Indian Pharmacopoeia Research Articles

QbD method to the formulation and development of a spironolactone immediate-release tablet with enhanced dissolving research

This work aimed to improve the solubility of medication D (Spironolactone) by encapsulating it in HPCD and constructing an inclusion complexation using the kneading process. All of the formulations were put through a series of tests based on Indian pharmacopeia. All of the generated formulations were tested in vitro for drug release, and the optimal formulation was also subjected to stability tests. In terms of superior solubility profile and increase in dissolving rate, the inclusion complex created with HPCD and drug concentration of 1:1 M ratio was the best formulation among the eight batches of inclusion complex prepared. Direct compression technology produces immediate-release tablets of medication D with a quality-by-design approach. The prepared tablet in the optimal formulation has good mechanical strength, appropriate Hardness, and less than 1% friability. All batches passed the weight variation test, and the limit was kept within the Pharmacopeial standard of 5% of the total weight. The improved formulation's drug content was determined to be between 97 and 100 percent, with a disintegration time of 1 to 12 min for Spironolactone. The formulation containing Crospovidone disintegrated quickly, with medication release reaching more than 97 percent after 10 min.

Pharmacovigilance and materiovigilance in India: A review

: Pharmacovigilance defined by the world health organization as "the science and activities relating to the detection, assessment, understanding, assessment and prevention of adverse effects or any other drug related problems". It plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug’s adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes both at a regulatory and scientific level are being developed with the aim of strengthening pharmacovigilance and materiopvigilance. On a regulatory level, transparency and increased patient involvement are two important elements [1]. similarly Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety.

Evaluation of Anti Ulcerogenic Potential of Plant Extract of Morinda tinctoria

M. tinctoria plant has many therapeutic uses in traditional Indian medicine. M. tinctoria has Antibacterial, Antifungal, Hepatoprotective, Antioxidant, Wound Healing, Dye Yielding and Larvicidal properties. The study is employ to the anti- ulcerogenic potential of M. tinctoria extract. The plant extraction was done with 50% ethanol and 50% water (hydro-alcoholic). OECD guidelines were used for acute- toxicity (14 days) and Sub-acute toxicity (28 days). The study was carried by ligation (pylorus) and drug-induced ulcer models in Wistar rats. The anti-ulcer activity of M. tinctoria was compared with the standard drugs to perceive the anti-ulcerogenic potential. The Pharmacognostic analysis was performed according to the Indian pharmacopoeia. A preliminary Phytochemical test of the aerial part of M.tinctoria was performed which showed the presence of carbohydrates, amino acid, glycosides, flavonoids, alkaloids in the hydro-alcoholic extract. Acute-oral toxicity (14 days) and Sub-acute oral toxicity (28 days) were performed and doesn’t show any effect on body weight as well as organ weight and was non-toxic. M. tinctoria extract (MTE) effectively prevents the gastric mucosa from the threat of ulcers caused by pylorus ligation and aspirin-induced ulcers. MTE demonstrated a substantial reduction in the ulcer index developed by all 2 experimental models comparable to the standard drug Omeprazole. Current evidence shows that aerial parts of MTE have substantial antiulcer action.

Standardization of Berberis aristata DC and Nigella sativa L. Using HPTLC and GCMS and Their Antineoplasia Activity in 7,12-Dimethylbenz[a]anthracene-Induced Mouse Models.

