Pharmaceutical and Biomedical Sciences Journal Volume 6.
, 2024, 118-123
________________________________________________________________
A retrospective descriptive cross-sectional study of Oral Dosage Form Administered in The Form of Suspension to ICU Patients at Hospital X Nelly Suryani1*.
Vidia Arliani Anwar2.
Yardi Saibi1.
Estu Mahanani Dhilasari1.
Sabrina Dahlizar1.
Ofa Suzanti Betha1.
Ismiarni Komala1 .
Afifah Nurnishrina Azzahra1 1Departement of Pharmacy.
Faculty of Health and Sciences.
Syarif Hidayatullah State Islamic University.
Jakarta.
Indonesia 2Stikes IKIFA East Jakarta.
Indonesia *corresponding author: nelly.
suryani@uinjkt.
Received: 17 September 2024.
Accepted: 18 December 2024 Abstract: Patients in the intensive care unit were often very sick and had lost consciousness.
Because they had trouble swallowing, individuals with reduced awareness frequently depended on enteral tubes (NGT) for their daily medical and nutritional requirements.
Since not all medications were accessible in parenteral forms, patients who relied on enteral tubes often had issues, including drug stability.
Many problems arose in clinical usage when the medication was crushed or suspended and put into the NGT, including drug obstruction in the enteral tube and a reduction in drug stability as a result of the dose form being altered, making the drug unstable.
Thus, this study aimed to ascertain the stability of oral suspension medications given to intensive care unit patients.
The medical records of intensive care unit patients who had received oral medication therapy at X Hospital in Jakarta were examined retrospectively using a cross-sectional, descriptive approach.
According to the statistics, coated tablets accounted for 68% of the most frequently used oral medication preparations.
It was highly likely that crushing the coated tablets and administering them via NGT had resulted in tube obstruction.
Additionally, 26% of the medications used had exhibited hygroscopic qualities, and several had been readily hydrolyzed.
Based on these findings, it was concluded that oral medications, particularly crushed-coated tablets, could negatively affect drug Active substances with hygroscopic properties and those prone to hydrolysis were also identified as potential contributors to instability.
Keywords: Enteral Tube.
Hygroscopic.
ICU.
Oral Medicine.
Stability DOI: 10.
15408/pbsj.
INTRODUCTION
cases, nasogastric tubes could become clogged The Intensive Care Unit (ICU) was a part of the hospital that served patients with acute or chronic illnesses requiring immediate intervention that could not be provided in general care rooms (Ananta and Fitri, 2.
During the swallowing process, most ICU Patients in this condition typically relied on a nasogastric tube, also known as an NGT.
The NGT was used to provide nutrition and daily care (Sigmon and An, 2.
(Kunieda et al.
, 2.
This could impact the stability of medications used in ICU patients and was a major risk factor (Rahmawati et al.
, 2.
If a product retained the same characteristics and quality as when it was manufactured and could be stored within certain limits, it was referred to as stability.
The stability of active ingredients, the manufacturing process of dosage forms, packaging methods, and environmental factors such as temperature, or formulation factors like pH, solubility in water, and particle size were some factors that could affect the Oral solid medications administered via an NGT were crushed or triturated with 10-20 milliliters of water using a mortar and pestle.
Tube blockage during administration was one of the many issues associated with the clinical use of this technique.
In 6-45% of stability of pharmaceutical preparations.
The case of drug instability in intravenous catheters was typically caused by pH precipitation (Hanifah, 2.
When a drug was prepared in solution form, it was important 119 Pharmaceutical and Biomedical Sciences Journal, 2024.
Vol.
Suryani et al.
to determine the ideal pH of the preparation, as the The study findings were presented in narrative or solution's pH significantly impacted its stability illustrative form.
(Banker and Rhodes, 2.
Inclusion Criteria The study conducted by Bernardus et al.
found that 100% of compounded drugs underwent physical Complete changes due to their hygroscopic or moisture- .
edical record number, gender, and ag.
retaining properties, which led to alterations in the that were clearly legible.
stability of the drugs.
In the study conducted by The research subjects were medical record Thong et al.
, it was found that an assessment data of patients who received oral therapy in of medication loss among 24 commercially available suspension form in the ICU of RS Pelabuhan medication-crushing devices revealed that medication Jakarta.
loss, without rinsing, ranged from 1.
9% to 13.
depending on the crushing device.
All devices, except Patients who received therapy with Ou 5 oral for six, resulted in significant drug loss.
Exclusion Criteria In addition to pH, drugs containing ester and amide Medical records that were incomplete, groups often underwent degradation pathways.
Drug unclear, or illegible and could not be instability could lead to decreased or lost efficacy, conversion of the drug into a toxic form, or changes in the appearance of the preparation .
uch as color, odor, taste, and consistenc.
