حمد صالح اليامي

 


      
 
الاسم الاول: 
حمد
اسم العائلة: 
اليامي
الدرجة العلمية: 
دكتوراة
مجال الدراسة: 
الطب والخدمات الصحية
المؤسسة التعليمية: 
Aston University

مجال التميز

تميز دراسي و بحثي

 

 

البحوث المنشورة

 

البحث (1):

 

عنوان البحث:

Evidence-Based   Nanoscopic and Molecular Framework   for Excipient Functionality in Compressed Orally   Disintegrating Tablets

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تاريخ النشر:

 15/07/2014

 

 

 

 

 

 

 

 

موجز عن البحث:

 

The work investigates the adhesive/cohesive molecular and physical interactions together with nanoscopic features of commonly used orally disintegrating tablet (ODT) excipients microcrystalline cellulose (MCC) and D-mannitol. This helps to elucidate the underlying physico-chemical and mechanical mechanisms responsible for powder densification and optimum product functionality. Atomic force microscopy (AFM) contact mode analysis was performed to measure nano-adhesion forces and surface energies between excipient-drug particles (6-10 different particles per each pair). Moreover, surface topography images (100 nm2–10 mm2) and roughness data were acquired from AFM tapping mode. AFM data were related to ODT macro/microscopic properties obtained from SEM, FTIR, XRD, thermal analysis using DSC and TGA, disintegration testing, Heckel and tabletability profiles. The study results showed a good association between the adhesive molecular and hysical forces of paired particles and the resultant densification mechanisms responsible for mechanical strength of tablets. MCC micro roughness was 3 times that of D-mannitol which explains the high hardness of MCC ODTs due to mechanical interlocking. Hydrogen bonding between MCC particles could not be established from both AFM and FTIR solid state investigation. On the contrary, D-mannitol produced fragile ODTs due to fragmentation of surface crystallites during compression attained from its weak crystal structure. Furthermore, AFM analysis has shown the presence of extensive micro fibril structures inhabiting nano pores which further supports the use of MCC as a disintegrant. Overall, excipients (and model drugs) showed mechanistic behaviour on the nano/micro scale that could be related to the functionality of materials on the macro scale.

 

 

البحث (2):

 

عنوان البحث:

A Systematic Investigation of D-Mannitol Functionality in the Development of Age-Appropriate Formulations

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تاريخ النشر:

10/10/2013

 

موجز عن البحث:

 

Advances in the field of oral solid dosage forms have seen the introduction of technologies specifically aimed for drug delivery of candidates to children and elderly individuals.1 The main hurdle being faced with these target patient populations is the difficulty of swallowing solid bulky dosage forms. This obstacle has led to the development of orally disintegrating tablets (ODTs) and recently to the influx of various methodologies to manufacture them, including the cost-effective direct compression method. Preliminary powder flow characterization of D-mannitol (particle size distribution 37–50 mm) was carried out using a static angle of repose test. This was followed by assessment of the mechanical properties of ODTs by measuring the hardness of compacts of D-mannitol (99.5%, w/w) with 0.5% (w/w).

 

 

البحث (3):

 

عنوان البحث:

Microparticle surface layering through dry coating: impact of moisture content and process parameters on the properties of orally disintegrating tablets

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تاريخ النشر:

26/07/2016

موجز عن البحث:

 

Objectives:  The aim of this study was to investigate the influence of process parameters during dry coating on particle and dosage form properties upon varying the surface adsorbed moisture of microcrystalline cellulose (MCC), a model filler/binder for orally disintegrating tablets (ODTs).

Methods: The moisture content of MCC was optimised using the spray water method and analysed using thermogravimetric analysis. Microproperty/macroproperty assessment was investigated using atomic force microscopy, nanoindentation, scanning electron microscopy, tablet hardness and disintegration testing.

Key findings: The results showed that MCC demonstrated its best flowability at a moisture content of 11.2% w/w when compared to control, comprising of 3.9% w/w moisture. The use of the composite powder coating process (without air) resulted in up to 80% increase in tablet hardness, when compared to the control. The study also demonstrated that surface adsorbed moisture can be displaced upon addition of excipients during dry processing circumventing the need for particle drying before tabletting.

