Hydroxypropyl-Beta-Cydodextrin 128446-35-5 Manufacturer Exporter MEDIOCON INC

 

 

Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC     

 

   Name: Hydroxypropyl-Beta-Cydodextrin

CAS No:  128446-35-5

Molecular Weight: 1400 to 1550 g/mol

Molecular formula:   NA

Synonyms:  hydroxypropylbetadex, HPbCD, HP-β-CD, 2-hydroxypropyl-β-cyclodextrin

 Appearance:   white to off-white powder, sometimes described as white or almost white, which can also be amorphous or crystalline.

 Solubility :  highly soluble in water.

Use :

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is a derivative of beta-cyclodextrin, widely used in pharmaceuticals, cosmetics, and food industries due to its excellent solubilizing and stabilizing properties.

Applications:

1. Pharmaceuticals: Enhances solubility and bioavailability of poorly soluble drugs.

2. Cosmetics: Improves stability and delivery of active ingredients.

3. Food: Encapsulates flavors, colors, and nutrients.

Suppliers in India:

1. Ashland India Pvt. Ltd.

2. Ashahi Kasei Chemicals

3. Roquette India Pvt. Ltd.

4. Sigma-Aldrich India

5. Cyclolab Ltd. (with presence in India)

 

 

 How is  Hydroxypropyl-Beta-Cydodextrin manufactured by MEDIOCON INC Synthesized?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is synthesized through a chemical modification of beta-cyclodextrin (β-CD). The process involves the reaction of β-CD with propylene oxide in an alkaline medium. Here's a brief overview of the synthesis steps:

 

1. Starting Material: Beta-cyclodextrin (β-CD) is obtained from starch through enzymatic hydrolysis using cyclodextrin glucanotransferase.

2. Alkalization: β-CD is treated with a strong base like sodium hydroxide (NaOH) to activate the hydroxyl groups.

3. Etherification: Propylene oxide is added to the alkalized β-CD, leading to the hydroxypropylation of the hydroxyl groups. This reaction introduces hydroxypropyl groups (-CH2CH(OH)CH3) onto the β-CD molecule.

4. Purification: The reaction mixture is neutralized and purified through ultrafiltration, diafiltration, or precipitation to remove unreacted reagents and by-products.

5. Drying: The purified HP-β-CD is then dried to obtain a white, amorphous powder.

 

The degree of substitution (DS) and molar substitution (MS) can be controlled by adjusting the reaction conditions, such as the amount of propylene oxide and the reaction time. HP-β-CD is widely used in pharmaceuticals, cosmetics, and food industries due to its excellent solubilizing and stabilizing properties .

What are the different  dosage forms  of   Hydroxypropyl-Beta-Cydodextrin Manufactured  by  MEDIOCON INC?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is a versatile excipient used in various dosage forms to enhance solubility, stability, and bioavailability of drugs. Here are the different dosage forms of HP-β-CD¹ ²:

- Injectable Formulations: HP-β-CD is used in injectable drugs to improve solubility and reduce irritation, particularly for poorly water-soluble active ingredients.

- Oral Tablets and Capsules: It enhances bioavailability and stability of drugs, masking unpleasant tastes and odors. Roquette's KLEPTOSE HP Oral grade HP-β-CD is specifically designed for oral dosage forms.

- Eye Drops: HP-β-CD is used in ophthalmic solutions to solubilize and stabilize active ingredients, ensuring effective delivery.

- Topical Creams and Gels: It improves solubility and stability of active ingredients in topical formulations, enhancing skin penetration and efficacy.

- Inhalation Products: HP-β-CD is used in inhalable formulations to improve solubility and bioavailability of drugs, particularly for respiratory conditions.

- Powders and Aqueous Sprays: HP-β-CD can convert liquid active ingredients into stable powders or aqueous sprays, enhancing formulation flexibility.

 

These dosage forms leverage HP-β-CD's ability to form inclusion complexes with drug molecules, improving their solubility, stability, and absorption.

