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Renata Amalia Azizah; Callista Luna Sadi Qova Gunawan; Shelfia Putri Chantika; Axelando Carlos Febiyano; Margaret Rianti Martalina

Journal of Educational Innovation and Public Health 2026 Pusat Riset dan Inovasi Nasional

The optimal therapeutic impact of local vaginal drug delivery systems is strongly influenced by the physical characteristics balance of Solid Vaginal Suppositories. A comprehensive review regarding the comparison of mechanical profiles, specifically melting time and crushing strength parameters, from various base classifications constitutes the primary objective of this literature research. The implementation of a Literature Review study design was executed through the extraction of empirical data from twelve experimental journals published within the last ten years. Excessively rapid phase transformation characteristics at physiological basal temperatures and low compression resistance were consistently demonstrated by lipophilic bases such as Oleum Cacao. The risk of structural deformation during the distribution process is highly susceptible to unmodified lipid preparations. High surface elasticity accompanied by a delay in molecular hydration duration reaching 120 minutes was recorded in the utilization of Glycerinated Gelatin Base. Structural rigidity exceeding 4 kgF and disintegration time efficiency under 60 minutes were optimally demonstrated by Polyethylene Glycol (PEG) Base. An enhancement in mechanical resistance against external shocks during the storage period is offered by the thorough modification of the synthetic polymer ratios. Therefore, the determination of the PEG base as the most optimal material is recommended to maintain the quality stability of pharmaceutical products. Compendial regulation standards regarding the physical strength testing of pharmaceutical preparations must be obeyed by every institution to ensure long-term treatment effectiveness. Thus, the alignment between active substance release duration and physical preparation endurance can be realized for absolute patient comfort.

Fitri Kurniasari; Jena Hayu Widyasti; Ismi Puspitasari; Carolina Eka Waty

Ekspresi : Publikasi Kegiatan Pengabdian Indonesia 2026 Asosiasi Seni Desain dan Komunikasi Visual Indonesia

Community service with the theme of Expired Date (ED) and Beyond Use Date (BUD) aims to improve knowledge and understanding of proper medication storage as an effort to enhance the health of the Gagak Sipat community. Knowledge about medication usage limits and checking product expiration dates educates the public to be more cautious and to avoid health risks that may arise from consuming products that have exceeded their usage period or have expired. The use of medicines beyond their ED and BUD indicates that the drugs may have experienced reduced stability related to storage conditions. Decreased stability of pharmaceutical preparations can affect their physical quality, which in turn impacts the effectiveness and safety of the medication. The educational method used in this program included lectures accompanied by the distribution of leaflets, followed by practical simulations on checking ED and calculating BUD for various dosage forms. The results of this educational activity showed that community members were able to determine the ED and BUD for several pharmaceutical preparations such as tablets, powders, capsules, syrups, eye drops, ear drops, and others. The community in Gagak Sipat village gained an understanding of the risks associated with using medications beyond the BUD, including reduced effectiveness, the risk of microbial contamination, and potentially harmful chemical reactions. It was emphasized that some medications that are expired or used beyond their BUD can pose more serious health risks, especially when used to treat severe diseases.

Muhammad Fadhli; M. Chaidir Hafidz; Nor Latifah

Jurnal Riset Ilmu Farmasi dan Kesehatan 2025 Asosiasi Riset Ilmu Kesehatan Indonesia

Stability testing is an important step in the development of pharmaceutical products. This testing must be conducted before the product is manufactured, whether on an industrial or non-industrial scale. Currently, liquid formulations are experiencing rapid development, one of which is suspension. Suspension itself is a liquid formulation that contains undissolved solid particles dispersed in the liquid phase. To assess the stability of suspension, various evaluations are performed such as organoleptic tests, sedimentation volume, redispersion, density, viscosity, particle size distribution, and pH measurement. Based on several studies, temperature is known to affect the stability of drugs, especially in suspension formulations. A study related to diclofenac suspension showed that at a temperature of 4°C, its stability reaches 96.3%, while at temperatures of 40°C and 60°C, there is a significant reduction in content, amounting to 89.58% and 85.17% respectively. Meanwhile, research on folic acid suspension revealed that the drug remains stable at temperatures of 4°C and 25°C, although on day 90 there was an increase in pH. Another study on cefuroxime axetil suspension showed that at a temperature of 20°C, its concentration was 87.68%, while at 5°C, it was higher at 92.35%. This research underscores the importance of considering temperature in the storage and formulation of pharmaceutical suspensions to maintain their effectiveness and stability.