Conclusions: It was concluded that MCC with a moisture content of 11% w/w provides a good balance between powder flowability and favourable ODT characteristics.

 

 

البحث (4):

 

عنوان البحث:

Dosage form preference consultation study in children and young adults: paving the way for patient-centred and patient-informed dosage form development

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تاريخ النشر:

02/09/2016

موجز عن البحث:

 

Objectives: The current study aims to evaluate dosage form preferences in children and young adults together with identifying the key pragmatic dosage form characteristics that would enable appropriate formulation of orally disintegrating tablets (ODTs).

Methods: International, multisite, cross-sectional questionnaire of children and young adults aged from 6 to 18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications. The study was carried out at three locations: the UK, Saudi Arabia and Jordan. The questionnaire instrument was designed for participant self-completion under supervision of the study team.

Results: 104 questionnaires were completed by the study cohort (n=120, response rate 87%). Results showed that ODTs were the most preferred oral dosage forms (58%) followed by liquids (20%), tablets (12%) and capsules (11%). The preferred colours were pink or white while the preferred size was small (<8 mm) with a round shape. With regard to flavour, strawberry was the most preferred (30.8%), while orange was the least preferred (5.8%). The results also showed that the most important physical characteristics of ODTs were disintegration time followed by taste, size and flavour, respectively.

Conclusions: The results of our study support the WHO's claim for a shift of paradigm from liquid towards ODTs dosage forms for drug administration to young children older than 6 years. Data from this study will also equip formulators to prioritise development of key physical/performance attributes within the delivery system.

 

 

المؤتمرات العلمية:

 

المؤتمر (1):

 

عنوان المؤتمر:

Saudi Students Conference (SSC2014)

تاريخ الإنعقاد:

1-2/02/2014

مكان الإنعقاد:

Scotland - Edinburgh - UK

طبيعة المشاركة:

Poster

عنوان المشاركة:

Formulation and process development  of  oral disintegrating tablets (ODTs) - systematic investigation into the role of Microcrystalline cellulose (MCC) using direct compression

 ملخص المشاركة:

 

The last decade, has brought increased demand for oral disintegrating tablets (ODTs), and the field has become a fast growing area in the pharmaceutical industry because of the problem of dysphagia in paediatric and geriatric patients.

The aim of this study was to formulate ODT with low disintegrating time by using different concentrations of microcrystalline cellulose (MCC). The main objective of this study was to investigate the feasibility of incorporating therapeutic doses of active drugs, such as, theophylline and ibuprofen, in ODTs based on MCC and mannitol as diluents at various compression pressures. The hardness, friability, and disintegration time, tablet index, and porosity, for each ratio was determined. Weight, diameter, thickness, volume, bulk density and true density were determined as well. Data groups were compared using one- way analysis of variance (ANOVA) and the significant differences were determined. It was found that at 2 tonnes pressure the tablet index (TI) was highest, as the higher the value of tablet index, the higher the hardness and lower is disintegration time. Results obtained from preparation of MCC (2%, 5%, 10%, 15%, and 30%), mannitol and 0.5% magnesium stearate showed that at 30% MCC, tablet index was highest with 15.7 seconds disintegration time and 94 Newton hardness. The next stage of the experimental set- up was to investigate the feasibility of delivering therapeutic doses of ibuprofen (insoluble drug) and theophylline (water soluble drug). The results showed that optimum formulation of ibuprofen ODT at a dose of 200 mg was achieved at 1.5 tonnes in the presence of 30% MCC. It was also found that 200 mg of theophylline at 50% MCC at 2 tonnes was the most efficient ODT formulation. Based on experimental data, it was evident that concentration of MCC plays a major role in the formulation of ODTs.