 How Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) dosage forms are prepared using various methods depending on the desired formulation. Here's an overview of the preparation process for different dosage forms:

 

Injectable Formulations

 

- HP-β-CD is dissolved in water, and the active pharmaceutical ingredient (API) is added to the solution.

- The mixture is then sterilized by filtration or autoclaving.

- The solution is filled into vials or ampoules and sealed.¹

 

Oral Tablets and Capsules

 

- HP-β-CD is mixed with the API and other excipients, such as binders and fillers.

- The mixture is granulated using a fluid bed granulator or a high-shear granulator.

- The granules are then compressed into tablets or filled into capsules.²

 

Oral Solutions

 

- HP-β-CD is dissolved in water, and the API is added to the solution.

- The mixture is then stirred and heated to ensure complete dissolution.

- Other excipients, such as preservatives and flavorings, are added to the solution.³

 

Topical Creams and Gels

 

- HP-β-CD is dissolved in a solvent, such as water or ethanol, and the API is added to the solution.

- The mixture is then mixed with other excipients, such as emollients and thickeners.

- The mixture is then filled into tubes or jars and sealed.

 

The preparation of HP-β-CD dosage forms requires careful consideration of factors such as the molar substitution (MS) of HP-β-CD, the degree of substitution (DS), and the molecular weight of the polymer. These factors can affect the solubility, stability, and bioavailability of the API.

What are the appropriate Dosage forms of Hydroxypropyl-Beta-Cydodextrin Manufactured  by  MEDIOCON   INC?                

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is a versatile excipient used in various dosage forms to enhance solubility, stability, and bioavailability of drugs. Here are some appropriate dosage forms of HP-β-CD¹ ² ³:

- Injectables: HP-β-CD is used in injectable drugs to improve solubility and reduce irritation, particularly for poorly water-soluble active ingredients. KLEPTOSE HPB Biopharma grade is a low-endotoxin, pyrogen-free solution for protein stabilization in biopharmaceutical downstream applications.

- Oral Tablets and Capsules: HP-β-CD enhances bioavailability and stability of drugs, masking unpleasant tastes and odors. Roquette's KLEPTOSE HP Oral grade HP-β-CD is specifically designed for oral dosage forms, suitable for swallowable tablets, chewable tablets, effervescent tablets, and hard capsules.

- Eye Drops: HP-β-CD is used in ophthalmic solutions to solubilize and stabilize active ingredients, ensuring effective delivery.

- Topical Creams and Gels: It improves solubility and stability of active ingredients in topical formulations, enhancing skin penetration and efficacy.

- Inhalation Products: HP-β-CD is used in inhalable formulations to improve solubility and bioavailability of drugs, particularly for respiratory conditions.

- Oral Solutions: HP-β-CD can be used to prepare oral solutions, enhancing solubility and stability of poorly water-soluble drugs.

When should Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC be taken?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is typically taken orally, and the timing depends on the specific medication or supplement it is part of. Here are some general guidelines:

- With or without food: HP-β-CD can be taken with or without food, depending on the formulation and individual tolerance.

- As directed by a healthcare professional: Follow the dosage and administration instructions provided by your healthcare provider or pharmacist.

- Consistency is key: Take HP-β-CD at the same time every day to maintain consistent levels in the body.

- Specific timing for certain conditions: For example, if HP-β-CD is part of a medication for digestive issues, it may be taken before meals to help manage symptoms.

 

Some popular brand names that use HP-β-CD include:

- Trappsol Cyclo: Used for Niemann-Pick Disease Type C1.

- Kleptose HPB: Used as an excipient in various pharmaceutical formulations.

 What are the effects And Side effects of Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is a versatile excipient used in various pharmaceutical formulations to enhance solubility, stability, and bioavailability of drugs. Let's break down its effects and side effects:

 

Benefits:

 

- Enhanced Solubility: HP-β-CD forms inclusion complexes with hydrophobic drugs, improving their solubility and absorption.

- Reduced Irritation: It helps minimize irritation caused by certain active ingredients.

- Improved Stability: HP-β-CD stabilizes formulations, extending shelf life and ensuring consistent efficacy.