Ghina Faiha; Hana Salma Cantika; Nor Latifah

Jurnal Riset Ilmu Farmasi dan Kesehatan 2025 Asosiasi Riset Ilmu Kesehatan Indonesia

Packaging plays an important role in maintaining the quality, stability, and effectiveness of medicines, both in the form of pharmaceutical preparations and herbal products. This review article aims to analyze the role of primary and secondary packaging materials through literature studies from various relevant journals. The method used was a literature review of four selected national and international journals that discussed the influence of packaging on product stability, information effectiveness, and product image in the eyes of consumers. The results of the study show that primary packaging functions to protect products directly from environmental influences, while secondary packaging functions in distribution, storage, and strengthening visual and branding aspects. Innovations such as the use of adsorbent plastics and visual redesign have been proven to increase stability and consumer confidence in the product. It can be concluded that packaging is a crucial aspect that not only maintains the physical-chemical quality of the product, but also shapes consumer perception and compliance.

Nabila Sativa; Nailia Nur Isma Sumarno; Nor Latifah

Jurnal Riset Ilmu Farmasi dan Kesehatan 2025 Asosiasi Riset Ilmu Kesehatan Indonesia

Pharmaceutical packaging serves not only as a means of protecting the product but also as a source of information and quality assurance for consumers. However, various studies indicate that packaging defects remain a significant issue in the pharmaceutical industry. This article is a literature review that examines several studies related to the analysis of the causes of packaging defects in pharmaceutical preparations. Based on the review of multiple scientific journals, it was found that packaging defects are generally caused by a combination of technical and non-technical factors, such as machine failure, operator error, inappropriate raw material specifications, and insufficient quality control.

Fitria Dwi Alvianingrum; Musa Fitri Fathkiya

Jurnal Riset Ilmu Farmasi dan Kesehatan 2025 Asosiasi Riset Ilmu Kesehatan Indonesia

Pharmaceutical services are carried out to achieve definite results in improving the quality of life of patients in the form of direct and resposibels services related to pharmaceutical preparations. In implementing pharmaceutical services, health centers already have a standard that is used as a guideline in its implementation. The consequences of implementing pharmaceutical services that do not comply with standards are medication errors and inappropriate use of drugs, there are expired drugs and overlapping budgets. The purpose of this study was to analyze the implementation of pharmaceutical service standards in health centers, BMHP and clinical pharmacy services based on PMK No. 74 of 2016 at the Paduraksa Health Center, Pemalang District. This study is a non-experimental study with a descriptive design that will provide an analytical description of the implementation of pharmaceutical service standards at the Paduraksa Health Center, Pemalang District based on the guidelines in the Minister of Health Regulation Number 74 of 2016. The population and sample in this study were all pharmaceutical personnel who were responsible for managing pharmaceutical service standards at the Paduraksa Health Center, by conducting interviews in the form of questions and answers by giving questions verbally to pharmacists or pharmaceutical personnel at the Paduraksa Health Center, Pemalang Regency. The data in the variable analysis looked at the percentage of compliance with standards based on the Minister of Health Regulation No. 74 of 2016.  

Deski Bertolens Tungga; Thelma S.M Kadja; Heryanto Amalo

Jurnal Hukum, Administrasi Publik, dan Ilmu Komunikasi 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

