Get Quote Now

CALL US NOW

+44 7361560931

Whatsapp: +44 7361560931

info@kingyork.co.uk

info@kingyork.co.uk

+44 7361560931

Pharmaceutical Syrups

Pharmaceutical syrups are liquid preparations that contain one or more active pharmaceutical ingredients dissolved in a flavored or unflavored syrup base. They are designed to facilitate the oral administration of medications, especially for patients who have difficulty swallowing pills or capsules.

The key components of a pharmaceutical syrup include:

- Active pharmaceutical ingredient(s)

- These provide the therapeutic effect of the medication. Common examples include antibiotics, analgesics, antihistamines, antitussives, and vitamins.

- Excipients

- Substances like glycerin, sorbitol, flavors, preservatives, colorants, etc. that enhance the stability, appearance, taste and administration of the final formulation.

- Sweetening agents

- Sugar syrups like sucrose, sorbitol or glycerin provide sweetness and palatability. They increase viscosity and prevent sedimentation of insoluble ingredients.

- Purified water

- Serves as the liquid base into which other components are dissolved.

- Buffers

- Help maintain an optimal pH for stability and taste.

- Preservatives

- Prevent microbial growth in the aqueous base. Common examples are sodium benzoate, potassium sorbate, and parabens.

Pharmaceutical syrups are most commonly administered orally. Due to their palatability and ease of swallowing, they are especially useful for pediatric, geriatric patients and those who cannot swallow tablets or capsules. Syrups help mask any unpleasant tastes of active ingredients and ensure proper dosing for children. They are also suitable for systemic delivery of actives that undergo degradation in the gastric environment. Common therapeutic applications include antibiotics, analgesics, antihistamines, multivitamins, antitussives, antacids, etc. Overall, syrups provide an effective platform to deliver medications through the oral route.

'paracetamol syrup', 'analgesic syrup', 'paracetamol 125mg syrup', 'paracetamol'

paracetamol syrup

'azithromycin syrup', 'antipyretic syrup', 'azithromycin 125mg syrup', 'azithromycin'

Azithromycin syrup

Active Pharmaceutical Ingredients

Active pharmaceutical ingredients (APIs) are the components of a drug that produce its intended therapeutic effect. When formulating syrups, careful consideration must be given to the selection of APIs.

'azithromycin syrup', 'antipyretic syrup', 'azithromycin 125mg syrup', 'azithromycin'

Azithromycin syrup

'paracetamol syrup', 'analgesic syrup', 'paracetamol 125mg syrup', 'paracetamol'

paracetamol syrup

Common APIs Used in Syrups

Some of the most commonly used APIs in syrup formulations include:

- Analgesics like acetaminophen and ibuprofen to relieve pain

- Antitussives like dextromethorphan to suppress coughs

- Expectorants like guaifenesin to loosen mucus

- Antihistamines like diphenhydramine for allergy relief

- Decongestants like pseudoephedrine to relieve nasal congestion

- Antibiotics like amoxicillin to treat infections

The choice of API depends on the intended therapeutic use of the syrup. Most syrups contain just one API, but some may combine multiple active ingredients.

'paracetamol syrup', 'analgesic syrup', 'paracetamol 125mg syrup', 'paracetamol'

paracetamol syrup

'azithromycin syrup', 'antipyretic syrup', 'azithromycin 125mg syrup', 'azithromycin'

Azithromycin syrup

Solubility Considerations

A key factor in selecting APIs for syrups is solubility. Syrups are aqueous solutions, so the API must have sufficient solubility in water for the intended dose. APIs with low aqueous solubility may need solubilizing agents added to the formulation.

For ionizable APIs, solubility depends greatly on pH. The syrup's pH may need adjustment to keep the API dissolved. Syrups generally have a pH between 4-6 for optimal API stability and palatability.

'azithromycin syrup', 'antipyretic syrup', 'azithromycin 125mg syrup', 'azithromycin'

Azithromycin syrup

'paracetamol syrup', 'analgesic syrup', 'paracetamol 125mg syrup', 'paracetamol'

paracetamol syrup

Stability

Active ingredients in syrups can degrade via hydrolysis, oxidation, temperature, and other factors. The manufacturer must test API stability under typical storage conditions and shelf life.

Certain excipients like antioxidants and chelating agents may improve API stability. The container closure system also impacts stability. Refrigerated storage may be needed for some syrups.

API stability data guides the labeled expiration date and storage conditions for the final syrup product. Careful API selection and formulation are crucial for an optimal shelf life.

