Cycloserine 68-41-7 Manufacturer Exporter Supplier MEDIOCON INC
Cycloserine Manufactured
by MEDIOCON INC
Name: Cycloserine
CAS No: 68-41-7
Molecular Weight: 102.09 g/mol
Molecular formula: C3H6O2N2
Synonyms: D-cycloserine,
Seromycin, Oxamycin, and D-4-Amino-3-isoxazolidinone
Appearance: white to off-white crystalline hygroscopic powder.
Solubility : soluble in water and slightly soluble
in methanol and propylene glycol
Use :
Cycloserine
is an antibiotic used to treat various bacterial infections. Here are its main
uses:
-
Tuberculosis (TB): Cycloserine is used as part of a combination treatment for
active pulmonary and extrapulmonary TB, especially for drug-resistant strains.
- Urinary
Tract Infections (UTIs): It treats certain types of UTIs caused by susceptible
bacteria, such as Enterobacter species and Escherichia coli.
-
Bacterial Skin Infections: Cycloserine is effective against bacterial skin
infections.
-
Conjunctivitis: It treats conjunctivitis caused by susceptible bacteria.
Cycloserine
works by inhibiting bacterial cell wall synthesis, making it effective against
a range of bacterial infections.
How
is Cycloserine manufactured by MEDIOCON INC Synthesized?
Cycloserine is synthesized through various
methods, including biosynthesis and chemical synthesis.
Biosynthesis- Cycloserine is produced
biosynthetically from actinomycetes like Streptomyces garyphalus, Streptomyces
orchidaceus, and Streptomyces lavendulae.
- The process involves a ten-gene cluster,
converting L-serine and L-arginine into O-ureido-L-serine, then
O-ureido-D-serine, and finally cycloserine through cyclization.
Chemical Synthesis- Cycloserine can be
synthesized chemically from D-serine methyl ester.
- The process involves replacing the hydroxyl
group with a chlorine atom using phosphorous pentachloride, followed by
reaction with hydroxylamine to form cycloserine.
- Other methods include using
protection-deprotection strategies, starting with D-serine, and employing
cyclization reactions as key steps.
Recent Developments- Researchers have developed
efficient and facile synthesis methods, achieving high yields (up to 61%) and
purity (>99%).
- These methods involve simple treatment and
mild reaction conditions, making them attractive for large-scale production.
What are
the different dosage forms of Cycloserine
Manufactured by MEDIOCON INC?
Cycloserine is available in the following dosage forms:
- Capsules: 250 mg
- Oral Capsules: 250 mg
The dosage of Cycloserine varies depending on the condition being
treated, patient's age, weight, and renal function. Here are some general
guidelines¹ ² ³:
- Adults: 250-500 mg orally every 12 hours, up to a maximum of 1 g/day
- Children: 10-20 mg/kg/day orally in divided doses, up to a maximum of 1
g/day
- Renal Impairment: Dosage adjustment is necessary; consult a healthcare
professional for guidance
It's essential to follow the prescribed dosage and administration
instructions to ensure effective treatment and minimize side effects.
How
Cycloserine Manufactured by MEDIOCON INC Dosage Forms are prepared?
Cycloserine dosage forms, specifically capsules,
are prepared through a series of steps:
- Blending: The active pharmaceutical ingredient
(API), cycloserine, is blended with excipients like fillers, disintegrants, and
lubricants.
- Encapsulation: The blended mixture is then
filled into empty capsule shells using an encapsulation machine.
- Quality Control: The filled capsules undergo
quality control checks, including weight variation, disintegration, and
dissolution tests.
- Packaging: The capsules are packaged in
containers or blister packs, labeled, and prepared for distribution.
The preparation process may vary depending on
the manufacturer and specific formulation. Some common excipients used in
cycloserine capsules include [1][2]:
- Fillers: Microcrystalline cellulose, lactose
monohydrate
- Disintegrants: Croscarmellose sodium,
crospovidone
- Lubricants: Magnesium stearate, stearic acid
It's crucial to follow Good Manufacturing
Practices (GMP) and ensure the quality of the final product.
What are
the appropriate Dosage forms of Cycloserine Manufactured by MEDIOCON INC?
