Podophyllin Peltatum USP

Podophyllum Peltatum
Podophyllum Resin USP

Written by

Reviewed by

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Gaurav Sood

Partner - HimPharm

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Dr B M Sood

Chairman - HimPharm

Podophyllum Resin USP by HimPharm

Category: Phytochemical
Trade Names: Pod-Ben-25, Podophyllin
Routes of Administration: Topical
ATC Code: D06BB02

Identifiers

  • CAS Number: 8023-77-6
  • PubChem CID: 199956
  • ChemSpider ID: 173073

Chemical and Physical Data

  • Molecular Formula C22H22O8
    Molar Mass 414.40 g/mol

SMILES: CC1=C(C2=C(C=C1O)C(=CC(=O)C2=O)OC3=CC (=C(C=C3)O)OC4C(C(C(C(O4)CO)O)O)O)O

InChI: InChI=1S/C21H20O6/c1-26-20-11-14(5-9-18(20)23)3-7-16(25)13-15(4-8-17(13)20)6-10-19(24)21(22)12-27-2/h3-12,22-24H,1-2H3/b7-3+,8-4+

Introduction

Podophyllum Resin USP

Podophyllum Resin USP, commonly known as mayapple, is a vital natural resource serving as the starting material for the semi-synthesis of anti-cancer drugs such as etoposide, teniposide, and etopophos. Derived from the North American variety of Podophyllum, this compound has played a pivotal role in the treatment of lung and testicular cancers, as well as certain leukemias. 

Additionally, it serves as a precursor to CPH 82, a derivative under evaluation for rheumatoid arthritis in Europe, and finds applications in the treatment of psoriasis and malaria. Beyond its pharmaceutical significance, Podophyllum Peltatum USP is also recognized as an effective remedy for warts, particularly those associated with certain viral infections.

Podophyllin Peltatum USP

Impact of Podophyllum Resin USP on Pharmaceutical, Drug, and Natural Products Industry

The impact of Podophyllum Resin USP on the pharmaceutical, drug, and natural products industry cannot be overstated. As the fundamental ingredient in the synthesis of anti-cancer drugs, this compound has revolutionized cancer treatment, offering hope and efficacy in the face of challenging diseases. Its diverse applications extend to rheumatoid arthritis, psoriasis, malaria, and wart treatments. 

The compound’s inclusion in the World Health Organization’s List of Essential Medicines underscores its global importance in healthcare. HimPharm, with its commitment to manufacturing Podophyllum Peltatum USP in adherence to United States Pharmacopoeia standards, stands as a key player in fulfilling bulk requirements for pharmaceutical and industrial consumers.

Understanding Podophyllum Peltatum USP

What is Podophyllum Resin USP?

Podophyllum Resin USP, also known as mayapple or Podophyllum Resin USP, is a resin derived from the roots of the North American mandrake plant. It serves as a crucial starting material for the synthesis of various pharmaceutical compounds, particularly anti-cancer drugs and treatments for dermatological conditions like warts. 

The compound owes its therapeutic properties primarily to podophyllotoxin, a bioactive compound that inhibits cell division, making it effective against rapidly dividing cells characteristic of cancerous growths and certain viral infections.

Uses of Podophyllum Peltatum USP

Podophyllum Peltatum USP finds extensive use in oncology for the treatment of lung and testicular cancers, as well as certain forms of leukemia. Its efficacy stems from its ability to inhibit cell division and induce apoptosis (programmed cell death) in cancer cells, thereby impeding tumor growth and progression. Additionally, the compound has demonstrated promising results in the management of dermatological conditions such as psoriasis and the treatment of malaria.

Physical Characteristics of Podophyllum Peltatum USP

Podophyllin resin USP typically presents as a resinous substance, ranging in color from pale yellow to brown. Its consistency may vary from viscous to semi-solid, depending on factors such as temperature and processing methods. The resin possesses a distinct aromatic odor and a bitter taste, characteristics that distinguish it from other plant-derived compounds.

Extraction and Processing of Podophyllum Peltatum USP

The extraction of Podophyllum Peltatum USP involves harvesting the roots of the mayapple plant and subjecting them to solvent-based extraction techniques. This process yields a crude extract rich in podophyllotoxin, which undergoes purification to isolate the desired compound. The purified resin is then standardized according to United States Pharmacopoeia standards to ensure consistency and potency across batches.