Excipients

Excipients play a critical role in pharmaceutical syrup formulations. They help impart important physical properties to the syrup, mask any unpleasant taste of the active pharmaceutical ingredient (API), and improve stability.

Some common excipients used in syrups include:

- **Viscosity modifiers**

- These excipients help modulate the viscosity and flow behavior of the syrup. Examples include glycerin, sorbitol, sucrose, and carboxymethylcellulose sodium. They help provide an ideal thickness and mouthfeel.

- **Sweeteners**

- Sweeteners like sucrose, fructose, or artificial sweeteners are added to mask any bitter taste of the API and improve palatability. The choice and combination of sweeteners can impact properties like viscosity, stability, and sweetness perception.

- **Preservatives**

- Preservatives prevent microbiological contamination and spoilage of the syrup. Common preservatives include methylparaben, propylparaben, potassium sorbate, and sodium benzoate. The level of preservative is carefully optimized to provide efficacy while ensuring patient safety.

- **Flavors & colors**

- Flavoring agents like lemon oil or orange flavor and permitted coloring agents are often added to improve the esthetics and taste masking of syrups.

The choice and levels of excipients can significantly impact the pharmaceutically relevant properties of the final syrup product like viscosity, palatability, microbial quality, and API stability. Excipient compatibility and optimization is a critical step in developing stable and patient-centric syrup formulations.

Syrup Manufacturing Process

The manufacturing process for pharmaceutical syrups involves several key steps to produce a homogeneous, stable, and safe final product.

Mixing and Dissolving APIs

The active pharmaceutical ingredients (APIs) are first accurately weighed and added to the syrup base in the desired concentration. The APIs are dissolved through mechanical mixing and agitation. High shear mixers are often used to ensure proper dispersion and dissolution of the APIs. Factors like temperature, pH, and mixing time must be controlled to achieve optimal dissolution.

Filtration

Once dissolved, the syrup solution goes through filtration to remove any undissolved particles or impurities. Different filtration methods like vacuum, pressure, or membrane filtration can be utilized based on the viscosity and composition of the syrup. Proper filtration helps improve the clarity, stability and shelf life of the final product.

Homogenization

The filtered syrup solution then undergoes homogenization to reduce the particle size and evenly distribute the ingredients. Homogenization is done using equipment like high-pressure homogenizers. It improves the consistency, texture, and mouthfeel of the final syrup.

Filling/Packaging

The final step is aseptic filling and packaging of the homogeneous syrup solution into bottles, sachets or other packaging. Accuracy of fill volumes and integrity of packaging material is crucial. The filled syrups go through final checks before release. Automated filling and packaging lines are commonly used for efficiency and quality control.

Proper control and validation of the manufacturing process is key to producing a high-quality pharmaceutical syrup at commercial scale.

Quality Control Testing

Quality control testing is a critical part of pharmaceutical syrup manufacturing to ensure the final product meets specifications and is safe for human consumption. Some of the key tests conducted are:

Viscosity Testing

- Measures the thickness and flow characteristics of the syrup

- Important to ensure proper pouring and dosing of the medication

- Typically measured using a viscometer, which determines the syrup's resistance to flow

- Results compared to established viscosity specifications

Microbial Testing

- Screens for contamination by bacteria, mold, yeast

- Usually involves taking samples and culturing them on growth media

- Checks for pathogens like E. coli, Salmonella, Staphylococcus

- Ensures product sterility and lack of bioburden

Chemical Assay

- Verifies the proper amount of active pharmaceutical ingredient (API) is present

- Uses analytical techniques like high-performance liquid chromatography

- Measures concentration of API against a reference standard curve

- Confirms API content meets requirements

pH Testing

- Measures acidity/alkalinity of the syrup

- Can affect solubility, stability, and taste of the product

- Performed using a pH meter on samples

- Results must fall within established pH specification range

Proper quality control testing ensures the final syrup product is safe and effective for patient use. Failures can lead to recalls, health hazards, or lack of efficacy if out of specification.

Regulations

The manufacturing of pharmaceutical syrups is a highly regulated process. Companies must follow Good Manufacturing Practices (GMP) guidelines and comply with rules from regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Good Manufacturing Practices

GMP guidelines provide a framework of minimum requirements for the methods, facilities, and controls used in manufacturing, processing, packing, and holding drugs. They aim to ensure that syrups are produced consistently and controlled according to quality standards. GMP regulations address qualifications and training, buildings and facilities, equipment, control of components and packaging materials, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports, and returned and salvaged products.

Regional Regulations

In the United States, pharmaceutical syrups must meet FDA requirements. The FDA inspects manufacturing facilities and reviews data to ensure safety, effectiveness, quality, and accurate labeling. Companies must register facilities engaged in pharmaceutical production and list all drugs made at each facility. The FDA also expects compliance with current Good Manufacturing Practices.