Cycloserine
is available in the following dosage forms:
-
Capsules: 250 mg
- Oral
Capsules: 250 mg
The
dosage of Cycloserine varies depending on the condition being treated,
patient's age, weight, and renal function. Here are some general guidelines:
- Adults:
250-500 mg orally every 12 hours, up to a maximum of 1 g/day
-
Children: 10-20 mg/kg/day orally in divided doses, up to a maximum of 1 g/day
- Renal
Impairment: Dosage adjustment is necessary; consult a healthcare professional
for guidance
When should
Cycloserine Manufactured by MEDIOCON INC be taken?
Cycloserine should be taken according to the following guidelines:
- Oral Administration: Take cycloserine orally, usually every 12 hours.
- With or Without Food: Cycloserine can be taken with or without food.
- Consistency: Take cycloserine at the same time(s) every day to
maintain consistent blood levels.
- Duration: Continue taking cycloserine for the full prescribed
duration, even if symptoms improve.
Specific Timing- Adults: 250-500 mg every 12 hours.
- Children: 10-20 mg/kg/day in divided doses every 12 hours.
Important Considerations- Renal Impairment: Dosage adjustment is
necessary; consult a healthcare professional.
- Monitoring: Regular monitoring of blood levels, renal function, and
neurological status is recommended.
What
are the effects And Side effects of Cycloserine Manufactured by MEDIOCON
INC?
Cycloserine
is an antibiotic used to treat tuberculosis (TB) and urinary tract infections
(UTIs). Here are its effects and potential side effects:
Effects:-
Antibacterial: Cycloserine is effective against Mycobacterium tuberculosis and
certain bacteria causing UTIs, such as Enterobacter species and Escherichia
coli.
-
Bactericidal/Bacteriostatic: Depending on concentration, cycloserine kills
bacteria or inhibits their growth.
Side
Effects:- Common:
- Anxiety, confusion, dizziness, drowsiness
- Headache, irritability, mood changes
- Numbness, tingling, or burning sensations
- Speech difficulties, tremors
- Less
Common:
- Convulsions (seizures), coma
- Depression, psychosis, suicidal thoughts
- Elevated liver enzymes, heart failure
- Vitamin B12 deficiency, anemia
Precautions:-
Contraindicated: Severe kidney impairment, epilepsy, severe anxiety, psychosis,
chronic alcoholism
- Use
with Caution: History of seizures, mental disorders, kidney or liver disease
- Avoid
Alcohol: Increases risk of seizures and adverse reactions
Consult a
healthcare professional for personalized guidance on using Cycloserine
How
is Cycloserine Manufactured by MEDIOCON INC Tested
Qualitatively?
Cycloserine
is tested qualitatively using a simple test based on its deterioration. When
cycloserine deteriorates, it forms a yellow solution when dissolved in dilute
alkali. This test is particularly useful in humid tropical climates where
cycloserine may degrade quickly.
To
perform this test, a sample of cycloserine is dissolved in dilute alkali. If
the solution turns yellow, it indicates that the cycloserine has deteriorated.¹
² ³
Additionally,
other methods like UPLC (Ultra-Performance Liquid Chromatography) and LC-MS
(Liquid Chromatography-Mass Spectrometry) can be used to analyze cycloserine
solutions and detect degradation.
Which
tests are performed on Cycloserine Manufactured by MEDIOCON INC ?
Several
tests are performed on Cycloserine to ensure its quality and purity. Some of
these tests include:
-
Identification Test: A simple test based on the deterioration of Cycloserine,
where a yellow solution is formed when dissolved in dilute alkali.
- Purity
Tests: To detect impurities and degradation products.
- Assay:
To determine the potency and concentration of Cycloserine.
- UPLC
(Ultra-Performance Liquid Chromatography): To analyze Cycloserine solutions and
detect degradation.
- LC-MS
(Liquid Chromatography-Mass Spectrometry): To analyze Cycloserine solutions and
detect degradation.
-
Dissolution Test: To ensure the Cycloserine capsules dissolve properly.
-
Disintegration Test: To ensure the Cycloserine capsules disintegrate properly.
- Weight
Variation Test: To ensure the Cycloserine capsules have uniform weight.
What are
the challenges in Manufacturing of Banana Extract Manufactured by
MEDIOCON INC API?
