Tablet Formulation Research Articles

A One-Step Green Microwell Spectrophotometric Assay for the Determination of Certain New Chemotherapeutic Drug Formulations.

The formation of charge-transfer complexes (CTCs) of iodine with five chemotherapeutic drugs used for the treatment of different types of cancer has not been investigated. These drugs are olaparib, seliciclib, vandetanib, dasatinib, and tozasertib. Additionally, these drugs need an appropriate general spectrophotometric assay for their analysis in the dosage forms regardless of the differences in their chemical structures. The aim of this study was the development of a novel microwell spectrophotometric assay (MW-SPA) for one-step determination of these drugs via their interactions with iodine, which resulted in instantaneous production of bright lemon-yellow CTCs. A spectrophotometric study of the CTCs was conducted, and all CTCs were characterized. Site(s) of interaction on each drug were assigned, and the MW-SPA was developed and applied to the analysis of dosage forms. The findings confirmed that the reactions proceeded via CTC formation. Beer's law was obeyed over a general concentration range of 1-6 µg/mL. The LODs and LOQs were in the ranges of 0.5-2.1 and 1.5-6.4 µg/mL, respectively. The proposed MW-SPA demonstrated excellent precisions as the relative standard deviations were < 2.24 and 2.23% for the intra- and inter-assay precision, respectively. Recovery studies demonstrated the accuracy of MW-SPA. Successful determination of all drugs in bulk and tablet forms was achieved using the MW-SPA. The environmental sustainability of the proposed methodology was determined, providing evidence of the assay's alignment with the basis of green analytical chemistry. The high throughput of the assay was documented. In contrast to other existing methods, the MW-SPA described herein was valid for analyzing all drugs at the same wavelength. The assay is useful for routine analysis of drugs in their formulations in QC laboratories.

Development of a Stability-Indicating Purity Method for Ubrogepant Through Stress Degradation Analysis, Extraction, and Characterization of Unidentified Degradation Products Using Flash Chromatography, NMR, IR, and LC–MS

Abstract Background Ubrogepant is a prescription medication used to prevent migraine headaches. It is currently available in tablet form. Objective The goal of this work is to investigate the drug degradation profile of ubrogepant, as well as to isolate and characterize undiscovered ubrogepant degradation products by utilizing LC–MS, NMR, and IR spectroscopic analytical techniques and, furthermore, to develop a high-resolution, sensitive, stability-indicating analytical approach for detecting and quantifying ubrogepant degradation products in its pharmaceutical formulation. Methods To identify and quantify the degradation products of ubrogepant in pharmaceutical products, a novel gradient reverse-phase HPLC (RP-HPLC) technique with a photo diode array (PDA) detector was developed by utilizing a C18 stationary phase column. The eluent comprised a mixture of acetonitrile and water with 0.1% (v/v) ortho-phosphoric acid. To establish the intrinsic stability of the ubrogepant pharmaceutical product, it was stress-tested under various degradation conditions, including water, alkaline, acid hydrolysis, photolytic, oxidative, and thermal. Flash chromatography was used to isolate the two major degradants, and the structures were determined using NMR (1H, 13C, distortionless enhancement by polarisation transfer-DEPT-135), IR, and LC–MS methods. Results The ubrogepant medication was relatively more degradable in alkaline and acidic conditions, and two unique degradation products were discovered. Based on spectroscopic and chromatographic evidence, it was conclusively demonstrated that these unique compounds were ubrogepant hydrolysis products. All degradation products were separated with a resolution greater than 2.0. The peak purity data showed that the ubrogepant peak in all of the stress samples examined was pure. Under all stress environments, ubrogepant achieved a minimum mass balance of 95%. The validated approach developed was sensitive enough to quantify ubrogepant degradation products at 0.03% of the ubrogepant test concentration. Conclusion The proposed method was found to be stability-indicating since it fits all of the regulatory authorities' typical requirements. This method is highly efficient for detecting and quantifying impurities in ubrogepant drug substances and drug products in QC laboratories. Highlights Two new degradation products of ubrogepant were successfully extracted and characterized using NMR, IR, and LC–MS spectroscopic methods. The proposed HPLC method can accurately quantify the degradation products of ubrogepant in pharmaceutical products and is sensitive enough to detect degradation products of ubrogepant as low as 0.17 µg/mL.