Berberis aristata DC and Nigella sativa L. are officially listed in various Indian Pharmacopoeia and AYUSH official documents. Prescribed for different ailments for proven medicinal activities, they thus became part of polyherbal medications. With reverse pharmacology and scientific validation, more than 30 patents are filed on different formulations of B. aristata and granted. Nigella sativa L. has been broadly studied for its therapeutic potential and wide range of activities against cardiovascular, diabetic, cancer, and life style disorders. Thus, this study is aimed at standardizing B. aristata and N. sativa and their antineoplasia activity in 7, 12-dimethylbenz[a]anthracene (DMBA)-induced mouse models. Molecular docking was done using the Schrodinger program Maestro 9.0. Herbal extracts and essential oil (B. aristata and N. sativa) were standardized and quantified using high-performance thin-layer chromatography (HPTLC) (CAMAG) and gas chromatography–mass spectrometry (GCMS) (Agilent 2010GC System) with validated methods. DMBA was administered orally once a week (1mg/200 µL) to each animal except the normal control. Hematology, histopathology, and immunoassays were performed, and data were analyzed and depicted with GraphPad and SPSS. In molecular docking, thymoquinone showed the highest docking score (9.519, 9.211, and 9.042, respectively) in the active site pockets of IL6 (PDB ID: 4CNI and 5FCU), TNF (PDB ID: 2AZ5), and VEGF (PDB ID: 4KZN). Out of all four target sites, thymoquinone and berberine showed good binding affinity with IL6 (PDB ID: 4CNI) compared to α- and β-pinenes. HPTLC analysis of the hydroalcoholic extract showed the presence of berberine both qualitatively and quantitatively (5.4% berberine), and thymoquinone detected 0.17% in the N. sativa extract. GCMS for essential oil showed 26 compounds including ±pinene. Leukocytes and erythrocytes of N. sativa and B. aristata were analyzed, and significant improvements were recorded (P < 0.05) and graphically presented. Mean survival time was calculated by the Kaplan Meier method (119 days). Immunoassay analyses were conducted, namely, TNF-α and VEGF, and interpreted and marked.

Physicochemical Evaluation of Diploknema butyracea Seed Extract and Formulation of Ketoconazole Ointment by Using the Fat as a Base

The fat obtained from the ripened seeds of Diploknema butyracea is widely used as a vegetable oil in rural areas of Nepal. This study was aimed for the physicochemical evaluation (acid value, iodine value, saponification value, peroxide value, ester value, pH, and liquefaction point) of the Diploknema butyracea seed extract (chyuri fat) and the formulation of 2% w/w ketoconazole ointment by using it as a base. All the physicochemical parameters were determined quantitatively by using the method of Indian Pharmacopoeia (IP), volume-I. By fusion method, 3 different formulations F-A, F-B, and F-C were prepared, in which different proportions of chyuri fat, polyethylene glycol 6000 (PEG 600), Tween 80, and propylene glycol were used as an ointment base. Various quality parameters such as spreadability, extrudability, viscosity, smoothness, pH, average fill weight, assay, content uniformity, accelerated stability, and drug release profiles were determined. HPLC was used for the determination of ketoconazole content in the ointment formulations. Physicochemical evaluation of the chyuri fat ensured its suitability for industrial purpose. The active ingredient release profile of formulations F-A (87.71%), F-B (88.89%), and F-C (91.09%) after 5 hours were within acceptable range along with other parameters. Assay of the formulations F-A, F-B, and F-C were reported to be 103.01, 107.9, and 102.45%, respectively. Overall, evaluation of the formulation F-A, prepared by using chyrui fat only, gave satisfactory results and most of the parameters were statistically similar (p&gt;0.05) to the F-B and F-C formulated by incorporating a certain proportion of synthetic base. Thus it can be concluded that chyuri fat can be the best alternative to replace the expensive synthetic base.

Adverse Drug Reactions in the Pediatric Population: Findings From the Adverse Drug Reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020).

Background and objectiveThe incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India.MethodsThis was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis.ResultsThe largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent.ConclusionsOne-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.

Bio-scouring of Non-spinnable Cotton by a Crude Enzyme of a New Fungal Strain Aspergillus sp. VM-1, Isolated from Banana Pseudostem Waste

In the present study, we isolated and identified a new fungus, Aspergillus sp VM-1 from banana pseudostem waste. The fungal strain, Aspergillus sp. VM-1 was grown on a substrate (banana pseudostem, cottonseed hulls and cottonseed meal in the ratio of 60:30:10, respectively) for 7 days and the crude enzyme was extracted from the fermented substrate. The pectinase activity in crude enzyme extract was 551 (U/ml). The crude enzyme extracted from Aspergillus sp. VM-1 was evaluated for bio-scouring of non-spinnable cotton. The non-spinnable cotton taken in the study was short staple cotton (SSC), cotton linters (CL) and non-woven cotton fabric (NWCF). The maximum absorbency (2 s) in non-spinnable cotton was achieved under optimized process conditions: enzyme extract level (40%), temperature (40 ± 2 °C) and time (40 min). The quality parameters of bio-scoured cotton meet the Indian Pharmacopoeia (IP) standards. A solid state fermenter was designed to scale-up the crude enzyme production up to 30 l. This is the first report on bio-scouring of under-utilized short cotton fibres at lower temperature (40 ± 2 °C). The present study offers a simple and eco-friendly bio-scouring process as an alternative to toxic chemical scouring of under-utilized short staple cotton fibres.Graphic Supplementary InformationThe online version contains supplementary material available at 10.1007/s12649-021-01621-9.

