equivalence of two drug products. As these in vivo bioequivalence studies are time consuming and expensive to conduct, major regulatory authorities now accept biowaiver studies, using in vitro dissolution testing, for selected drugs b...

Zinc is a mineral that plays a vital role in many biological processes and plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Numerous studies have evaluated the effects of Zinc supplementation on serum lipids in humans and have demonstrated varying results....

Bioequivalence studies are the usually accepted method to determine the therapeutic equivalence of two drugproducts. Because in-vivo bioequivalence studies are time consuming and expensive to conduct, majorregulatory authorities have introduced biowaivers for some selected medicines belonging to BCS class 1 andIII drugs. Comparative dissolution tes...

Bioequivalence studies are the usually accepted method to determine the therapeutic equivalence of two drug products. Because in-vivo bioequiva-lence studies are time consuming and expensive to conduct, major regulatory authorities have introduced biowaivers for some selected medicines belonging to BCS class 1 and III drugs. Comparative dissolution...

In traditional medicine Cinnamon is considered a remedy for respiratory, digestive and gynaecological ailments. In-vitro and in-vivo studies from different parts of the world have demonstrated numerous beneficial medicinal effects of Cinnamomum zeylanicum (CZ). This paper aims to systematically review the scientific literature and provide a compreh...

Cytochrome P450 2D6 (CYP2D6) enzymes are involved in the metabolism of a large number of commonly prescribed drugs such as antidepressants and cardiovascular drugs. The CYP2D6 *3, *4 and *14 variants associated with the loss of enzyme function; CYP2D6 *10 and *17 variants with reduced enzyme function; and CYP2D6 *2 variant with no effect on enzyme...

Background The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those...

We thank Akilen and colleagues for their considered comments on our systematic review and meta-analysis [1]. Firstly; we would like to clarify our position regarding the coumarin content of Cinnamomum aromaticum (cassia cinnamon), as opposed to Cinnamomum zeylanicum, based on the literature that is currently available. According to the German Feder...

Aims: Diabetes is a leading cause of morbidity and mortality worldwide. Studies have frequently looked at dietary components beneficial in treatment and prevention. We aim to systematically evaluate the literature on the safety and efficacy of Cinnamomum zeylanicum on diabetes. Methods: A comprehensive search of the literature was conducted in t...

Abstract The number of people with diabetes and pre-diabetes are exponentially increasing. Studies on humans have shown the beneficial effects of Zinc supplementation in patients with diabetes. The present study aims to systematically evaluate the literature and meta-analyze the effects of Zinc supplementation on diabetes. A systematic review of pu...

Forest plots showing effects of Zinc Supplementation alone on; a) Fasting Blood Glucose (FBG), b) 2-hr Post Prandial Blood Glucose (2-hr PPBS), c) Glycosylated Haemoglobin (HbA1C) (IV-Inverse variance)

Forest plots showing effects of Zinc Supplementation alone on; a) Total Cholesterol (TC), b) LDL Cholesterol, c) HDL Cholesterol, d) Triglycerides (TG) (IV-Inverse variance)

Autoimmune joint diseases occur due to uncontrolled abnormal immune responses (autoimmunity). The commonest autoimmune diseases seen in clinical practice are rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and un-differentiated arthritis. These are a source of significant morbidity and some mortality within the population. Non-bio...