Significance of Podophyllum Peltatum USP

Podophyllum Peltatum USP holds significant therapeutic value in the field of oncology and dermatology, offering effective treatment options for a range of conditions. Its inclusion in the semi-synthesis of anti-cancer drugs underscores its importance as a precursor compound in pharmaceutical manufacturing. Moreover, its historical use as a wart remedy highlights its enduring relevance in traditional medicine and modern healthcare practices.

Historical Background of Podophyllum Peltatum USP

  1. Discovery Location: The mayapple plant, from which Podophyllum Peltatum USP is derived, is native to North America, particularly regions of the United States and Canada.
  2. Discoverer: The medicinal properties of mayapple root were recognized by indigenous peoples long before the advent of modern medicine. However, the compound’s isolation and scientific exploration can be attributed to early pharmacognosists and botanists.
  3. Story Behind its Discovery: The discovery of Podophyllum Peltatum USP’s therapeutic properties is rooted in the traditional knowledge of Native American tribes, who utilized the plant for various medicinal purposes, including the treatment of skin ailments and cancerous growths.
  4. Development Landmarks: Over the years, advancements in pharmaceutical research and manufacturing have led to the elucidation of Podophyllum Peltatum USP’s molecular mechanisms and therapeutic potential. Its journey from traditional remedy to essential pharmaceutical ingredient highlights the intersection of traditional medicine and modern science in the pursuit of better healthcare solutions.

Exploring Podophyllum Peltatum USP and its Use in Pharmaceuticals, Health, and Drug Industry

Properties and Uses of Podophyllum Peltatum USP

Podophyllum Peltatum USP exhibits several pharmacological properties that make it a valuable therapeutic agent in various medical contexts. Its primary active constituent, podophyllotoxin, acts as a cytotoxic agent by interfering with microtubule assembly, thereby arresting cell division and inducing cell death in rapidly proliferating cells. This mechanism underlies its efficacy in cancer therapy, where it targets malignant cells while sparing healthy tissues.

In addition to its anti-cancer properties, Podophyllin Peltatum USP possesses antiviral and anti-inflammatory activities, making it useful in the treatment of viral infections and inflammatory dermatoses. Its broad-spectrum pharmacological profile renders it applicable in diverse therapeutic areas, ranging from oncology to dermatology and infectious diseases.

Detailed Uses and Action Mechanisms

  • Oncology: In oncology, Podophyllum Peltatum USP serves as a precursor in the synthesis of topoisomerase II inhibitors, including etoposide and teniposide. These drugs exert their anti-cancer effects by inhibiting topoisomerase II, an enzyme crucial for DNA replication and repair. By interfering with DNA synthesis and inducing DNA strand breaks, these agents impede tumor growth and proliferation, making them vital components of chemotherapy regimens for various malignancies.
  • Dermatology: The antiviral and keratolytic properties of Podophyllum Peltatum USP render it effective in the treatment of cutaneous warts caused by human papillomavirus (HPV) infection. Topical application of podophyllotoxin-containing formulations leads to the destruction of wart tissue by disrupting viral replication and promoting tissue necrosis. This targeted approach minimizes damage to surrounding healthy skin and facilitates wart resolution without scarring.
  • Infectious Diseases: Podophyllum Peltatum USP’s broad-spectrum antiviral activity extends to the management of other viral infections, including herpes simplex virus (HSV) and molluscum contagiosum. By inhibiting viral DNA synthesis and viral protein expression, podophyllotoxin-containing preparations mitigate viral replication and alleviate symptoms associated with these infections.

Additional Properties and Alternative Uses

Beyond its therapeutic applications, Podophyllum Peltatum USP possesses ancillary properties that augment its utility in pharmaceutical formulations. Its solubility in organic solvents facilitates its incorporation into various dosage forms, including topical solutions, ointments, and gels. Furthermore, its stability under storage conditions ensures product integrity and shelf-life, enhancing the reliability of formulations containing Podophyllum Peltatum USP.