Development and Stability of Forced Degradation Studies Indicating Different Brands of Metformin Drugs

In present study, Accouring to specification of Indian pharmacopeia the content official limit of not less than (98.5%) and not more than (101.0%) of the lable amount our hypothesis was that when all different brands of metformin were expose to the different degradation parameters. The Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and package. A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions.

Biotechnological production of diterpenoid lactones from cell and organ cultures of Andrographis paniculata.

Andrographis paniculata (AP) is a medicinal plant that is traditionally used in Indian, Chinese, Malay, Thai, and Oriental system of medicines to treat various disorders. AP consists of andrographolide (AD), 14-deoxy-11,12-didehydroandrographolide (DDAD), and neoandrographolide (NAD) as major diterpene lactones which has extremely bitter properties; therefore, AP is commonly called "King of bitters." AD, DDAD, and NADare reported to possess therapeutic values such as antioxidant, immunostimulatory, hepatoprotective, anti-cancer, anti-inflammatory, anti-rheumatoidal, anti-malarial, anti-leishmanial, anti-fertility, anti-obesity, antipyretic, and antimicrobial attributes. According to the Indian Pharmacopoeia, the leaves and tender shoots of AP yield up to 1%, 0.16%, and 0.11% of AD, DDAD, and NAD, respectively, on a dry-weight basis. However, variability in the accumulation of AD, DDAD, and NADin plants has been reported with respect to species, genotype, season, phenological stage, plant part used, and geography of a region of cultivation. Therefore, cell and tissue culture systems especially cell, shoot, and adventitious root cultures are explored as alternatives for constant and higher production of AD, DDAD, and NAD. This review explores the prospects of exploiting the plant cell and tissue culture systems for the controlled production of AD, DDAD, and NAD. Various strategies such as elicitation by using biological and chemical elicitors are explored for the enhancement of accumulation of AD, DDAD, and NAD in cell and organ cultures. KEY POINTS: • This review explores the possibilities of diterpene lactone production from cell and organ cultures. • Various strategies are explored for the enhanced accumulation of AD, DDAD, and NAD in cell and organ cultures. • Prospects of diterpene lactone production are highlighted.

RbcL, a potential candidate DNA barcode loci for aconites: conservation of himalayan aconites.

Aconitum heterophyllum Wall. ex Royle and Aconitum balfourii Stapf, are two highly important, threatened medicinal plants of the Indian Himalayan Region. Root-tubers of Aconites have occupied an important place in Indian pharmacopoeia from very ancient times. India is a hub of the wild-collected medicinal herbs industry in Asia and these two aconites are known to have been heavily traded from the region in illicit manner. Prosecution of these illegal trading crimes is hampered by lack of pharma-forensic expertise and tools. Present study was conducted to evaluate the discriminatory potential of rbcL, a Chloroplast based DNA barcode marker for the authentication of these two Himalayan Aconites. Fresh plant samples were collected from their natural distributional range as well as raw materials were procured from herbal market and a total of 32 sequences were generated for the rbcL region. Analysis demonstrated that rbcL region can successfully be used for authentication and importantly, both the aconites, were successfully discriminated by rbcL locus with high bootstrap support (> 50%). Molecular markers could certainly be relied upon morphological and chemical markers being tissue specific, having a higher discriminatory power and not age dependent. Phylogenetic analysis using Maximum Likelihood Method revealed that the rbcL gene could successfully discriminate Himalayan Aconites to species level and have potential to be used in pharma-forensic applications as well as to curb illicit trade of these invaluable medicinal plants.

