This document presents a research proposal on conducting a systematic review of oral formulations for common medical issues in infants in Malaysia. The proposal introduces the background, including that infants require specialized medicines due to physiological differences from adults. It identifies common symptoms such as fever, respiratory issues, diarrhea and vomiting. Commonly used drug classes and formulations are discussed. The proposal significance is that it will provide insights into oral medication practices for infants in Malaysia and highlight the need for specialized infant formulations. The aim is to study commonly used infant medications in Malaysia through a systematic review.
This document presents a research proposal on conducting a systematic review of oral formulations for common medical issues in infants in Malaysia. The proposal introduces the background, including that infants require specialized medicines due to physiological differences from adults. It identifies common symptoms such as fever, respiratory issues, diarrhea and vomiting. Commonly used drug classes and formulations are discussed. The proposal significance is that it will provide insights into oral medication practices for infants in Malaysia and highlight the need for specialized infant formulations. The aim is to study commonly used infant medications in Malaysia through a systematic review.
This document presents a research proposal on conducting a systematic review of oral formulations for common medical issues in infants in Malaysia. The proposal introduces the background, including that infants require specialized medicines due to physiological differences from adults. It identifies common symptoms such as fever, respiratory issues, diarrhea and vomiting. Commonly used drug classes and formulations are discussed. The proposal significance is that it will provide insights into oral medication practices for infants in Malaysia and highlight the need for specialized infant formulations. The aim is to study commonly used infant medications in Malaysia through a systematic review.
This document presents a research proposal on conducting a systematic review of oral formulations for common medical issues in infants in Malaysia. The proposal introduces the background, including that infants require specialized medicines due to physiological differences from adults. It identifies common symptoms such as fever, respiratory issues, diarrhea and vomiting. Commonly used drug classes and formulations are discussed. The proposal significance is that it will provide insights into oral medication practices for infants in Malaysia and highlight the need for specialized infant formulations. The aim is to study commonly used infant medications in Malaysia through a systematic review.
COMMON MEDICAL ISSUES IN MALAYSIA NARESH JAYABALAN QIUP 201710-001528 INTRODUCTION • Infants usually requires medicines that are specifically designed for them due to differences in development in terms of physiology, cognitive and motor skills compared to adults (Gerrard et al., 2019) • Advantages that provided by oral liquid dosage forms that makes it very popular among infants • Facilitate the ease of swallowing which makes administering it easier (Gerrard et al., 2019) • Lack of commercially available oral liquid dosage forms for infants leads to off label use of medicines for these group of patients • There are several problems associated with off label use of products I. Lack of access to various publications containing stability data on different drug formulations (Pai and Nahata, 2001) II. Lack of information about chemical, physical and microbiological stability data as well as short shelf life (Brion et al., 2003) (Giam and McLachlan, 2010) (Pai and Nahata, 2001) (Standing and Tuleu, 2005). III. Carry risk of lack of proof of dose uniformity (Costello et al., 2007) IV. Microbiological contamination in multidose off label preparations with insufficient preservation leads to potential risks, especially in the premature and newborns (Ghulam et al., 2007) V. Adverse drug reactions are difficult to assess in off label preparations due to presence of unknown excipients in commercially available preparations (Conroy S., 2008) VI. Significant difference in bioavailability between specialized preparations for infants, off label preparations, and manipulated medicines (Stevenson J., 2008). BACKGROUND OF STUDY List of Common Symptoms Among Infants for Various Disease Conditions • Fever • Respiratory related Symptoms • Diarrhea • Vomiting 1. Common Symptoms in Various Disease Conditions Medical Issue Explanation Reference Fever Sign of mild or more serious illness and causes of (Purssell, 2010) fever in infants include colds, flu, mumps, chickenpox, urinary and kidney infections, measles and teething Concern to many parents and may indicate more (Van Den Bruel et al., 2006) severe diseases such as bacterial infections like meningitis, septicaemia and urinary tract infection Most common complaint in paediatric emergency (Armon et al., 2001) department, accounting nearly 20% of paediatric emergency department visits Symptoms Explanation Reference Respiratory related Pneumonia-Becomes the cause for about 30-60% (Mitra NK., 2001) Symptoms 0f hospital visits around the world as well as 20- 30% of hospital admission for children
Children with pneumonia were have chief (Shaheen et al., 2017)