Alternative uses of Podophyllum Peltatum USP include its potential role as an adjuvant therapy in autoimmune and inflammatory conditions, where its immunomodulatory effects may confer therapeutic benefits. Preclinical studies investigating its anti-inflammatory properties have yielded promising results, suggesting its potential application in conditions such as rheumatoid arthritis and psoriasis.

The Raw Material for Podophyllum Peltatum USP: Natural Source and Alternative Extraction Methods

Raw Material Overview

The primary source of Podophyllum Peltatum USP is the roots of the North American mayapple plant, scientifically known as Podophyllum peltatum. Indigenous to forested regions of North America, including parts of the United States and Canada, the mayapple plant harbors bioactive compounds, particularly podophyllotoxin, within its rhizomes. These rhizomes serve as the reservoir for Podophyllum Peltatum USP, providing the raw material for its extraction and purification.

The botanical name of the mayapple plant, Podophyllum peltatum, reflects its taxonomic classification within the genus Podophyllum and the species peltatum. This botanical nomenclature underscores its association with other Podophyllum species known for their medicinal properties and chemical constituents.

Alternative Sources and Extraction Methods

While the North American mayapple plant remains the primary source of Podophyllum Peltatum USP, efforts have been made to explore alternative botanical sources and extraction techniques to meet growing demand and ensure sustainability. Several related species within the genus Podophyllum, such as Podophyllum hexandrum and Podophyllum emodi, contain podophyllotoxin in varying concentrations and have been investigated as potential sources of the compound.

Additionally, advancements in biotechnology and plant tissue culture have enabled the production of podophyllotoxin through in vitro cultivation of plant cells and tissues. This alternative approach offers the prospect of sustainable podophyllotoxin production without the need for extensive cultivation of wild plant populations, thereby mitigating ecological concerns associated with overharvesting.

Exploration of novel extraction methods, including supercritical fluid extraction and microwave-assisted extraction, has also contributed to the diversification of Podophyllum Peltatum USP production. These techniques offer advantages such as reduced solvent usage, enhanced extraction efficiency, and shorter processing times, making them environmentally friendly and economically viable alternatives to conventional extraction methods.

HimPharm's Manufacturing Standards for Podophyllum Peltatum USP

HimPharm’s Role in Podophyllum Peltatum USP Production

HimPharm stands as a pioneer in the production of Podophyllum Peltatum USP, leveraging decades of experience and expertise in pharmaceutical manufacturing. With roots dating back to 1979, HimPharm has established itself as a leading provider of high-quality botanical extracts and active pharmaceutical ingredients (APIs), including Podophyllum Peltatum USP.

At the heart of HimPharm’s manufacturing ethos lies a commitment to excellence and innovation. The company’s state-of-the-art facilities and advanced technologies enable the efficient extraction, purification, and standardization of Podophyllum Peltatum USP, ensuring consistency and potency across batches.

Upholding International Quality Standards

HimPharm places utmost importance on upholding international quality standards throughout the manufacturing process. Adherence to stringent quality control measures and regulatory requirements is ingrained in every aspect of production, from raw material procurement to final product formulation.

The company’s quality assurance team comprises seasoned professionals equipped with the latest analytical tools and techniques to monitor product quality at every stage. Rigorous testing protocols ensure the purity, potency, and safety of Podophyllum Peltatum USP, meeting or exceeding global pharmacopoeial standards.

HimPharm’s Commitment to Fulfilling Bulk Requirements

HimPharm’s modern manufacturing facility is designed to accommodate bulk production requirements, catering to the diverse needs of pharmaceutical companies, drug manufacturers, and industrial consumers worldwide. Whether sourcing Podophyllum Peltatum USP for drug formulation or research purposes, clients can rely on HimPharm to deliver high-quality products in quantities tailored to their specifications.

The company’s flexible production capabilities enable seamless scalability, allowing for the production of small pilot batches to large-scale commercial quantities. HimPharm’s commitment to meeting client demands with precision and efficiency underscores its position as a trusted partner in the pharmaceutical supply chain.