In vitro and in silico antileishmania activity of voriconazole (Vfend)

American Cutaneous Leishmaniasis (ACL) is a public health problem in 88 countries. The treatment of ATL is based on pentavalent antimony, which has several adverse effects. And through new alternatives for the treatment of leishmaniasis, the use of off-label medications appears. The objective of this work was to evaluate, through in vitro and in silico tests, the activity of voriconazole in tablet form as off-label against the promastigote forms of Leishmania amazonensis and Leishmania guyanensis. In the bioassay, species of Leishmania (L.) amazonensis and Leishmania (V.) guyanensis were used, cultivated in RPMI medium with 10% SFBi. The 50% inhibitory concentration (IC50) of voriconazole was evaluated by the inhibition of promastigotes exposed to voriconazole at concentrations of 6.25 to 200 µg.mL-1 diluted in culture medium and fluconazole at 25 to 400 µg.mL-1. In the experiment, parasites plus culture medium and pentamidine isethionate at 3 µg.mL-1 were used as controls for 24, 48 and 72 h in triplicate. The concentrations of voriconazole used in the test showed antileishmanial activity against promastigotes of both Leishmania species, with an IC50 of 5.34 µg.mL-1 for L. amazonensis and 5.66 µg.mL-1 for L. guyanensis. Therefore, the study showed that off-label voriconazole presented better results than fluconazole against Leishmania species, in addition to showing better enzymatic coupling of new targets.

An Innovative RP-HPLC Method for Simultaneous Estimation of Montelukast and Ebastine in Tablet Formulations: Development, Validation, and Stability Assessment

This study aimed to develop and validate an innovative reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of montelukast sodium (MNK) and ebastine (EBA) in tablet formulations. Utilizing a Shimadzu LC2010CHT system with a Phenomenex Luna C18 column, the mobile phase consisted of ammonium acetate buffer, acetonitrile, and methanol in a 12:55:33 ratio, with a flow rate of 1.0 mL/min and detection at 250 nm. Validation followed ICH guidelines, assessing linearity, accuracy, precision, robustness, and stability under various stress conditions. Both MNK and EBA showed excellent linearity within 16 to 24 μg/mL with correlation coefficients of 0.999. Accuracy was confirmed through recovery studies showing 98 to 102% mean recoveries. Precision was demonstrated with %RSD values below 2%. The method remained robust under slight variations in conditions, and stability studies indicated minimal degradation of both drugs. The developed RP-HPLC method proved rapid, precise, and robust for the simultaneous quantification of montelukast and ebastine in tablet formulations, demonstrating practicality and reliability for pharmaceutical quality control.

Formulation, Development and Characterization of Oral Jelly to Improve Therapeutic Effectiveness

The oral route is the most convenient and has great effectiveness in taking new chemical entities; hence it has improved patient acceptance. However, the main limitations associated with such formulations involve unpleasant or bitter taste as well as problems related to swallowing and reduced bioavailability of chemical entities. When it comes to children, the main limitation is they cannot safely swallow the medications in the form of tablets and capsules. But kids, even those without teeth, can swallow the jelly easily. As in the development of new dosage forms for every child, taste, color, smell, texture, and appearance are important factors in improving patient compliance. Children refuse to tolerate the same medication again, which becomes a big problem for parents trying to take the medication. An effective way to solve such types of problems involves the production of children’s friendly dosage formulations with attractive and eye catching taste, smell, color as well as texture. The most identical characteristic of oral jelly as dosage form is that it are easy to chew and dissolves rapidly in saliva so no water is required. Moreover, the good texture and appearance make it easy to attract patients as well as to improve patient compliance. Above all, it provides a soft and beautiful texture, causing no discomfort to patients.