Manufacturing
Banana Extract API comes with several challenges:
-
Extraction Efficiency: Optimizing extraction methods to maximize yield and
minimize degradation of bioactive compounds.
-
Standardization: Ensuring consistent quality and potency of the extract.
-
Contamination Risk: Preventing contamination during processing and storage.
-
Scalability: Scaling up production while maintaining quality and efficiency.
-
Regulatory Compliance: Meeting regulatory requirements for API manufacturing.
Additionally,
banana-based products face challenges like¹ ² ³:
-
Seasonal Variability: Managing fluctuations in raw material availability and
quality.
- Waste
Management: Utilizing banana waste effectively to reduce environmental impact.
- Cost Competitiveness:
Balancing production costs with market demand and competition.
Addressing
these challenges requires innovative solutions, efficient processes, and
adherence to quality standards.
What are
the challenges in manufacturing of Cycloserine Manufactured by
MEDIOCON INC ’s Dosage forms?
Manufacturing
Cycloserine dosage forms comes with several challenges:
-
Stability Issues: Cycloserine degrades over time, affecting potency and safety.
- Poor
Solubility: Cycloserine has limited solubility, impacting bioavailability.
-
Microbial Contamination: Risk of contamination, particularly in liquid forms.
- Product
Uniformity: Ensuring consistent potency and quality.
-
Regulatory Compliance: Meeting stringent regulatory standards.
-
Specialized Equipment: Requires specific equipment for handling and processing.
-
Packaging and Storage: Needs proper packaging and storage to maintain
stability.
What is the
Packing for Cycloserine Manufactured by MEDIOCON INC?
Cycloserine
is packed in various sizes, including¹ ² ³:
- 10X6
Capsules: A common packaging size for Cycloserine 250mg capsules
- 10X10
Capsules: Another popular packaging size for Cycloserine 250mg capsules
- 1X10
Capsules: A smaller packaging size for Cycloserine 250mg capsules
- 30
Capsules: Available in blister packs or bottles
- Box of
3X10 Capsules: A larger packaging size for Cycloserine 250mg capsules
Some
manufacturers also offer customized packaging options. The packaging is
designed to maintain the stability and efficacy of the medication.
What is shelf
life Of Cycloserine Manufactured by MEDIOCON INC?
Cycloserine's
shelf life varies depending on storage conditions and packaging. Here are some
general guidelines¹ ² ³:
- Powder
Form: 60 months when stored at 2-8°C (refrigerated)
-
Specific Products:
- TSC Agar: 12 months at 2-30°C
- Cycloserine-Cefoxitin Fructose Agar: 90
days from manufacture date
- TSC Agar Supplement: Limited shelf life,
expiry date on label
To extend
shelf life, store Cycloserine in⁴:
- Cool,
dry places
-
Airtight containers
- Away
from direct sunlight and moisture
What should
the label claim for Cycloserine Manufactured by MEDIOCON
INC Include?
The label
claim for Cycloserine should include the following information:
- Product
Name and Description: Clearly indicate the product name, such as
"Cycloserine Capsules, 250mg"
- Active
Ingredient: Specify the active ingredient, Cycloserine
-
Strength: Indicate the strength, 250mg
- Dosage
Form: Specify the dosage form, capsules
-
Ingredients: List all ingredients, including inactive ingredients like
magnesium oxide, talc, and gelatin
-
Warnings and Precautions: Include warnings about CNS toxicity and other
potential risks
-
Directions for Use: Provide clear instructions on how to take the medication
-
Manufacturer Information: Include the manufacturer's name, address, and contact
information
- NDC
Number: Specify the National Drug Code (NDC) number, such as 33342-462-06
-
Packaging Information: Describe the packaging, such as "30 Capsules,
Non-Child Resistant"
- Bar
Code: Include a bar code for accurate scanning
-
Statement of Identity: Include a statement of identity, such as
"Cycloserine Capsules USP, 250 mg"
Where can Cycloserine
Manufactured by MEDIOCON INC are procured?
Cycloserine
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 Cycloserine 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 Cycloserine
Manufactured by
MEDIOCON INC products.
Remember to ensure the quality and
authenticity of the Cycloserine Manufactured by
MEDIOCON INC product, regardless of the procurement source.
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