Production Processes of Podophyllum Peltatum USP

Step-by-Step Manufacturing Process

The production of Podophyllum Peltatum USP at HimPharm unfolds through a meticulously orchestrated series of steps, each aimed at ensuring the purity, potency, and safety of the final product. The manufacturing process involves the following key stages:

  1. Raw Material Procurement: HimPharm sources high-quality rhizomes of Podophyllum peltatum from reputable suppliers, ensuring the selection of plant material rich in podophyllotoxin, the primary active constituent.
  2. Extraction: The rhizomes undergo extraction using solvent-based techniques to isolate podophyllotoxin and other bioactive compounds. Ethanol, methanol, or a combination of solvents may be employed to achieve optimal extraction efficiency.
  3. Purification: The crude extract undergoes purification to remove impurities, plant debris, and undesirable components. Filtration, chromatography, and precipitation techniques are employed to achieve high levels of purity.
  4. Concentration: The purified extract is concentrated to enhance the concentration of podophyllotoxin, thereby maximizing its therapeutic efficacy. Vacuum distillation or evaporation techniques may be utilized to remove excess solvent and concentrate the active constituents.
  5. Quality Control Testing: Throughout the manufacturing process, rigorous quality control testing is conducted to assess the identity, purity, and potency of Podophyllum Peltatum USP. Analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry are employed to ensure compliance with pharmacopoeial standards.
  6. Packaging and Labeling: Upon successful completion of quality control testing, the finalized product is packaged and labeled according to regulatory requirements. Tamper-evident seals, batch numbers, and expiration dates are included to facilitate product traceability and consumer safety.

Ensuring Quality: Testing Procedures in Podophyllum Peltatum USP Manufacturing

Quality control serves as a cornerstone of HimPharm’s manufacturing process, with comprehensive testing procedures implemented to uphold product integrity and meet regulatory standards. The following testing protocols are routinely conducted:

  • Identity Testing: Verification of the botanical identity and authenticity of raw materials through macroscopic and microscopic examination, ensuring compliance with established specifications.
  • Purity Analysis: Assessment of the purity of Podophyllum Peltatum USP through chemical analysis, including determination of impurities, heavy metals, and residual solvents.
  • Potency Assay: Quantification of podophyllotoxin content using validated analytical methods, ensuring consistency and potency across batches.
  • Microbiological Testing: Screening for microbial contaminants, including bacteria, fungi, and molds, to ensure product safety and sterility.
  • Stability Testing: Evaluation of the stability of Podophyllum Peltatum USP under various storage conditions, including temperature, humidity, and light exposure, to determine shelf-life and product efficacy.

By adhering to stringent testing protocols and quality assurance measures, HimPharm ensures that Podophyllum Peltatum USP meets the highest standards of quality, safety, and efficacy.

In the subsequent sections, we will explore the challenges and bottlenecks inherent in Podophyllum Peltatum USP manufacturing and how HimPharm navigates these obstacles to deliver superior products to its clients.

Navigating Production Bottlenecks in Podophyllum Peltatum USP Manufacturing

The dynamic landscape of pharmaceutical manufacturing presents inherent challenges and bottlenecks that require proactive management and innovative solutions. HimPharm remains vigilant in identifying and addressing potential obstacles to ensure seamless production of Podophyllum Peltatum USP. Some of the key bottlenecks and strategies for overcoming them include:

  1. Raw Material Sourcing: Ensuring a consistent and reliable supply of high-quality rhizomes of Podophyllum peltatum is essential for uninterrupted manufacturing. HimPharm maintains robust supplier relationships and conducts stringent quality checks to mitigate the risk of raw material shortages or inconsistencies.
  2. Process Optimization: Streamlining manufacturing processes to enhance efficiency and throughput is crucial for meeting production targets and reducing lead times. HimPharm invests in research and development initiatives to optimize extraction, purification, and formulation techniques, thereby increasing productivity and minimizing production cycle times.
  3. Regulatory Compliance: Navigating complex regulatory requirements and ensuring adherence to international quality standards are vary important for securing regulatory approval and market access. HimPharm maintains a dedicated regulatory affairs team tasked with staying abreast of evolving regulations and implementing best practices to ensure compliance with global pharmaceutical standards.
  4. Supply Chain Logistics: Managing logistics and distribution channels to minimize transit times and ensure timely delivery of finished products is essential for meeting customer demand and maintaining market competitiveness. HimPharm leverages advanced supply chain management systems and strategic partnerships with logistics providers to optimize inventory management and streamline distribution processes.