Physicochemical characterization and HPTLC profiling of commercially available Kabasura Kudineer Chooranam

The novel coronavirus disease-2019 (COVID-19) is an ongoing pandemic and currently, no specific vaccines or modern drugs are available to combat this contagious viral disease. Kaba sura kudineer, an official polyherbal Siddha medicine containing numerous herbal ingredients, is being practiced primarily in southern parts of India in the management of COVID-19 pandemic for boosting the respiratory system and treating fever with flu-like symptoms. The present study is carried out to scientifically validate the traditional claim and to confirm identity, quality and purity of marketed kaba sura kudineer polyherbal formulations in India. Kabasura kudineer chooranam manufactured by two different manufacturers were procured from New Delhi, India. The physicochemical characterization of the samples was carried out in accordance with the standards laid down by Indian Pharmacopoeia (IP) 2018. HPTLC profiling of key ingredients including Kalmegh ( Andrographis paniculata ), Guduchi ( Tinospora cordifolia ), Pippali ( Piper longum ), Vasaka ( Adhatoda vasica ) and Lavang ( Syzygium aromaticum ) were also carried out in accordance with IP 2018 monographs. The chromatographic analysis showed presence of all major ingredients in both the marketed preparations and all the physicochemical properties were also found comparable among preparations. Our findings may enhance the global acceptance of Siddha medicines practiced widely in India and also used for laying down the pharmacopoeial standards of kaba sura kudineer chooranam.

ANALYSIS OF QTC PROLONGATION DUE TO BEDAQUILINE IN TUBERCULOSIS PATIENTS – A RETROSPECTIVE STUDY.

Introduction: Bedaquiline should is administered under direct observation along with standard MDR-TB regimen. Recommended dose is 400 mg once daily for 2 weeks followed by 200 mg thrice weekly for 22 weeks. After 24 weeks of Bedaquiline therapy, MDR-TB regimen should be continued as per national TB treatment guidelines. The observed prolongation of the QT interval and potentially fatal cardiac arrhythmia may or may not be related to interference with membrane associated cation transports.&#x0D; Aims and objective: To analyze QTc Prolongation in patients who received Bedaquiline in District tuberculosis center at Rajkot.&#x0D; Material and method: All the patient who received and actively followed and developed QTc prolongation as Adverse Drug Reaction were included in the study. Demographic parameter and detailed information about ECG changes due to QTc Prolongation was noted from patient treatment sheet. Interim analysis was done in this study. Adverse drug reactions data was collected in Adverse Drug Reaction(ADR) form (version 1.3) by Indian Pharmacopoeia Commission. The ADR related data can be accessed through - https://vigiflow-in.who-umc.org.&#x0D; Result: Total 30 patient who received Tablet Bedaquiline were included in the study. Out of which 18 (60%) were males and 12 (40%) were females, Mean age of patient was 28.3 (years) ± 11.6 SD, Mean weight of patient was 48.2 (kg) ± 5.6 SD and 2 patient died due to cardiac arrest.&#x0D; Statistical analysis: Descriptive analysis like mean, standard deviation and percentage was done using excel office version 2016.&#x0D; Conclusion: Long QTc prolongation was noted more among male patients weighing 41 to 50 kg. Among all the participant, majority were having QTc prolongation and two death were observed during treatment of Bedaquiline. The patients will be further followed up for outcome analysis.&#x0D; Keywords: Bedaquiline, QTc interval, adverse effect.

Formulation and Evaluation of Salbutamol Sulphate Taste Masked Oral Disintegrating Tablets

Salbutamol is a short acting, selective beta2-adrenergic receptor agonist used in the treatment of astama and COPD. The aim of this study is to formulate oral disintegrating tablets of salbutamol sulphate to achieve rapid dissolution, absorption and further improving the bioavailability of the drug. Oral disintegrating tablets of salbutamol sulphate were designed with a view to enhance the patient compliance and provide a quick onset of action. The oral disintegrating tablets were prepared by using different synthetic polymers by direct compression method. Development of the formulation in the present study was based on the concentration of superdisintegrants and the properties of the drug. Nine batches of tablets were formulated and evaluated for various parameters: drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity, and in vitro dissolution. A fourier-transform infrared spectroscopy (FTIR) study showed that there were no significant interactions between the drug and the excipients. The prepared tablets were good in appearance and showed acceptable results for hardness and friability. The in vitro disintegrating time of the formulated tablets was found to be 14.39-32.41 sec and the drug content of tablets in all formulations was found to be between 87.48-99.96 %, which complied within the limits established in the Indian pharmacopeia. The study concluded that taste of the drug was masked with the help of sodium saccarhin, flavor and the concentration of super disintegrating agent increases the disintegration time of tablets get decreases. The formulation (F9) had a minimum disintegration time of 14.39 sec and 99.96 % of the drug was released within 20 min.