According to data obtained from the Food and Drug Supervisory Agency (BPOM), the total number of illegal cosmetics and/or containing prohibited/dangerous ingredients during the period from October 2021 to August 2022 was more than 1 million pieces with an economic value of IDR 34.4 billion. BPOM also followed up on findings based on reports from several drug and food supervisory authorities in other countries. Based on the report, as many as 46 (forty-six) cosmetics were withdrawn from circulation because they contained prohibited ingredients, microbial contamination, or were counterfeit cosmetics. During the same period, BPOM also carried out cyber patrols. This cyber patrol was carried out on website, social media, and e-commerce platforms to trace and prevent the circulation of illegal cosmetics and BPOM found and blocked (takedown) 83,700 links to the sale of illegal cosmetic products and containing prohibited/dangerous ingredients with a total product amount of 6.5 million pieces and an economic value of Rp 296.9 billion. This proves that there are still many illegal cosmetic products that contain harmful ingredients and do not have a distribution permit.  This research is a normative legal research supported by a statutory approach (statute approcach) which uses secondary data in the form of primary legal materials, secondary legal materials and tertiary legal materials that collect laws and regulations related to the legal issues at hand, case studies, collecting books, journals, dictionaries and other related literature. The legal materials that have been successfully collected are analyzed, namely description, interpretation, evaluation and systematic. The results of this study show that (1) Based on the form of consumer protection from the criminal aspect, there are five forms of consumer protection, namely: Protection against Unsafe Products; Fraud and Fraud Violation of Clear and Correct Information; Violations of Consumer Rights; Abuse of Power or Dominant Position, as well as unfair business practices. Criminal sanctions aim to provide a deterrent effect to business actors who harm consumers. (2) Based on the perspective of criminal law, the actions of DM business actors who have circulated illegal cosmetics without a distribution permit in decision number 572/Pid.Sus/2022/PN Smr, violate the provisions of Article 197 of Law Number 36 of 2009 concerning Health, which has affirmed that every person who deliberately produces and/or distributes pharmaceutical preparations and/or medical devices without having a distribution permit as mentioned in Article 106 paragraph (1) is criminally punished imprisonment for a maximum of (fifteen) years and a maximum fine of Rp.1,500,000,000,- (one billion five hundred million rupiah).

Diana Ndun; Orpa Ganefo Manuain; Rosalind Angel Fanggi

Jurnal Kajian Ilmu Sosial, Politik dan Hukum 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

This research is a normative research, so this data is carried out by conducting a literature study on the verdict. Data sources are obtained from primary legal materials, namely: laws and regulations and court decisions, secondary obtained from literature and literature studies, tertiary legal materials obtained from the internet, dictionaries, and encyclopedias. The results of the research obtained from analyzing the verdict show that (1). The basis for the judge's consideration in imposing criminal sanctions against distributors of pharmaceutical preparations without expertise and authority by looking at the Judge's Juridical Considerations and Non-Juridical Considerations of the judge is appropriate and uses an Article that meets the elements of the perpetrator's violation in accordance with the Health Law, but the imposition of criminal sanctions is very light and far from the provisions of the Article. (2). The suitability of the imposition of criminal sanctions in Decision Number 150/Pi.Sus/2021/PN Kupang with the Health Law given by the Judge to the defendant is so light that it cannot guarantee that the defendant will feel frustrated and will not repeat his actions again. This makes the sense of justice, usefulness and legal certainty not fulfilled properly. The author's suggestion that the criminal sanctions imposed by the Panel of Judges against the defendant should not only consider the behavior and actions of the defendant but also look at the consequences of the defendant's actions that can have a bad impact on the health of consumers/patients who take the hard drug.

Adrianty Charmelita Valentine Mali; Deddy. R. CH. Manafe; Rosalind Angel Fanggi

Jurnal Kajian Ilmu Sosial, Politik dan Hukum 2024 Asosiasi Peneliti dan Pengajar Ilmu Hukum Indonesia

Health is a state of health, both physically, mentally, spiritually and socially that allows everyone to live productively socially and economically. Health is based on legal provisions, including health law. The development of criminal acts in the field of health sciences One of the crimes in health law that is rampant is the crime in the field of pharmacy, one of which is circulating pharmaceutical preparations of drugs without a distribution permit. Drugs without a distribution permit cannot be freely traded to the public. This is not without reason, unlicensed drugs must be consumed in the right dosage so as not to endanger the health of the public or the people who consume the drug. This research is a normative juridical research using secondary data through literature studies, namely by using research on various sources of books, laws and regulations related to the crime of producing and distributing pharmaceutical preparations without a distribution permit. From the research conducted, it can be concluded that the application of criminal sanctions against criminal offenders who circulate pharmaceutical preparations without a distribution permit is contained in several laws and regulations, namely, Law No. 17 of 2023 concerning Health and Law No. 36 of 2009 concerning Health as a means of crime prevention. The implementation of this law is expected to ensnare the perpetrators of the crime of distributing pharmaceutical preparations without a distribution permit.