- Safe Profile: Generally considered safe and well-tolerated in various dosage forms.¹

 

Side Effects:

 

- Mild Gastrointestinal Discomfort: Nausea, vomiting, indigestion, diarrhea, and heartburn may occur.

- Headache: Some individuals might experience headaches.

- Skin Irritation: Topical applications can cause redness, itching, swelling, dryness, or rash.

- Allergic Reactions: Rare cases of allergic reactions have been reported.

- Kidney Impact: High doses or long-term use may potentially affect kidney function.

- Hearing Loss: Systemic and intra cerebro ventricular delivery of HP-β-CD has been associated with hearing loss in some cases.² ³

Special Considerations:

- Pregnancy and Breastfeeding: Consult a healthcare provider before using products containing HP-β-CD.

- Kidney Issues: Inform your doctor about any pre-existing kidney conditions.

- Long-term Use: Regular monitoring of kidney function and blood components is recommended.⁴

Keep in mind that adverse reactions to HP-β-CD are rare, and most people tolerate it well. If you experience any side effects, discontinue use and consult a healthcare professional.

  How is Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON  INC  Tested Qualitatively?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is tested qualitatively using various methods, including:

 

1. High-Performance Liquid Chromatography (HPLC): This method involves detecting impurities like beta-cyclodextrin (β-CD) and 1,2-propylene glycol (1,2-PD) using a phenyl silane bonded silica gel column with acetonitrile-water as the mobile phase and a differential refraction detector. HPLC helps determine the content of β-CD, 1,2-PD, and 1,2-PD polymer in HP-β-CD.¹

 

2. Liquid Chromatography-Mass Spectrometry (LC-MS): This technique qualitatively evaluates HP-β-CD polydispersity and detects unknown impurities. LC-MS provides a polydispersity fingerprint, reflecting the diversity of substituted β-CD species and their stability.

 

3. Nuclear Magnetic Resonance (NMR) Spectroscopy: NMR determines the molar substitution (MS) of HP-β-CD by measuring the number of hydroxypropyl groups per glucose unit. This method uses a Fourier-transform NMR spectrometer with a magnetic field strength of at least 6 Tesla.² ³

4. Infrared Absorption Spectroscopy: This method identifies HP-β-CD through its characteristic absorption bands, similar to USP Hydroxypropyl Betadex RS.

5. Thin-Layer Chromatography (TLC): TLC is used to identify β-CD in HP-β-CD, where the test solution and standard solution of USP Beta Cyclodextrin RS are applied to a plate, and the retention factor is compared.

These qualitative testing methods ensure the identification, purity, and quality of HP-β-CD, a crucial excipient in pharmaceutical formulations.

   Which tests are performed on Hydroxypropyl-Beta-Cydodextrin Manufactured by  MEDIOCON INC ?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) undergoes various tests to ensure its quality and purity. These tests include¹ ²:

- Identification Test: Infrared Absorption Spectroscopy (IR) is used to identify HP-β-CD, which shows the same absorption bands as the spectrum acquired with USP Hydroxypropyl Betadex RS.

- Clarity of Solution Test: A solution of 1.0 g HP-β-CD in 2.0 mL of water is heated and then cooled to room temperature. The resulting solution should be clear and remain transparent.

- Microbial Limits Test: The total aerobic microbial count should not exceed 1000 cfu/g, and the total combined molds and yeasts count should not exceed 100 cfu/g.

- Heavy Metals Test: The limit of heavy metals is not more than 20 µg/g.

- Loss on Drying Test: HP-β-CD is dried at 120°C for 2 hours, and the weight loss should not exceed 10.0%.

- Conductivity Test: The conductivity of a 5.0 g HP-β-CD solution in 50 mL of water should not exceed 200 µS·cm^-1.

- Bacterial Endotoxins Test: The level of bacterial endotoxins should meet the requirements of the relevant dosage form monograph.

- Molar Substitution Test: Nuclear Magnetic Resonance (NMR) Spectroscopy is used to determine the molar substitution of HP-β-CD.

- Limit of Propylene Oxide Test: Gas Chromatography (GC) is used to detect the presence of propylene oxide, with a limit of 0.0001%.