Second wave of COVID-19 pandemic and the surge of mucormycosis: Lessons learnt and future preparedness: Indian Society of Anaesthesiologists (ISA National) Advisory and Position Statement.

Second wave of COVID-19 pandemic and the surge of mucormycosis: Lessons learnt and future preparedness: Indian Society of Anaesthesiologists (ISA National) Advisory and Position Statement.

FORMULATION, CHARACTERIZATION AND IN-VITRO DISSOLUTION STUDIES OF METADOXINE TABLETS PREPARED BY VARIOUS GRANULATION METHODS

Pharmaceutical tablets are robust, flat, or biconvex dishes, according to the Indian Pharmacopoeia. Depending on a range of medicinal substances, they vary in shape and differ greatly in size and weight. In the era of increasing health awareness and strict standards set by regulatory authorities such as the US FDA, WHO, and globalization, it has become mandatory for the producer to launch a product cost-effectively. In the tablet dosage form, two classes of drugs are administered orally. Narrow extensions of the parietal peritoneum that suspend the diaphragm's liver are the right and left coronary ligaments. To produce an effective and reliable product, the drug must have a fine particle size and a large surface area. The tablet coating takes place inside a perforated rotating drum in a controlled atmosphere. Tablets are lifted and turned into the center of the drum from the sides. To make the tablet surface easier to swallow, every tablet surface is exposed to an even amount of deposited/sprayed coating. The purpose of the present investigation is to formulate a tablet of Metadoxine, which improves cognitive impairment and the main psychological symptoms due to occasional or prolonged alcohol abuse, such as aggressiveness, agitation, mood, and behavioral disturbances. The tablets were prepared using direct compression, dry granulation, and wet granulation method and a comparison of the same with an innovator’s product. Keywords: Tablets, Metadoxine, Dry granulation, direct compression, wet granulation.

Exploring green and industrially scalable microfluidizer™ technology for development of barium sulphate nanosuspension for enhanced contrasting

Barium sulphate (BS), usually administered as an oral suspension, is a widely prescribed GI contrast agent. Consumption of BS is reported with side effects like mild stomach cramps, nausea, vomiting, diarrhoea, etc. This can be attributed to its high dosage, which is 9 g and 18 g in infants and adults, respectively. Considering its physicochemical properties, one approach to minimize BS dose is formulating its nanosuspension dose due to the higher surface area to volume ratio of nanoparticles. We formulated BS nanosuspension with the help of an industrially scalable and green Microfluidizer technology. Nanonization of coarse suspension was performed using Microfluidizer technology. The microfluidization process was optimized for parameters like the number of cycles and pressure to achieve the desired stable sub-micron particle size. A quantitative gravimetric assay was performed as per the protocol mentioned in the Indian Pharmacopeia. Ex vivo mucoadhesion studies were performed on intestinal tissue samples from goat. Comparative contrasting efficacy of the developed nanosuspension with the marketed formulation was evaluated in vivo in rabbits. The average particle size of coarse BS suspension was 20 μm. After subjecting to optimized microfluidization, the particle size of 700 nm was achieved. The formulation was found to be stable for 6 months as per ICH guidelines. BS nanosuspension showed better contrasting as compared to the marketed formulation in in vivo studies. A greener, industrially scalable microfluidization technology was successfully used for the fabrication of BS nanosuspension that has translational potential, with a prospective reduction in side effects of the current formulation.

Comprehensive Data of Spontaneous Adverse Drug Reactions Reporting

Underreporting is a matter of concern for Pharmacovigilance Programme of India. Since multiple interventions are needed to improve ADR reporting. In 37 studies performed in 12 countries, the median under reporting was 94%. Even for the drug combinations it was as high as 85%. Even in general practice, the concern was underreporting of the spontaneous reporting systems. The spontaneous reporting initiative is often passive which relies on the healthcare professionals to detect and take the initiative to report an ADR. Spontaneous reports play a major role in the identification of safety signals once a drug is marketed. In many instances, a Marketing authorization holder can be alerted to rare adverse events that were not detected in earlier clinical trials or other pre-marketing studies. In India, Indian Pharmacopoeia Commission (IPC) and National Coordination Committee (NCC) along with the Central Drug Standard Control Organization (CDSCO) together regulate the PV activity. The Spontaneous ADR reporting form can be downloaded from CDSCO website. It captures all features essential for reporting a ADR This is similar to Yellow card of UK, Australian Blue Card and in US as Med watch.