 

 

المؤتمر (2):

 

عنوان المؤتمر:

42nd CRS Annual Meeting and Exposition

تاريخ الإنعقاد:

26-29/07/2015

مكان الإنعقاد:

Edinburgh, UK

طبيعة المشاركة:

Paper presentation

عنوان المشاركة:

International Acceptability Study of Orally Disintegrating Tablets (ODTs) in Children and Yong Adults

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ملخص المشاركة:

 

Following the European Regulation for paediatric formulations, the demand for the production of paediatric dosage forms has escalated. Managing the clinical needs of children is challenging, especially as this must often be accomplished using adult medicine formulations.

The current study aims to evaluate dosage form preferences in children and young adults along with assessing the key pragmatic dosage form characteristics that would enable formulation of patient centered orally disintegrating tablets.

 

INTRODUCTION:

Paediatric drug administration is one area of the medical field that has gained significant attention over the last five to seven years. Pharmacists and other healthcare professionals in the drug manufacturing industry face a myriad of difficulties with regard to administration of drugs to young people.

The main challenge facing drug manufacturing and production is the appropriate choice of the dosage forms for drug administration to these target population [1]. For this reason, the common trend has been the manipulation of adult dosage forms into a form that can be administered to children. The European Regulation on medicinal products stipulates that all formulations produced for young people should be in line with safety measures and should generally be acceptable to the target population [2].

The authors in this publication designed the current study with two key objectives central to the study: evaluation and understanding dosage form preferences among children and young adults who have a history of taking medicines and secondly extracting data on key dosage form performance parameters in the manufacture of orally disintegrating tablets. The study was conducted in three regions (UK, Saudi Arabia and Jordan) at five different centers. These included Birmingham children hospital, Nottingham children hospital (UK), Najran maternity and children hospital, General Thar hospital (Saudi Arabia) and Specialty hospital in Jordan.

 

EXPERIMENTAL METHODS:

This study was a multi-centre; randomized, open (non- blinded) cross-over study of children and young adults between the ages of 6-18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications.

The survey instrument was designed for participant self-completion under supervision of the study team. The study was created in MS Word and included demographics and oral dosage form preferences. Questionnaires were completed following a short, non-promotional, demonstration of ODTs.

The questionnaire consisted of four sections. The first section gathered information regarding demographic and educational data including gender, age, and education. The second section comprised of a set of questions regarding children experience of taking medicines and their preferences for various dosage forms. The third section of the questionnaire contained questions regarding physical characteristics such as, preference for color, shape, size, thickness, taste, and flavor and disintegration time of tablets. In the last section of the questionnaire, children were asked about their feedback on the questionnaire.

 

RESULTS AND DISCUSSION:

One hundred and four questionnaires out of one hundred and twenty were completed over three different countries.

The table below (table 1) gives the demographic characteristics of the participants. It gives the breakdown of their gender, age and educational level. The table also sheds more light on the P value for the different characteristics. The demographic characteristics were used to calculate the P value.

Table1. Demographic characteristics of participants

 

In our study,the chart below shows the preferred oral dosage forms among the paediatric population. It indicated that ODTs were the most popular oral dosage forms (58%) followed by liquids (19%), tablets (12%) and capsules (11%). On the other hand, study by  Ibrahim  (2010) showed that the capsules were the most prefered oral solid dosage forms when compared to tablets, caplets and soft gel[3].

 

Figure1. Distribution of the preferred oral dosage forms among pediatrics in all regions

 

The results obtained for the analysis of the physical characteristics of ODTs showed that quarter of the participants (25.0%) rated the duration for tablet disintegration in the mouth as the most important characteristic followed by the taste (24.05%), size (15.71%), and flavor (13.78%) respectively as shown in figure 2.

Figure2. Distribution of the most preferred      characters of ODTs for All regions

 

Findings from this study propose that the formulation of ODTs and their physical characteristics are of high importance in encouraging patients to continue using a particular medicine. Additionally, they are important factors in influencing initial selection of products available in the market especially with OTC medications.