In Europe, the EMA works with EU members to oversee medicines regulation. Manufacturers must comply with EU good manufacturing practice principles and guidelines. The EMA can inspect sites and issue good manufacturing practice certificates. Each country also has its own national competent authority responsible for regulating pharmaceutical products.

Regulations also exist in other countries and regions like Canada, Australia, Japan, and emerging markets. Companies looking to sell globally must understand and adapt to a complex world of regulatory requirements. With increased outsourcing and globalization, cooperation between international regulators continues to grow.

Facility and Equipment

Manufacturing pharmaceutical syrups requires specialized equipment and facilities to ensure product quality and safety. Some key considerations include:

**Manufacturing Equipment**

- Stainless steel tanks and pipes should be used to mix and transfer ingredients and bulk syrup. Stainless steel prevents corrosion and minimizes contamination.

- Mixers, blenders, homogenizers, and mills are needed to properly combine ingredients and achieve uniform particle sizes in suspensions.

- Filtration systems remove impurities and clarify the syrup. Multiple filtration steps are often used.

- Filling machines accurately dispense the syrup into bottles, jars or other final packaging. Automated filling lines improve efficiency.

- Labeling and sealing equipment prepares the final packaged product. Track and trace systems may be implemented.

**Cleanroom Standards**

- Syrup manufacturing facilities should meet cGMP and ISO classifications for cleanrooms. Higher ISO classes (7 or 8) are ideal for sterile syrups.

- Air filtration, room pressurization, gowning procedures and cleaning protocols must be in place to control airborne particulates and microbial contamination.

- Regular environmental monitoring should be performed to ensure cleanroom conditions are maintained.

- Dedicated gowning rooms separate the manufacturing space from lower hygiene areas. Personnel follow hand washing and gowning procedures.

Proper equipment selection, facility design, and contamination controls give pharmaceutical syrups the high quality expected of human drugs. Regulators closely inspect facilities and manufacturing processes.

Trends and Innovations

The pharmaceutical syrup manufacturing industry continues to evolve with new technologies and innovations. Some key trends shaping the future of syrup production include:

**Flavored and specialized syrups**

- There is growing demand for flavored syrups, especially for pediatric populations, that taste better and mask unpleasant drug flavors. Companies are developing fruit and sweetener flavor systems to improve palatability. Specialized syrups are also emerging, like viscosity-adjusted syrups that aid swallowing difficulties.

**Modified release syrups**

- Modified release syrup formulations are being introduced to control the drug release rate. These include sustained release, delayed release, and extended release syrups. Manufacturers use technologies like ion exchange resins, micro-encapsulation, and lipid-based systems to modify drug delivery.

**Automation**

- Automated systems are being implemented to improve efficiency, accuracy, and compliance. Syrup production lines now integrate automated dispensing, inspection, and packaging. Robotic arms can handle repetitive tasks like material transfer. Inline quality control checks using sensors reduce human errors. Automation also aids compliance with electronic batch records.

These innovations allow pharmaceutical companies to create novel syrup products, scale up production, reduce costs, and meet quality standards more easily. However, implementing new technologies requires significant investment and expertise. Overall, the industry is moving towards more customized, controlled, efficient, and compliant manufacturing processes.

Common Issues and Solutions

Pharmaceutical syrup manufacturing comes with some common challenges that manufacturers need to be aware of and implement strategies to prevent.

Microbial Contamination

Microbial contamination is a significant risk in syrup production that can lead to product recalls or consumer illness. Suggested ways to prevent microbial contamination include:

- Careful cleaning and sanitization of manufacturing equipment

- Ensuring raw materials have been sufficiently tested

- Working in cleanroom environments

- Following strict hygiene protocols for staff

- Incorporating microbial retention filters on lines

- Conducting regular microbial testing at various stages

Crystal Formation

Crystal formation can occur when syrup ingredients fall out of solution. This affects visual quality and can cause dosing issues. Ways to prevent crystals include:

- Careful selection of excipients for solubility

- Adding stabilizing or solubilizing agents

- Maintaining proper storage and distribution temperatures

- Agitation during storage to prevent settling

- Built-in microfiltration steps

Separation

Syrup separation happens when the syrup's components split, causing visual and dosing problems. To prevent separation:

- Select optimal ingredient ratios and compatible excipients

- Incorporate suspending, stabilizing, and emulsifying agents

- Use homogenization during processing

- Ensure proper viscosity

- Carry out stability studies to confirm shelf life

With careful manufacturing processes and testing, these common issues in syrup production can be prevented.