Wuri Ariestika Sari; Eri Amalia

Jurnal Riset Ilmu Farmasi dan Kesehatan 2024 Asosiasi Riset Ilmu Kesehatan Indonesia

Cold Chain Products are pharmaceutical preparations sensitive to temperature, requiring consistently maintained temperature conditions from production, storage, and transportation to the final consumer. Environmental changes, such as temperature fluctuations and direct sunlight exposure, can reduce product quality, leading to the loss of the product's therapeutic potential. Therefore, Pedagang Besar Farmasi (PBF) play a crucial role throughout the distribution chain of cold chain products to ensure that the quality and effectiveness of the products are maintained. This study aims to evaluate the implementation of cold chain product management at a PBF in Tasikmalaya City according to the applicable guidelines, namely the Good Distribution Practices (CDOB). The study employs observation and interview methods, with evaluation using a research tool in the form of a checklist developed based on aspects of cold chain product management according to the 2020 CDOB guidelines. Based on the evaluation of cold chain product management implementation according to CDOB, a PBF in Tasikmalaya City has successfully implemented CDOB aspects well.

Cikra Ikhda Nur Hamidah Safitri; M. Rizky Arif; Andri Priyoherianto; Lisa Rahmalia Hildiana; Hartono Hartono

Jurnal Rumpun Ilmu Kesehatan 2024 Pusat Riset dan Inovasi Nasional

Pharmaceutical Services at the Hospital is an integral part of the Hospital's health care system that is patient-oriented, providing Pharmaceutical Preparations Medical Devices, and Medical Materials that are quality and affordable for all levels of society including clinical pharmacy services (Anonymous, 2016) Besed on the Decree of the Minister of Health of the Republic of Indonesia No 179 Menkes/SK/11/2008, the SPM indicator of hospital pharmacy services includes the waiting time for drug services to be a maximum of 30 minutes while the maximum concoction drug is 60 minutes, the absence of medication errors, stalaction customers at least 80% and prescription writing all must refer to the Hospital formulary This study aims to find out the Waiting Time (Respond Time) of Prescription Services for Finished Medicines and drugs mixed with BPJS patients Outpatient in Bangil Hospital. This research is a non-experimental research with descriptive approach, namely the type of research approach to obtain an overview of the state of a group of data based on observations the real thing is, data collection is done in the Outpatient Pharmacy Service at Hangil Hospital, and is carried out for three months. The total mumber of prescription samples erered in the pharmacy installation for three months a 12.587 prescriptions with details of 10,770 prescriptions of JKN BPJS 85.27% 1,808 peral recipes 14 66% and 9 other insurance recipes 0.07% Among the recipe for JKN BPIS obtained during the study were 90.23% of non-concoction recipes and 9.77% of recipe recipes. The results of the study were obtaining results, the number of prescriptions from patients was 85.27% more than prescriptions from general patients 14 66% and other insurance 0.07%. The average waiting time for non-concoction recipe services in 25 minutes, and concoctions are 62 minutes