HimPharm’s proactive approach to identifying and addressing production bottlenecks underscores its commitment to operational excellence and customer satisfaction. By implementing innovative solutions and strategic initiatives, HimPharm ensures the uninterrupted supply of high-quality Podophyllum Peltatum USP to its clients worldwide.

HimPharm’s Manufacturing Advantage

HimPharm’s manufacturing advantage lies in its unwavering commitment to excellence, innovation, and customer-centricity. With a legacy of over four decades in the pharmaceutical industry, HimPharm has earned a reputation for delivering superior products and services. Some key aspects of HimPharm’s manufacturing advantage include:

  • State-of-the-Art Infrastructure: HimPharm’s modern manufacturing facilities are equipped with advanced technology and state-of-the-art equipment, enabling the production of high-quality Podophyllum Peltatum USP at scale.
  • Experienced Team: HimPharm boasts a team of seasoned professionals with expertise in pharmaceutical manufacturing, quality assurance, and regulatory compliance. Their collective knowledge and experience drive continuous improvement and innovation across all aspects of production.
  • Quality Assurance: HimPharm places a premium on product quality and safety, with stringent quality control measures implemented at every stage of the manufacturing process. From raw material procurement to final product release, HimPharm adheres to international quality standards and regulatory requirements.
  • Scalability and Flexibility: HimPharm’s manufacturing capabilities are designed to accommodate varying production requirements, from small-scale pilot batches to large-scale commercial production. This scalability and flexibility enable HimPharm to meet the diverse needs of its clients with precision and efficiency.
Podophyllum Peltatum
Podophyllum Peltatum

Conclusion

In conclusion, the journey of Podophyllum Peltatum USP from raw material to finished product exemplifies HimPharm’s dedication to excellence, innovation, and customer satisfaction. 

Through meticulous manufacturing processes, stringent quality control measures, and proactive management of production bottlenecks, HimPharm ensures the delivery of high-quality Podophyllum Peltatum USP to pharmaceutical companies, drug manufacturers, and industrial consumers worldwide.

Recap of Key Insights

Throughout this article, we have looked into the intricacies of Podophyllum Peltatum USP, exploring its origins, production processes, and applications in pharmaceutical and healthcare industries. From its discovery as a potent botanical extract to its role as a key ingredient in anti-cancer drugs and wart treatments, Podophyllum Peltatum USP has carved a niche for itself in modern medicine.

We have examined HimPharm’s pivotal role in the production of Podophyllum Peltatum USP, highlighting the company’s commitment to upholding international quality standards, fulfilling bulk requirements, and overcoming production challenges. With decades of experience, state-of-the-art infrastructure, and a dedicated team of professionals, HimPharm stands as a trusted partner in the pharmaceutical supply chain, offering excellence in every aspect of manufacturing.

Leveraging HimPharm’s Commitment to Quality

As pharmaceutical companies, drug manufacturers, and industrial consumers seek reliable sources of high-quality botanical extracts and active pharmaceutical ingredients, HimPharm emerges as a beacon of excellence and innovation. By leveraging HimPharm’s manufacturing expertise, clients can rest assured of receiving superior products tailored to their specifications, backed by unparalleled customer support and service.

HimPharm’s commitment to quality, integrity, and continuous improvement underscores its position as a leader in the pharmaceutical industry, driving innovation and progress in healthcare worldwide. As the demand for plant-based medicines and natural healthcare solutions continues to rise, HimPharm remains steadfast in its mission to deliver excellence in every product and service it offers.

In closing, we invite pharmaceutical companies, drug manufacturers, and industrial consumers to partner with HimPharm and experience the difference in quality, reliability, and innovation that sets us apart. Together, we can shape the future of healthcare and contribute to a healthier, more sustainable world.

Through collaborative partnerships and a shared commitment to excellence, we can harness the power of nature to transform lives and advance the frontiers of medicine. HimPharm stands ready to embark on this journey with you, delivering quality, integrity, and innovation every step of the way.

Write to or Call HimPharm to Request a Quote, COA, and MSDS.

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