Development and validation of stability indicating HPTLC method for simultaneous estimation of Dapagliflozin and Linagliptin

For the treatment of Type 2 Diabetes Mellitus, Dapagliflozin selectively inhibits the sodium-glucose co-transporter-2, while Linagliptin competitively and reversibly inhibits dipeptidyl peptidase-4 in a fixed dose combination (1:1). Dapagliflozin and Linagliptin estimation in bulk and tablet formulation was accomplished by the development and validation of a precise and accurate HPTLC method. The procedure used Toluene: Chloroform: Methanol: Triethylamine (7:2:1:0.2 v/v/v) as the mobile phase and HPTLC aluminum plates pre-coated with silica gel 60 F254 as the stationary phase used. Dapagliflozin and Linagliptin were determined to have Rf values of 0.23 and 0.40 correspondingly. At 224 nm, densitometric analysis was performed in the absorbance mode. For Dapagliflozin and Linagliptin 200–1200 ng/band were the linear ranges in which the procedure produced results. Forced degradation studies were performed on both Dapagliflozin and Linagliptin active pharmaceutical ingredients like acid hydrolysis, base hydrolysis, chemical oxidation, dry heat and photodegradation studies. Dapagliflozin and Linagliptin are susceptible to acid hydrolysis, base hydrolysis, chemical oxidation while both the chemical substances are stable to dry heat and photolytic studies.

Formulation and Evaluation of Herbal Tablets from the Shimshin-6 Prescription and Its Effect on Postpartum Involution in Rats

The Shimshin-6 prescription has been used to treat female patients for blood clots, back and waist pain, and menstrual cramps. It is intended to support the recovery of the uterus after both childbirth and abortion. The purpose of this study is to create a tablet form of the Shimshin-6 formula and examine its effects on the recovery of the uterus after childbirth. The granules were developed using wet granulation, and the tablets were made using a direct compression method. Our test product in tablet form was manufactured following the quality parameters specified in the Mongolian National Pharmacopoeia. Shimshin-3 tablet was considered the best formulation; it used 5% cane sugar as a binder. In this study, Shimshin-6 treatment significantly reduced the uterus index and blood estrogen levels compared to the control group showing no difference in progesterone concentration. We found that Shimshin-6 decreased Tumor Necrosis Factor (TNFα) and regulated growth factors in postpartum rats. Shimshin-6 also regulated postpartum uterine recovery, as indicated by histological analysis. Our results showed the infiltration of inflammatory cell and hemorrhagic changes in the uterine wall. In conclusion, the formulation and evaluation of herbal tablets were satisfactory, and it has been found to enhance uterine recovery postpartum in rats.

Development and Validation of HPTLC for the Determination of Gefitinib HCl in Tablet Dosage Form

A simple, high-performance thin-layer chromatography (HPTLC) method of gefitinib HCl in pharmaceutical formulation was developed. Separation was done on TLC aluminum plates precoated by silica gel 60GF254 (20 × 20 cm) with 200 μm layer depth. With UV detection set to 254nm, chromatography was conceded out by the mobile phase of dichloromethane and methanol (9:1, v/v). Linearity was found to range of 50 to 300 ng/spot and, the correlation coefficient was found to be 0.99 and the Rf value was found to be 0.46. The system’s suitability was considered to ascertain the performance of ascertaining quality performance of the developed chromatographic method. The method’s accuracy, precision, and specificity were all verified against the International Council of Harmonization (ICH) standards. Application of the approach to the determination of gefitinib in tablet form was successful.