complaints such as fever, cough, runny nose, and sore throat and about 62.7% of paediatric patients had more than one respiratory symptoms Asthma-One of the chronic diseases in paediatrics (Kudzyte, J., Griska, E., & Bojarskas, & it more prevalent among paediatrics compared J., 2008) to adults (Ghaffari & Aarabi, 2013) An increase in evidence that paediatrics are (Mahashur, 2015) inappropriately treated for asthma based on cough as the solitary symptom Cough-Common medical problem in paediatric (Paramesh H., 2017) patient and most common paediatric problem managed by physicians Symptoms Explanation Reference Diarrhea Diarrhea during early infancy (children less than 2 (Thiagarajah et al., 2018) years of age) is relatively common, generally mild, and often self-limited
Causes of Diarrhea (Thiagarajah et al., 2018)
• Enteric viral or bacterial infections (Johnston et al., 2016) • Allergic disorders induced by exposure to food allergens, such as cow’s milk protein • Antibiotic induced diarrhea Vomiting Vomiting is a common symptom of numerous (Shields & Lightdale, 2018) underlying conditions for which children frequently present for healthcare
Causes of Vomiting (Shields & Lightdale, 2018)
• Viral gastroenteritis (Deborah M., 2020) • Gastroesophageal reflux disease • Food poisoning • Bowel obstruction 2. Commonly Used Medicines for Infant Related Disease Symptoms Class of Drug Drug Indication Reference Antipyretic Paracetamol Fever, pain Venkateswaramurthy et al., 2017 Ithnin et al., 2018 BOTZENHARDT et Al., 2016
NSAIDs Ibuprofen Fever, pain BOTZENHARDT et Al., 2016
Erythromycin et al., 2017 Shaheen et al., 2017 Ithnin et al., 2018 Meesala, 2017 Bronchodilators Salbutamol Asthma, cough Venkateswaramurthy et al., 2017 Ithnin et al., 2018 Palanisamy et al., 2012
Antihistamine Diphenhydramine Cough, common cold Pasupathi S., 2016
Chlorpheniramine Palanisamy et al., 2012 Mohamad et al., 2014 Cetrizine 3. Infant Oral Formulations Available • Available in the form of ready-to-use or require manipulation and multiuse or single use (Strickley, 2019) • Ready-to-use formulations • Oral solution, oral suspensions • Formulations Require Manipulations • Sprinkle capsule, powder for oral solution, powder for oral suspension, granules for oral suspension, oral powder oral granules, 4. Excipients Used in Paediatric Oral Formulations • Functions of Excipients in pharmaceutical dosage forms • Facilitate the manufacturing processes • Improve the stability of the preparations during the storage as well as usage (Burgess, 2017) • To mask the taste of drug and improve its stability during storage period (Van Riet- Nales et al., 2013) • Excipients used in paediatrics drug formulations may bring potential harm to infants. • They not able to metabolize the excipients used in the formulations as adults due the immaturity of their hepatic and renal system for metabolism and elimination (Burgess, 2017) • Use of preservative in paediatric formulations should be avoided and lowest feasible concentration only should be used if needed (Oishi S.,2004) 5. Global Regulations & Guidelines for Paediatric Drug Development • In 2007, World Health Organization (WHO) • Launched “make medicines child size” to increase awareness for more availability and accessibility to child specific medicines • Published guidance document in development of paediatric medicines which explains the development aspects of paediatric medicines such as desirable features of dosage form, flexible dosage form, formulation design, safe use of excipients and many others (Ch, Rasekaran, K, & Asamy, 2018) • In 2007, in Europe • Paediatric regulation was implemented for the development of paediatric specific drug products • 10 year market exclusivity can be under Paediatric use Marketing Authorization (PUMA) and 6 months of extension to Supplementary Protection Certificate (SPC) for paediatric drug products upon approval of Paediatric Investigation Plan (PIP) in Europe (Walsh, 2017). Problem Statement • Lack of specialized formulations for infants has resulted in increased use of off-label preparations, which maybe harmful to infants • Infants have limited capacity to swallow oral liquid preparations • Challenges to formulate concentrated low volume preparations using solid dosage forms Aim & Objective
Aim of the Study
• To study systemic review on commonly used infant medications in Malaysia
Objectives of the Study
• To identify common medical issues among infants in Malaysia • To identify management of common medical issues among infants in Malaysia • To identify pharmaceutical preparations for infants in Malaysia Significance of Study
• Will provide insight on oral medication practices for common medical
issues for infants in Malaysia • Will provide selection of suitable oral preparations for management of common medical issues for infants in Malaysia • The study will highlight the need for specialized oral medications for infants in Malaysia Research Methodology • Identification of commonly prescribed drugs for infants for common medical issues as per Ministry of Health, Malaysia official guidelines • Prescribing information will be obtained from various official sources from Ministry of Health, Malaysia and various research publications • The availability of registered dosage forms of drugs used in infants will be obtained from National Pharmaceutical Regulatory Agency (NPRA) official website. References