Djulfikri Mewar; Marisa Anggia Ibrahim; Pikra Parwak

Jurnal Rumpun Ilmu Kesehatan 2024 Pusat Riset dan Inovasi Nasional

Nutmeg seeds are one of the herbs and spices that are rich in benefits and the content of alkaloids, flavonoids and saponins other very important roles in its utilization. Nutmeg seeds contain trimyristin which its content can be used in the manufacture of liquid bath soap. One of the application of the compound contained is made in the form pHarmaceutical preparations. Liquid soap is made through a saponification reaction from oil and fat reacted with KOH. This research. aim to do optimization of liquid soap formula between concentration variations of 8%, 9%, 10% so can find out the optimum liquid soap formula and know the evaluation of properties pHysics and chemistry of preparations. Nutmeg seed extract is obtained by extraction using the maceration method using 70% ethanol solvent, then carried out evaporation using a rotary evaporator instrument until the extract is obtained thick. Formulation of liquid soap by heating method for 45 minutes. Evaluation preparations include organoleptic observations, homogeneity. pH, foam height. Results showed that the liquid soap formulated from elstract: colored nutmeg brownish, has a characteristic odor of nutmeg seed extract, is in the form of a homogeneous liquid, has a pH pH 8-10, foam height 93mm-139mm. Optimum formula based on results showed no significant difference from all formulas. Variation concentration 8%, 9%, 10% pH test and high foam test. the formula has complied requirements in accordance with the standards set by SNI 06-4085-1996. Where the normal pH of liquid soap is ph 8-11 and the high foam of liquid soap is 13mm-220mm  

Ayu Rahmawati; Edi Suhardiana

Jurnal Anestesi: Jurnal Ilmu Kesehatan dan Kedokteran, 2023 Stikes Kesdam IV/Diponegoro Semarang, Indonesia

Drug storage is one of the security activities for drugs that have been received. Storage of drugs in pharmacy installations is part of the integrity or feasibility of drugs before they are given to patients. Because errors in drug storage can make the dose or potency of the drug decrease and cause losses to the hospital. This research includes non-experimental research in the form of quantitative descriptive research conducted by observation and interviews related to the process of storing pharmaceutical preparations through an evaluation based on the Minister of Health of the Republic of Indonesia No. 72 of 2016, and the Director General of Binfar in 2010 and analysis of drug storage indicators. The average result of conformity to the Permenkes is 86%, the average is obtained from 70% storage requirements, 100% storage components, 100% storage systems, 80% storage methods and 80% storage equipment. The average result of conformity at the Director General of Binfar is 93%, the average is obtained from the spatial arrangement of 100%, preparation of 100% drug stock and 80% storage facilities. And the average results of storage indicators are 40%, with a TOR value of 5,1 times a year, warehouse arrangement is based on FIFO/FEFO, the percentage of expired/damaged drugs is 0.25%, and the percentage of empty drugs is 92%, the percentage of drugs dead by 0.04%. Based on the evaluation of the suitability of drug storage in the Pharmacy Warehouse of RSUD dr. Soekardjo, City of Tasikmalaya, it is necessary to increase the suitability of drug storage.

Rico Sentosa Sihombing; Rena Meutia

Jurnal Ventilator: Jurnal riset ilmu kesehatan dan Keperawatan 2023 Stikes Kesdam IV/Diponegoro Semarang, Indonesia

Black cumin oil (Nigella Sativa Linn) is rich in antioxidants. One of the substances contained in black cumin oil (Nigella Sativa Linn) which acts as an antioxidant is thermoquinone. Cream is a widely chosen preparation because it is one of the pharmaceutical preparations that is used topically for the treatment of various skin diseases. The purpose of this study was to determine whether Cumin (Nigella Sativa Linn) Oil (Nigella Sativa Linn) can be formulated as a cream dosage form. to find out the optimum concentration of black cumin oil cream formulation (Nigella Sativa Linn) with cream base variations (Stearic acid and TEA).This research is a longitudinal-experimental study. The tools used in this study were glassware, watch glass, evaporating cup, parchment paper, universal pH indicator, digital scale, mortar, stamper, waterbath, refrigerator, stirring rod, tweezers, spirit lamp, loop needle. The materials used in this study were Black Cumin (Nigella Sativa Linn) oil, TEA, White wax, Stearic Acid, White Vaseline, Methyl paraben, PEG, Aquadest. For organoleptic testing of cream, it can be seen from the observation of color, smell, and texture. The evaluation was carried out including organoleptic tests for homogeneity, absorption, and pH tests. Based on the research results, it can be concluded that black cumin oil can be formulated into cream preparations with varying concentrations of stearic acid and triethanolamine, although there are several tests that do not meet the requirements for cream preparation tests. The combination of stearic acid and triethanolamine with different concentrations can affect the physical quality which includes pH, spreadability and mechanical stability but has no effect on the organoleptic, cream type and homogeneity.