Isolation and Characterization of Irvingia gabonensis Seed Contents and the Tableting Properties of its Gum Component

This experimental work was designed to isolate, purify and estimate the fatty acids contents of Irvingia gabonensis seeds (IGS) and to evaluate the tableting properties of the gum constituent of the seed in metformin tablet. A known amount of the IGS was crushed and dispersed in purified water at a temperature of 80oC, Ethanol (90 %) was added, filtered and dried at 40oC. The fatty acid components were recovered using petroleum ether, while the gum was further purified with ethanol (90%). The fatty acid contents obtained were analyzed using an Agilent G1701 GC/MSD system. The gum content was evaluated using parameters such as: flow rate, angle of repose, bulk and tapped density and Carr’s index. The gum was granulated with other excipients and metformin powder dried at 40oC. The granules were evaluated as was done for the gum and tablet compression done at 2.0 KN on a single punch tablet machine fitted with 12.5 mm diameter die size. The GC-MS revealed bioactive compounds mainly fatty acids– lauric acid (36.82%), myristic acid (31.52%), benzyl dodecanoate (9.06%) and palmitic acid (4.03%), n-decanoic acid, 1-(hydroxymethyl)-1,2-ethanediyl ester, tetradecanoic acid, 2-hydroxy-1,3-propanediyl ester, etc. The granule size distribution revealed size and compactness in the following order: Acacia gum &gt; IGS-gum &gt; Gelatin, and average granule size for the batches were found to be 500 μm. Evaluation of metformin tablets gave the following results: crushing strength, friability, and disintegration time for B7 and B8 (7.5 and 10 %w/v IGS-gum as binder) as 58 and 68 N, 1.03% and 1.01%, 20.00 and 26.00 min., respectively. B3and B4 (7.5 and 10 %w/v acacia were shown as gum as binder) 44 and 48 N, 1.10 and 1.03%, 20.00 and 23.50 min., respectively. It can be concluded that at 7.5 and 10 %w/v, IGS-gum proved to be a better binder than acacia in metformin tablets formulation. Dhaka Univ. J. Pharm. Sci. 23(1): 53-62, 2024 (June)

Simultaneous RP-HPLC Estimation, Validation and Stability Indicating Assay of Two-Component Tablet Formulation Containing Grazoprevir and Pibrentasvir

The determination of a two-component tablet formulation containing grazoprevir and pibrentasvir for method development and validation has been done using the reverse-phase high-performance liquid chromatography (RP-HPLC) method as per International Council of Harmonization (ICH) guidelines. Analytical grade acetonitrile and 0.01 N of potassium dihydrogen phosphate buffer were used as mobile phase while Kromasil C18 column was opted for separation. In order to elute the analyte a flow rate of 1-mL/min having 260 nm λ has been maintained. An RT of 2.909 and 2.358 minutes while linearity concentration range from 25 to 150 μg/mL and 10 to 60 μg/mL was obtained for grazoprevir and pibrentasvir, respectively, with 4.4 resolution. Both had a high correlation coefficient of 0.999. The limit of quantification was 0.24 and 0.09 μg/mL, while the detection limit at 0.72 and 0.27 μg/mL was noticed for grazoprevir and pibrentasvir, respectively. For grazoprevir and pibrentasvir, the regression equation was determined to be y = 16332x + 5313.1 and y = 17261x + 601.95, correspondingly

Comparative study of UV spectroscopy, RP-HPLC and HPTLC methods for quantification of antiviral drug lamivudine in tablet formulation