- High-Performance Liquid Chromatography (HPLC) Test: HPLC is used to detect impurities like beta-cyclodextrin and 1,2-propylene glycol, with a limit of 1.5% for beta-cyclodextrin and 1% for propylene glycol.

- Liquid Chromatography-Mass Spectrometry (LC-MS) Test: LC-MS is used to qualitatively evaluate HP-β-CD polydispersity and detect unknown impurities.

What are the challenges in Manufacturing of Banana ExtractManufactured by MEDIOCON   INC API?

Manufacturing banana extract API faces several challenges that impact its efficiency, quality, and market viability. Here are some key hurdles:

 

Raw Material Availability and Cost

 

Banana plants are primarily grown for fruit production, limiting the supply of raw materials for extract manufacturing. This scarcity can lead to fluctuations in availability and pricing, making it difficult for manufacturers to secure a consistent supply at a reasonable cost.¹ ²

 

Extraction and Processing Challenges

 

- Labor-Intensive Extraction: Manual stripping of outer layers and fiber separation is time-consuming and prone to inconsistencies in quality.

- Technical Difficulties: Decortication and cleaning require specialized equipment, increasing production costs.

- Variability in Harvesting and Processing: Inconsistent fiber quality affects suitability for various applications, limiting competitiveness against other natural fibers.

 

Quality Control and Standardization

 

Ensuring consistent quality of banana extract API is crucial. However, differences in extraction techniques and processing methods can lead to variability in product quality.³

 

Environmental Concerns

 

Chemical treatments used in extraction and processing can generate waste, necessitating careful management to minimize pollution. Developing eco-friendly processing methods is essential for sustainability.

 

Market Perception and Adoption

 

Banana extract API products are still relatively niche, requiring consumer education to promote awareness and adoption. Market perception and demand play a significant role in determining the viability of banana extract API manufacturing.

Regulatory Compliance

Manufacturers must comply with regulatory requirements, ensuring the extract meets quality and safety standards for various applications, including pharmaceuticals and food products.

Addressing these challenges is crucial for the successful manufacturing of banana extract API. By developing efficient extraction techniques, ensuring quality control, and promoting market adoption, manufacturers can overcome these hurdles and capitalize on the potential of banana extract API.

What are the challenges in manufacturing of Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON  INC ’s Dosage forms?

Manufacturing Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) dosage forms poses several challenges that can impact the efficiency, quality, and market viability of the final product.

 

Raw Material and Formulation Challenges

 

- Solubility and Bioavailability Issues: HP-β-CD's ability to form inclusion complexes with hydrophobic drugs can be affected by factors like pH, temperature, and presence of other excipients, leading to variability in solubility and bioavailability.

- Variability in Raw Materials: Differences in quality, purity, or source of HP-β-CD can impact its functionality and performance in formulations.¹ ²

 

Manufacturing Process Challenges

 

- Stickiness and Handling Issues: HP-β-CD's hygroscopic nature can cause stickiness during processing, affecting tablet compression, capsule filling, and other manufacturing steps.

- Moisture Control: Controlling moisture levels is crucial to prevent degradation, aggregation, or instability of HP-β-CD and APIs.

- Equipment Compatibility: Ensuring compatibility between HP-β-CD and manufacturing equipment is essential to prevent issues like clogging, wear, or contamination.

 

Quality Control and Regulatory Challenges

 

- Complex Analytical Methods: Developing and validating analytical methods for HP-β-CD and API quantification can be complex due to the polymeric nature of HP-β-CD.

- Regulatory Compliance: Meeting regulatory requirements for HP-β-CD dosage forms demands extensive documentation, testing, and validation.

- Batch-to-Batch Consistency: Ensuring consistent quality across batches is crucial, requiring robust quality control measures.³ ⁴

 

Patient-Centric Challenges

 

- Dose Uniformity: Achieving uniform dosing in HP-β-CD formulations can be challenging due to variability in API content or HP-β-CD substitution degrees.

- Taste Masking: HP-β-CD's potential bitter taste or unpleasant odor may require additional taste-masking measures.