Hani Putri Febriyanti; Rhaina Al Yasin; Rossa Shafira Nur Sabrina; Novita Dwi Istanti

Jurnal Anestesi: Jurnal Ilmu Kesehatan dan Kedokteran, 2023 Stikes Kesdam IV/Diponegoro Semarang, Indonesia

Pharmaceutical preparations is a term that covers all forms of pharmaceutical preparations ranging from drugs, medicinal ingredients, traditional medicines to cosmetics. This term has been regulated in Government Regulation of the Republic of Indonesia Number 51 of 2009 concerning Pharmaceutical Work. Management of pharmaceutical preparations is a cycle of activities starting from the selection, scheduling needs, receiving, storage, distribution, destruction and withdrawal, control, which is necessary for pharmaceutical service activities. The method used in this study is a Systematic Literature Review (SLR) of ten national journals which were obtained using online database facilities via the Google Scholar, Refseek, and Sciencegate pages. Journals were selected based on publications published between 2018 and 2023. There were obstacles in the implementation of pharmaceutical preparations, including planning that was still conservative, from delays in drug procurement in demand and distribution, resulting in empty drug supplies. However, not all aspects are problematic. There are many other aspects of the mechanism of pharmaceutical preparation that are carefully programmed and procedurally appropriate. This matter needs to be done routinely and continuously, and with written commitments for pharmaceutical preparations in Indonesia in supporting SKN it can be categorized as quite good.

Suhaera Suhaera; Suci Fitriani Sammulia; Reny Haryani; Shinta Sari Dewi

Jurnal Rumpun Ilmu Kesehatan 2021 Pusat Riset dan Inovasi Nasional

Snail Gong-gong (Strombus Turturella) is a typical food of the people of Riau Islands. The processed food produces the waste of a well-utilized shell. The main composition of the gong-gong slug is calcium carbonate (CaCO3). With the content of calcium, the waste shell of gong-gong can be used as raw material for the preparation of pharmaceutical preparations such as suction tablets. This study aims to obtain the formulation of a lozenges from the waste of gong-gong shell with good physical properties. A lozenges is made by a method of wet granulation in three formulas with variations in the concentrations of the case of the F1 gong-gong 15%, F2 30%, and F3 45%. The granules and tablets are evaluated. The results of the granule evaluation showed that the granule produced from the three formulas has fulfilled the requirements, the results of the tablet evaluation showed on organoleptic test, size uniformity, hardness, disintegration time of all three formulas have fulfilled good lozenges requirements. While the weight uniformity of F1 is not eligible, the friability test F1 and F2 are not eligible. The results of this study showed that the gong-gong snail shells can be formulated into a lozenges and have good physical properties.

Sukma, Rakasyiwa Rewangga; Suliantoro, Adi

DINAMIKA HUKUM 2021 Universitas Stikubank

September 13, 2019, the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) issued a warning through the official FDA website, that contaminants were found that were thought to trigger cancer. It is known that the contamination is an impurity or nitrosamine compound or commonly called N-Nitrosodimethylamine (NDMA) which is included in chemical contamination originating from chemical elements or compounds that can endanger human health. Symptoms that appear are the skin and the whites of the eyes turning yellow, fatigue, darker urine, and abdominal pain. Based on this, there is a problem that needs to be analyzed, namely how the law protects consumers from consuming these materials, especially in the city of Semarang, are there any obstacles in the effort to protect consumers from consuming drugs containing NDMA. The methodology used in this research is juridical normative with secondary data, which is analyzed by analytical descriptive. The results of the analysis, it is known that the state through various provisions has protected consumers from consuming hazardous materials, including those in Article 8 "Regarding actions that are prohibited for business actors; Law Number 36 of 2009 concerning Health Articles 98, 99, 104 & 106 "Regarding the Security and Use of Pharmaceutical Preparations and Medical Devices" AND Regulation of the Minister of Health of the Republic of Indonesia 101 / MENKES / PER / XI / 2008 concerning Drug Registration. That in this protection effort, the government c.q BPOM is experiencing internal and external obstacles. Internal constraints, namely limited human resources and still low external business actors to meet the requirements for good production methods, with relatively low legal sanctions.   Keywords: Consumer Protection, NDMA Drugs, BPOM