BackgroundIn the current study, estimation of lamivudine (LMU) by UV spectroscopy, reverse-phase HPLC (RP-HPLC) and HPTLC methods in tablet formulation was developed, and comparative studies between the methods were investigated by analytical results and statistical test analysis of variance (ANOVA) to find out best method. In the UV spectral method, LMU was quantified at 271 nm absorption maxima using methanol as the solvent. In the RP-HPLC method, the Shimadzu C18 column (250 mm × 4.6 mm i.d., 5 µm particle size) was employed for chromatographic separation. The mobile phase used consists of methanol: water (70:30 v/v) in an isocratic mode with a 1.0 mL/min flow rate. In the HPTLC method, the chromatogram was developed on a pre-coated plate of silica gel 60 F254 with a mobile phase composition of chloroform: methanol (8:2 v/v). The quantification was performed at an absorbance mode of 271 nm by densitometry. The methods were validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1). The degradation conditions were employed as per ICH guidelines Q1A(R2) and Q1B which include acid, alkaline, neutral, thermal and photostability to determine the intrinsic stability of the drug in varied environmental conditions.ResultsLMU absorption maxima was found to be 271 nm. The retention time of LMU was 3.125 min, and the total analysis time was 5 min. The Rf value of LMU was 0.49–0.62. The methods were linear within 2–12 μg/mL range. The correlation coefficient (r2) for UV, HPLC and HPTLC was 0.9980, 0.9993 and 0.9988, and percent recoveries were calculated as 98.40–100.52%, 99.27–101.18% and 98.01–100.30%, respectively, with percentage relative standard deviation (RSD) less than 2% showing that methods were precise and accurate.ConclusionDeveloped UV, RP-HPLC and HPTLC methods are free from intervention caused by excipients present in tablets and thus can be used for regular quantitative analysis of LMU in tablet formulation. Based on analytical results and statistical tests, ANOVA, it is inferred that the HPLC method is best for LMU quantification tablet formulation due to its high reproducibility, good retention time and sensitivity; it has a higher percent recovery and has less analysis time, i.e., 5 min. The degradation peaks were well separated from the LMU peak indicating stability of the HPLC method.

Development of a Robust and Reliable RP-HPLC Method for the Estimation of Finerenone in Tablet Dosage Form

An advanced analytical method was explored, specifically tailored for estimating finerenone, a vital drug found in tablet formulations intended to reduce the risk of chronic kidney disease in patients with type-2 diabetes. This sophisticated technique employs an Inertsil ODS 3V C18 column (5 μm particle size x 250 x 4.6 mm) for precise separation of analyte. The mobile phase consists of an ammonium dihydrogen phosphate buffer (pH 4.5) and acetonitrile (60:40), which is a carefully balanced mixture that flows consistently at 1.0 mL/min. UV detection is achieved at a wavelength of 238 nm. Finerenone’s characteristics are unveiled with a brief retention time of 4.06 minutes, highlighting the efficiency of the method. The method demonstrates linearity within the concentration range of 2.5 to 15 μg/mL, offering a comprehensive scope for accurate analysis. This robust reversed-phase high-performance liquid chromatography (RP-HPLC) method undergoes thorough validation following International Council for Harmonisation (ICH) guidelines, ensuring its reliability. Notably, the accuracy is impressive, with a mean recovery falling comfortably within the acceptable range of 99.76 to 101.09%. In summary, our analytical approach stands out for its simplicity, precision, sensitivity, rapidity, and robustness in estimating finerenone in tablet formulations.

Formulation and Evaluation of Tablets Using the Solvent Evaporation Method to Increase the Solubility of Lansoprazole

The inability to determine sufficient and repeatable bioavailability and/or desirable pharmacokinetic features in humans is one of the biggest obstacles to the oral administration of new medicines. The solubility and absorption of a medicine determine its bioavailability, which in turn determines its therapeutic efficacy. Achieving the target drug concentration in the systemic circulation and ensuring drug biological activity in humans are both affected by solubility. A stomach ulcer has the potential to rip through the stomach lining, the initial section of the small intestine, and possibly even the lower esophagus. Distinct ulcers form in different parts of the intestines; one forms in the duodenum and one in the stomach. Duodenal ulcers are most commonly characterized by upper abdominal pain at night that subsides after eating. Eating might exacerbate the discomfort from a stomach ulcer. Preparing and assessing the pills will yield optimal outcomes. The active component content is 99.90%, as is the active ingredient release rate. Compared to other formulations, solid dispersion tablets performed better in in-vitro tests (98.85%). The optimized formulation (lansoprazole solid dispersion tablets) outperformed the labeled formulation (conventional lansoprazole tablet) in terms of drug-releasing capacity within 6 hours, outperforming both formulations.