- Patient Compliance: Ensuring patient compliance with HP-β-CD dosage forms, particularly for pediatric or geriatric populations, demands careful consideration of dosage form design and patient-centric factors.⁵

Addressing these challenges requires a deep understanding of HP-β-CD's properties, formulation strategies, and manufacturing processes. By leveraging advances in technology, analytics, and quality control, manufacturers can overcome these hurdles and develop high-quality HP-β-CD dosage forms.

What is the Packing for Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC?

Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) is typically packaged in various sizes to cater to different needs. Here are some common packaging options:

- Small quantities: 5 gm, 25 gm, 100 gm, and 500 gm bottles or packets, ideal for laboratory or research purposes.

- Medium quantities: 1 kg or 5 kg bags or fiber drums, suitable for small-scale industrial or pharmaceutical applications.

- Large quantities: 20 kg drums or cardboard boxes, often used for commercial-scale manufacturing of pharmaceuticals, cosmetics, or food products.¹ ² ³

The packaging material and type may vary depending on the supplier, product specifications, and intended use. It's essential to check with the manufacturer or supplier for specific packaging options and details. Additionally, HP-β-CD should be stored in well-closed containers at room temperature to maintain its quality and stability.

What is shelf life Of Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC? 

The shelf life of Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) varies depending on the manufacturer, storage conditions, and specific product grade. Here are some general guidelines:

- Typical Shelf Life: 24-36 months when stored in well-closed containers at room temperature.

- Pharmaceutical Grade: CAVASOL W7 HP PHARMA, a pharmaceutical-grade HP-β-CD from Wacker Chemie AG, has a shelf life of at least 36 months when stored in unbroken original packaging in dry storage areas.

- Storage Conditions: Room temperature, in tightly closed containers, and dry conditions are recommended to maintain stability.

- Manufacturer-Specific: Loba Chemie reports a shelf life of 36 months for their HP-β-CD product, while Accela Chembio Inc specifies 1440 days (approximately 4 years) for their product.¹ ² ³

 

It's essential to check the specific product label or consult with the manufacturer for the most accurate shelf life information. Proper storage conditions and handling practices will also help ensure the product remains usable beyond its specified shelf life.

What should the label claim for Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC   Include?

The label claim for Hydroxypropyl-Beta-Cyclodextrin (HP-β-CD) should include the following information¹ ²:

- Molar Substitution (MS): The label should indicate the MS value, which represents the number of hydroxypropyl groups per anhydroglucose unit. The MS value should be between 0.40 and 1.50, and within 10% of the stated value.

- Intended Use: If HP-β-CD is intended for use in the manufacture of injectable dosage forms, it should be clearly labeled as such. Additionally, if further processing is required to ensure acceptable levels of bacterial endotoxins, this should also be stated.

- Sterility: If HP-β-CD is sterile, the label should indicate this. Sterility tests should meet the requirements of the relevant dosage form monograph.

- Bacterial Endotoxins: The label should specify the level of bacterial endotoxins, which should be less than 10 IU/g if intended for use in parenteral preparations without further processing.

- Microbial Contamination: The total aerobic microbial count should not exceed 1000 CFU/g, and the total combined molds and yeasts count should not exceed 100 CFU/g.

- Content: The label should state the content of hydroxypropyl groups per anhydroglucose unit, expressed as molar substitution.

- Storage Conditions: The label should specify storage conditions, such as room temperature and well-closed containers.

- Labeling for Parenteral Preparations: If HP-β-CD is used in parenteral preparations, the label should meet specific requirements, including TAMC ≤ 100 CFU/g, TYMC ≤ 10 CFU/g, absence of Escherichia coli, and absence of Salmonella.

These labeling requirements ensure the safe and effective use of HP-β-CD in various applications, including pharmaceuticals and biotechnology.

 

 

Where can Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC are procured?

Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

FOR API

MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

GST No: 27DHUPM2366D1ZZ

For Dosage Forms :

- Online Marketplaces: You can find Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Hydroxypropyl-Beta-Cydodextrin Manufactured by MEDIOCON INC product, regardless of the procurement source.