 

CONCLUSION:

The general feeling was that orally disintegrating tablets are a pragmatic dosage forms for children and young adults. The benefits that accrue to this dosage form include safety, higher compliance, dose accuracy, stability and ease of swallowing. Within the pediatric population, orally disintegrating tablets are more convenient because they combine the advantages of both solid and liquid dosage forms but without incorporating their disadvantages such as difficulty in swallowing and lack of stability respectively. From the results in the current study, it can be concluded that the most preferred colors were pink and white, the most preferred size is the small sized tablets and the most preferred shape was round. Similarly, physical characteristics with regard to the acceptability of ODTs included disintegration time, taste, size and flavor.

 

 

المؤتمر (3):

 

عنوان المؤتمر:

9th Saudi Students’ Conference

تاريخ الإنعقاد:

13-14/02/2016

مكان الإنعقاد:

Birmingham, UK

طبيعة المشاركة:

Poster presentation

عنوان المشاركة:

Global Consultation Study of Orally Dissolving Tablets (ODTs) in Paediatric Population

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ملخص المشاركة:

 

Following the European Regulation for paediatric formulations, the demand for the production of paediatric dosage forms has escalated. Managing the clinical needs of children is challenging, especially as this must often be accomplished using adult medicine formulations.

The current study aims to evaluate dosage form preferences in children and young adults along with assessing the key pragmatic dosage form characteristics that would enable formulation of patient centered orally disintegrating tablets.

 

INTRODUCTION:

Paediatric drug administration is one area of the medical field that has gained significant attention over the last five to seven years. Pharmacists and other healthcare professionals in the drug manufacturing industry face a myriad of difficulties with regard to administration of drugs to young people.

The main challenge facing drug manufacturing and production is the appropriate choice of the dosage forms for drug administration to these target population [1]. For this reason, the common trend has been the manipulation of adult dosage forms into a form that can be administered to children. The European Regulation on medicinal products stipulates that all formulations produced for young people should be in line with safety measures and should generally be acceptable to the target population [2].

The authors in this publication designed the current study with two key objectives central to the study: evaluation and understanding dosage form preferences among children and young adults who have a history of taking medicines and secondly extracting data on key dosage form performance parameters in the manufacture of orally disintegrating tablets. The study was conducted in three regions (UK, Saudi Arabia and Jordan) at five different centers. These included Birmingham children hospital, Nottingham children hospital (UK), Najran maternity and children hospital, General Thar hospital (Saudi Arabia) and Specialty hospital in Jordan.

EXPERIMENTAL METHODS:

This study was a multi-center; randomized, open (non- blinded) cross-over study of children and young adults between the ages of 6-18 years. Eligibility was based on age, ability to communicate and previous experience in taking medications.

The survey instrument was designed for participant self-completion under supervision of the study team. The study was created in MS Word and included demographics and oral dosage form preferences. Questionnaires were completed following a short, non-promotional, demonstration of ODTs.

The questionnaire consisted of four sections. The first section gathered information regarding demographic and educational data including gender, age, and education. The second section comprised of a set of questions regarding children experience of taking medicines and their preferences for various dosage forms. The third section of the questionnaire contained questions regarding physical characteristics such as, preference for color, shape, size, thickness, taste, and flavor and disintegration time of tablets. In the last section of the questionnaire, children were asked about their feedback on the questionnaire.

RESULTS AND DISCUSSION:

One hundred and four questionnaires out of one hundred and twenty were completed over three different countries.

The table below (table 1) gives the demographic characteristics of the participants. It gives the breakdown of their gender, age and educational level. The table also sheds more light on the P value for the different characteristics. The demographic characteristics were used to calculate the P value.

Table1. Demographic characteristics of participants

 

In our study ,the chart below shows the preferred oral dosage forms among the paediatric population. It indicated that ODTs were the most popular oral dosage forms (58%) followed by liquids (19%), tablets (12%) and capsules (11%). On the other hand, study by  Ibrahim  (2010) showed that the capsules were the most preferred oral solid dosage forms when compared to tablets, caplets and soft gel[3].

The results obtained for the analysis of the physical characteristics of ODTs showed that quarter of the participants (25.0%) rated the duration for tablet disintegration in the mouth as the most important characteristic followed by the taste (24.05%), size (15.71%), and flavor (13.78%) respectively as shown in figure 1.