Formulation Development and Evaluation of Ticagrelor Oral Dispersible Tablets by Using Co-processed Superdisintegrants

Ticagrelor is a contemporary anti-platelet drug that inhibits the aggregation of platelets by blocking the adenosine phosphate (ADP) receptors of the subtype P2Y12; generally utilized in patients who have a previous history of myocardial infarction or with acute coronary syndrome to prevent occurring of myocardial infarction, cardiovascular death and stroke in future. This study focuses on the development of formulation development &amp; assessment of an oral dispersible tablet of ticagrelor, a Biopharmaceutical Classification System (BCS) class 4 drug, by using the co-processed superdisintegrants to enhance drug dissolution and bioavailability. Wet granules with different concentrations of co-processed superdisintegrants developed the tablets. This study includes seven formulations that were formulated using the different selected excipients. The various batches were assessed for physical characteristics, disintegration, dissolution studies, hardness and friability. In-vitro dissolution investigations were conducted for formulations. S1 to S7 at time points 5, 15 and 30 minutes. According to the results of the formulation S7 was discovered to be the optimum formulation, as shown 102.89% drug release at 5 minutes and a disintegration time of 16 seconds. Thus, it appears that S7 is the most suitable formulation of ticagrelor oral dispersible tablet in order for enhanced bioavailability.

Formulation and Evaluation of Immediate Release Tablets of Antimalarial Drug Hydroxychloroquine

The goal of the study was to develop and evaluate an immediate-release antimalarial tablet formulation for the effective management of malaria, an antimalarial drug as an active pharmaceutical ingredient using excipients. Appropriate pharmaceutical products and evaluate their properties in relation to the innovative product. The study was to develop an antimalarial formulation with in-vitro solubility properties equivalent to or better than the improved formulation. Therefore, an orally administered immediate-release tablet with a robust and reproducible formulation technique was developed. According to the study, the number of F3 definitions decreased the most and F8 had the most important medicinal properties. At 20 minutes, F4 appeared to lead the first high decay rate (98. 56%), followed closely by F5 (93.48%). The expansion of F1, F2 and F3 shows high decay rates at this time. Based on this information, one can analyze and compare the decay profiles of unmistakable definitions. Things such as composition, excipients used, and manufacturing geometry can influence degradation behavior, and this information may be necessary to optimize concentrations of substances of interest for drug delivery. It is then concluded that the definition number F5 may be an optimized detail.

Formulation, Development and In-vitro Characterization of Modified Release Tablets of Curcumin

Objective: The current study set out to design and test a cost-effective system for developing modified-release tablets of curcumin in an effort to increase the duration of drug release. Because curcumin has a shorter elimination half-life, reducing the frequency of doses can increase its bioavailability. Methods: For improved drug retardation in the stomach environment, modified-release tablets were made utilizing the wet granulation method with various grades of high-potassium chloride (HPC) as the extended-release matrix-forming agent and katira gum as the viscosity-modifying agent. Combining the use of HPC and katira gum slows the drug’s release in the stomach. The sustained-release tablets had the highest rate of medication release for up to 24 hours with almost no stomach absorption. The medication and excipients did not interact, according to the fourier-transform infrared spectroscopy (FTIR) spectra. There was no evidence of drug-excipient incompatibility, according to differential scanning calorimetry (DSC) tests. Optimal formulation batch F2 modified release tablets showed no outward signs of deterioration after three months of storage, according to stability analysis. Further evidence that F2 was steady is the lack of variation in drug content and percentage of drug release. Conclusion: This study accomplished its stated goal of creating a modified-release tablet formulation that is both cost-effective and does not make use of coating technology.