, which could be detrimental to the user.
x This drug instability had the Patients who received treatments in forms other than oral preparations.
Patients who received therapy with O 5 oral potential to endanger the patient's condition.
As a result, it delayed the therapeutic process and 2 Study Subjects increased therapy costs.
Research related to drug The sample for this study comprised all medical stability and compatibility remained very limited.
records of ICU patients who were administered solid This study aimed to ascertain the stability of oral oral medication at Hospital X Jakarta from July to suspension medications given to intensive care unit December 2021.
A total of 34 patients were included The medical records of intensive care unit in the study, consisting of 20 men and 14 women.
patients undergoing oral medication therapy at X secondary data were used, no sampling technique was Hospital in Jakarta were reviewed retrospectively applied in this study.
using a descriptive, cross-sectional method.
3 Data Analysis MATERIALS AND METHOD To determine the prevalence of incompatibility and 1 Study Design stability issues with oral preparations in the ICU.
A retrospective descriptive cross-sectional method univariate analysis was conducted using Microsoft was used in this study.
Medical records of ICU Excel 2010.
patients at Hospital X in Jakarta who received oral medication as part of their therapy were reviewed.
120 Pharmaceutical and Biomedical Sciences Journal, 2024.
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RESULTS AND DISCUSSION
Suryani et al.
whole, they should not have been chewed, crushed, split, or broken, as per the IAI guidelines .
1 Patient Characteristics Table 2 presents this data.
There were 34 ICU patients, including 20 male and 14 female patients.
The largest age group consisted of 17 patients over 65, followed by eight patients aged 56 to 65.
According to a 2011 study by Vera at Immanuel Hospital Bandung, the age group 60-69 years accounted for 46% of the population, and those over 80 years represented 18%.
This was considered References Martindale Edition.
Indonesian Pharmacopoeia VI Edition.
Handbook on Injectable Drugs 17th Ed, and journal articles were used to process data on the physicochemical properties and stability of drugs administered to ICU patients at Hospital X Jakarta.
a risk factor due to the association between age and the aging process, which led to decreased organ function in elderly patients.
The mortality rate for critically ill patients increased with age (Root et al.
The percentage of patient characteristics is shown in Table 1.
Table 1.
Characteristics of ICU Patients Based on Gender and Age for the Period July Ae December 2021 Characteristics Number of Medical Records .
Percentage (%) Gender
Male
Female Age
>65
2 Types of Oral Solid Dosage Forms.
The results showed that ICU patients at Hospital X Jakarta commonly used film-coated and entericcoated tablets, with 15 frequently used medications.
Table 2.
Frequency Distribution of Oral Solid Drugs Based on Preparation Type
Name of Drugs Film Coated Tablets ISDN
Bisoprolol
Simvastatin
KSR
Amlodipine Furosemide Atorvastatin
Ethambutol
Isoniazid
Azithromycin
Euphilin
Metformin
Cefixime Spironolactone Cetirizine Enteric Coated Tablets Aspirin
Sugar Coated Tablets Bicnat
Uncoated Tablets Candesartan Paracetamol
Alprazolam
Digoxin
Glimepiride Capsule N-Acetyl Cysteine Caplet
BECOM C
Ramipril Total Frequency Percentage % These included isosorbide dinitrate for 21 patients .
96%), bisoprolol for 17 patients .
49%), and The hygroscopic properties of drugs presented in simvastatin for 10 patients .
17%).
Table 3 were referenced to estimate potential The data showed that some drugs were The most commonly used enteric-coated tablet was Hygroscopicity is the ability of a aspirin, administered to 16 patients .
%).
This could substance to absorb moisture from its environment.
lead to drug instability due to the variety of coated Evaluating the hygroscopicity of pharmaceutical tablet formulations administered through enteral solids was crucial, as absorbed moisture could impact If these drugs were intended to be swallowed pharmaceutical products' physical and chemical (Allwood Kearney, 121 Pharmaceutical and Biomedical Sciences Journal, 2024.
Vol.
Suryani et al.
(Gayatricitraningtyas and Abidjuli, 2.
(Benardus, these two drugs were combined and administered through an enteral tube, drug instability could occur, causing the medication to become sticky and adhere Hygroscopic drugs should have been stored in tightly to the tube, leading to blockages in the enteral tube sealed containers to slow the degradation of their (Allada et al.
, 2.
powders (Allada et al.
, 2.
Hygroscopic or moisture-sensitive drugs, such as salts like HCl.
HBr, and maleate, complicated tablet manufacturing (Allada et al.
, 2.