PHYTO-PHARMACEUTICAL DEFINITION UNDER DRUG REGULATIONS, INDIA NEEDS AN URGENT REVIEW

Dear Reader, An Amendment to the Drugs and Cosmetics Regulations to permit scientifically developed plant based leads as drugs named “phytopharmaceuticals”, was notified for the first time in November 2015. This regulation has now been further amended and revised to put it under new drug definitions and provided more provisions for greater clarity in 2019. However, having championed these regulations (as part of the Indian Pharmacopoeia Commission’s Expert Committee on Herbals) for nearly a decade a greater number of drugs should have come out through this route given the scientific capability of the Indian drug sector and academia. However, the only information in the public domain as on date is the approval for conducting human clinical trials of a plant based lead for testing the protective or curative potency of Coculous hirsutus against SARS – CoV-2 given by the Drugs Controller General of India. A purified fraction of the stem of this plant commonly called broom creeper has been tested for sinnococculine markers as the lead drug candidate.

A Comparative Study of Pharmacopoeial Quality Standards and Regulations of Radiopharmaceuticals.

Radiopharmaceutical preparations are the important pharmaceutical dosage forms used for the diagnosis and therapeutic purposes. Various pharmacopoeias are having methods for the quality control of these preparations in the form of monographs. Indian Pharmacopoeia (IP) also included these monographs in IP 2014 first time with the help of an experts' group on radiopharmaceutical, drawing expertise from elite stakeholder institutions and the core team of Indian Pharmacopoeia Commission. Since then, these standards are regularly updated through the IP addendum and bringing out new edition of IP. IP is a book of official methods as per Drugs and Cosmetic Act, 1940. These standards can be used in government laboratories, private laboratories, or academia in India and abroad. This review provides an overview of the journey of radiopharmaceuticals' standard setting in IP. A comprehensive comparative information of regulatory perspectives of radiopharmaceuticals in different jurisdictions such as the US, EU, and India is also presented.

Formulation and evaluation of mucoadhesive buccal tablets of aceclofenac

This project was aimed to formulate and characterize mucoadhesive buccal tablets of aceclofenac, utilizing different proportions of three polymers carbopol 934, hydroxypropyl methylcellulose, and sodium carboxymethylcellulose. Twelve batches of buccoadhesive aceclofenac were prepared by the direct compression method. The compressed tablets were then evaluated for physicochemical parameters such as hardness, thickness, weight variation, drug content, friability, swelling index, surface pH, and ex vivo mucoadhesion. In vitro dissolution test was conducted for 12 h according to Indian Pharmacopeia 2018, using the rotating paddle method in phosphate buffer of pH 7.4. Physiochemical parameters like weight variation (231.25–268.75 mg), hardness (8.32–11.56 kg), friability (0.04–0.2%), diameter (9.00 mm), thickness (3.8–4.05 mm), and drug content ((97.67–102.25%) were within the acceptable limit as per Indian Pharmacopeia 2018. The swelling index was reported to be in the range of 112.93–450.19%, at 8 h. The surface pHs of all the batches were in between 6.72 to 6.96. The mucoadhesive strengths (40.5–50 g) varied with the change in polymer concentrations especially of carbopol 934. The dissolution profile of all the batches varied greatly, with a maximum release of 109.41% (in batch 12 at 6 h) to a minimum release of 44.82% (in batch 3 at 12 h). Among them, only batch 1 ensured sustained and effective drug release (88.34% at 12 h) with appropriate swelling index (112.93%) and mucoadhesive strength (40 g). Fourier Transform Infrared Spectroscopy analysis showed no evidence of drug excipients interaction. Hence, the results concluded that buccal mucoadhesive aceclofenac tablets can be formulated. Furthermore, the property of the tablet not only depends on the concentration but also the behavior of the polymers used.