Formulation Optimization and Preparation of Amlodipine and Telmisartan Double-layer Tablets (5/40Mg) using Wet Granulation Method

The two-layer tablet of amlodipine and telmisartan is an effective strategy to manage hypertension disease through a combination of various treatment mechanisms. However, the spray-drying method is currently used to prepare telmisartan tablets due to its extremely low solubility, which requires sophisticated equipment. In this study, wet granulation was applied to fabricate this two-layer tablet. Furthermore, design of experiments were deployed to design and optimize the formulation in order to obtain an in-vitro equivalence with the reference drug. As a result, a formulation of the two-layer table using the wet granulation method was successfully developed and optimized. The obtained tablet showed an in-vitro equivalence with the reference drug (with f2 superior to 50 for both amlodipine and telmisartan). Furthermore, the obtained tablet also met a set of in-house standards, including appearance, identification, assay, and dissolution rate. This study provided not a novel but effective and simple method of fabrication for amlodipine-telmisartan tablets using wet granulation. Furthermore, the obtained results also highlighted the significant contribution of a well-established design of experiments in the development of a complex tablet formulation.

A REVIEW ON FORMULATION AND EVALUATION OF TABLETS

A REVIEW ON FORMULATION AND EVALUATION OF TABLETS

A data-driven approach utilizing a raw material database and machine learning tools to predict the disintegration time of orally fast-disintegrating tablet formulations

Orally fast-disintegrating tablets (OFDTs) have seen a significant increase in popularity over the past decade, becoming a rapidly expanding sector in the pharmaceutical market. The aim of the current study is to use machine learning (ML) methods to predict the disintegration time (DT) of OFDTs. In this study, we have developed seven ML models using the TPOT AutoML platform to predict the DT of OFDTs. These models include the decision tree regressor (DTR), gradient boost regressor (GBR), random forest regressor (RFR), extra tree regressor (ETR), least absolute shrinkage and selection operator (LASSO), support vector machine (SVM), and deep learning (DL). The results indicate that ML methods are effective in predicting the DT, especially with ETR. However, after fine-tuning the deep neural network with a 10-point cross-validation scheme, the DL model showed superior performance with an NRMSE of 6.2% and an R2 of 0.79. The key factors influencing the DT of OFDTs were identified using the SHAP method.

QOL-37. THE CREATION OF A PLAY PREPARATION CLINIC FOR CHILDREN WITH CENTRAL NERVOUS SYSTEM TUMOURS TO REGAIN CONTROL ONCE MORE

Abstract Targeted therapies are becoming more readily available for children with Central Nervous System (CNS) tumours, not only for early phase but also late phase trials. With this knowledge, we have created a play preparation clinic whereby all children with a CNS tumour diagnosis are invited to attend. Initially the play preparation clinic was solely a programme to train children to take tablets using a technique created at The Great North Children’s Hospital called ‘Kidzmeds’. On average children are successful in achieving the ‘Kidzmeds’ technique within ten minutes so we were able to expand the programme and incorporate two other areas of play preparation. Firstly, we have been able to include play preparation for children undergoing procedures without sedation or general anaesthesia such as MRI scans and lumbar punctures. Secondly, we have been able to use play preparation to teach children how to achieve cannulation or blood taking using a specific technique we have called the ‘GNCH way’. Our aim is that children leave our hospital having a positive experience and regain control and choice in how procedures take place, feeling they have ownership of their bodies. There is an added incentive of cost saving for our hospital, for example converting medication from liquid to tablet form. Forty-eight children have took part in the clinic so far. Every child has been able to achieve two of the play preparation techniques we offer and eighty-three percent of children have been successful in achieving all three. The youngest child in achieving all three play preparation techniques has been four years old. All forty-eight children continue to be successful in their achievements. Within our service, the feedback from children and families have been overwhelmingly positive and our hope is that other hospitals across the world can benefit from our experience.