Figure1. Distribution of the most preferred      characters of ODTs for All regions

 

Findings from this study propose that the formulation of ODTs and their physical characteristics are of high importance in encouraging patients to continue using a particular medicine. Additionally, they are important factors in influencing initial selection of products available in the market especially with OTC medications.

CONCLUSION:

The general feeling was that orally disintegrating tablets are a pragmatic dosage forms for children and young adults. The benefits that accrue to this dosage form include safety, higher compliance, dose accuracy, stability and ease of swallowing. Within the paediatric population, orally disintegrating tablets are more convenient because they combine the advantages of both solid and liquid dosage forms but without incorporating their disadvantages such as difficulty in swallowing and lack of stability respectively. From the results in the current study, it can be concluded that the most preferred colors were pink and white, the most preferred size is the small sized tablets and the most preferred shape was round. Similarly, physical characteristics with regard to the acceptability of ODTs included disintegration time, taste, size and flavor.

المؤتمر (4):

 

عنوان المؤتمر:

2016 UKICRS Symposium

تاريخ الإنعقاد:

21-22/04/2016

مكان الإنعقاد:

Cardiff, UK

طبيعة المشاركة:

Poster presentation

عنوان المشاركة:

Formulation and process development of pediatric ODTs: A systematic investigation into the role of moisture content on  micro/macro properties of pharmaceutical excipients

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ملخص المشاركة:

 

Background: The amount of water related with solids may meaningfully affect physical and mechanical properties of pharmaceutical materials. Properties such as powder flow, powder coating, AFM, nanoindntaion, compaction, hardness, friability, disintegration time are influenced by moisture content. This study aims to examine the effect of moisture sorption of Micro Crystalline Cellulose (MCC) on powder blending/coating using a prototype dry powder coater and consequent tableting by direct compression.

Methods: The moisture content of MCC was optimized using spray water approach and analysed using thermogravimetric analysis (TGA). Selected particle sizes of both mannitol (guest particle size ≤ 38 μm) and MCC (carrier particle size ≥ 250 μm) were obtained by sieving and confirmed by particle size analyzer. Two different blends of the mixture of MCC and mannitol were studied: interactive mixtures obtained by blending the mix at 300rpm for 5 minutes and particle coated mix obtained by blending at 1500 rpm either with or without air flow.  Consequential ODTs of powder blend (interactive mixture) and powder coating (with and without air) were investigated for hardness, friability, disintegration time and porosity.

 

Results: The results showed that as moisture content of MCC increases, the flow properties improve dramatically. MCC demonstrated its best flowability at moisture content of 11.2%, (low angle of repose 29.6±0.86) when compared to control comprising of 3.9% moisture (angle of repose 38.52±0.67). This difference in flow could possibly be attributed to the lubricant activity of moisture that reduces the friction between particles and the solid surface. The next sets of investigations were focused at developing interactive and dry particle coated (mannitol coated on to MCC) mixtures of MCC with different moisture content (3.9% and 11.2%).  The results showed that formation of interactive mixtures resulted in a drop of moisture content from 3.9% to 1.6and from 11.2% to 2.6 Similarly, upon dry coating without air the moisture content dropped from 3.9% to 1.7 and from 11.2% to 4.12 Interestingly, inclusion of air flow within the process of dry coating reduced the moisture content from 3.95 to1.7 and 11.2% to 1.5 These differences in moisture content of the powder blends, due to variations in processing conditions demonstrated significant variations in ODT properties. Stronger compacts were obtained from interactive mixtures for the two different levels of moisture content for MCC whereas dry coated powder blends (with and without air) yielded weaker ODTs. These differences in ODT properties are due to the differences in the moisture content which cements the particles and impacts on mechanical properties as well as particle layering with mannitol coated MCC presenting fragment able surfaces which result in weaker tablets.

Conclusions: Moisture considerably affects the consolidation characteristics of blended powder. The extent of consolidation and the bonding of particles not exclusively on moisture content but also on the powder processing conditions.

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