The hygroscopic nature of an active pharmaceutical ingredient affected the stability of the drug itself and impacted the moisture level of other drugs when combined (Allada et al.
, 2.
Moisture in powders led to microbial growth reduced ingredients, including color, odor, and clumping upon mixing (Allada et al.
, 2.
Table 4.
Drugs Not Available in Parenteral Preparations No.
Name of Drugs Bisoprolol Aspilet Simvastatin KSR (Potassium chlorid.
Amlodipine Candesartan Atorvastatin Becom C Alprazolam Rapimpril Isoniazid Ethambutol Metformin Cefixime Glimepiride Spironolactone Cetrizin Table 3.
Hygroscopic Properties of Drugs 3 Solid Oral Dosage Forms Total Name of Drugs ISDN (Isosorbid Dinitra.
Aspirin
Simvastatin
KSR
Candesartan Furosemide Becom C Ethambutol Ramipril Digoxin Metformin Glimepiride Cefixime Spironolactone Paracetamol Cetrizin Alprazolam Bisoprolol Amlodipine N-Acetyl cysteine Isoniazid Bicnate Azithromycin Atorvastatin Euphilin Instability percentage Number of Prescriptions Containing Drugs Hygroscopic 59,26% Data regarding medications that were unavailable in parenteral forms was presented in Table 4.
Out of the 25 drugs surveyed, 17 of them were not accessible orally because these medications were transformed into suspensions administered via nasogastric tubes (NGT) before being given to patients.
Consequently, researchers were more interested in understanding how the stability of these drugs changed after being converted into suspensions.
According to Ruzikova .
, crushing or grinding coated tablet medications were not recommended as they altered the drug's stability.
Crushing solid oral dosage forms impacted the stability of the active pharmaceutical ingredient.
If tablets were broken to remove the enteric coating that protected the drug from the acidic gastric environment, the degradation Instability also occurred when certain drugs were co- of the drug in vivo increased, resulting in a minimal prescribed, such as metformin and ethambutol.
Both amount of active drug available to produce the salts had hygroscopic properties, meaning they could desired clinical effect (Root et al.
, 2.
absorb and retain moisture at various temperatures and humidity levels (Allada et al.
, 2.
Thus, when 122 Pharmaceutical and Biomedical Sciences Journal, 2024.
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Suryani et al.
Crushing enteric-coated tablets and administering been tailored to the needs of local healthcare them via enteral feeding tubes was likely to cause The aspect of bioequivalence of drugs had tube blockages.
This occurred because, prior to to be considered when converting drugs to another inserting enteric-coated tablets through the enteral formulation, as it could lead to changes in efficacy feeding tube, the enteric coating had to be broken or and safety.
Variations in the amount of drug that As a result, the drug was likely to degrade reached systemic circulation due to changes in drug in the stomach.
Thus, the amount of drug that could formulation could impact efficacy and the likelihood be absorbed decreased, and patients needed to be of side effects, particularly for drugs with a narrow monitored regularly (Valentovic, 2.
therapeutic index, such as digoxin and theophylline (Root et al.
, 2.
One example of a prodrug, simvastatin, was administered in an inactive lactone form and was CONCLUSION processed by the liver into the beta-hydroxy acid The study showed that the most commonly used oral drug preparations were coated tablets, accounting for Subsequently, the active plasma inhibited HMG-CoA Crushing coated tablets and administering them reductase .
ydroxymethylglutaric acid coenzyme A through NGT had a high likelihood of causing tube Additionally, 59.
26% of the drugs used Hydrolysis of simvastatin to simvastatin acid could exhibited hygroscopic properties, and several were increase plasma concentration, affecting simvastatin's prone to hydrolysis.
The findings concluded that solid efficacy and adverse reactions (Basusarkar, 2.
oral drugs, particularly crushed-coated tablets, could Simvastatin is also hydrolyzed at basic pH.
negatively affect drug stability, and active drug (Sinaga, (Li substances with hygroscopic and easily hydrolyzed Moreover, spironolactone was easily hydrolyzed due properties had the potential to cause instability.
to its lactone ring .
yclic este.
and thioester group.
The degradation resulted from hydrolysis of the thioacetate group to produce 7-thiospironolactone .
s an intermediat.
, followed by S-methylation to generate 7-thiomethylspironolactone.
The lactone 7-thiomethylspironolactone hydrolyzed to produce canrenone.
(WHO, 2.
The effect of this hydrolyzed drug caused the drug to degrade in the stomach, leading to a decrease in drug levels in the body (Root et al.
, 2.
By changing the dosage form from tablets to suspensions, the stability of the drug changed, especially for coated tablet
One aspect that had to be considered when administering medications through enteral tubes was the type of drug selected, which should always have REFERENCES