Conclusion

Pharmaceutical syrups play an important role in making oral drug administration more palatable and effective, especially for children and the elderly. The manufacturing process requires careful attention to ensure product quality and safety.

Key steps include creating a uniform syrup base, dissolving or suspending the active pharmaceutical ingredients, testing and quality control, and sterile bottling. At each stage, factors like ingredient compatibility, temperature, pH, viscosity, and microorganisms must be monitored and controlled. Proper equipment cleaning and sanitization between batches is also critical.

Stringent regulations guide syrup manufacturing to protect consumers. Facilities must adhere to cGMP and local guidelines. Detailed protocols, training, and documentation ensure standards are met consistently. Any deviations can impact syrup potency or stability.

By leveraging technology and expertise, manufacturers can optimize efficiency and output. However, quality must remain the top priority. Syrups that are contaminated, ineffective, or unstable can pose major health risks. Ensuring safety and efficacy from raw materials selection to final release testing is paramount

With careful attention to detail and quality, pharmaceutical syrups can safely provide patients, especially children, with the intended therapeutic effects. Responsible manufacturing principles help ensure these important oral liquid medicines are produced to the highest standards.

Registration:

We will prepare registration documents and certificates as necessary.

Product List - Liquid Injections


Product NameStrength
Vitamin B1 injection 100mg: 2ml
Vitamin B6 Injection 0.1g: 2ml
Vitamin B12 injection 0.5mg:1ml
VIT-B Complex injection 2ml
Tri B-inj B1-100mg+B2-100mg+B12-1000mcg 3ml
Vitamin C injection 0.5g:2ml
VITAMIN K1 injection 10mg:1ml
Dexamethasone Na phosphate injection 4mg: 1ml
Dexamethasone Na phosphate injection 8mg: 2ml
Diclofenac Sodium Injection 75mg:3ml
Metoclopramide hydrochloride injection 10mg:2ml
Metoclopramide hydrochloride injection 5mg:1ml
Iron Sucrose IV Injection 100mg:5ml
Iron Dextran Injection 100mg:2ml
Promethazine Hydrochloride Injection 50mg:2ml
Gentamycin sulfate injection 40mg:2ml
Gentamycin sulfate injection 80mg:2ml
Furosemide Injection 20mg:2ml
Aminophylline Injection 250mg:10ml
Paracetamol injection 150mg:1ml
Paracetamol injection 300mg:2ml
Paracetamol injection 500mg:4ml
Paracetamol injection 600mg:4ml
Paracetamol injection 750mg:5ml
Diazepam injection 5mg/1ml
Diazepam injection 10mg:2ml
Diazepam injection 5mg/1ml
Diazepam injection 10mg:2ml
Oxytocin Injection 5 iu/1ml
Oxytocin Injection 10 iu / 1ml
Chlorphenamine Maleate Injection 10mg:1ml
Hyoscine Butylbromide(Buscopan)Injection 20mg:1ml
Lidocaine Hydrochloride injection 10ml:0.2g
Methotrexate for Injection 50mg:2ml
ENOXAPARIN SODIUM Prefilled syringe 40MG/0.4ML
ENOXAPARIN SODIUM Prefilled syringe 60MG/0.6ML
ENOXAPARIN SODIUM Prefilled syringe 80MG/0.8ML
Adrenaline(Epinephrine HCL)Injection 1mg:1ml
Testosterone 250mg:1ml 250mg:1ml

Product List - Vial Injections

Product Name Strength
Omeprazol 40 mg IV VIAL 10ml or 5ml
Pantoprazole Sodium for Injection 40mg
Lansoprazole for Injection 30 mg
Ceftriaxone 1gm/10ml IV VIAL +10ml water
Ceftriaxone 1gm/10ml VIAL +Lidocain 1%
Ceftriaxone IM/IV VIAL 500mg/15 ml
Ampicillin Na VIAL 0.5 g/Vial
Ampicillin Na VIAL 1g/Vial
Cefotaxime Sodium for VIAL 1g/Vial
Ceftazidime For I.M/I.V VIAL 1g/Vial
Cefepime For I.M/I.V VIAL 1g/Vial
Meropenem VIAL Injection 1g/20ml/Vial
Procaine Penicillin(0.4mega/7ml) 400.000 U/7ml
Procaine Penicillin(0.6mega/7ml) 600.000 U/7ml
Procaine Penicillin(1.2mega/7ml) 800.000 U/7ml
Procaine Penicillin (0.8mega/7ml) 1200.000 U/7ml
Benzathine Penicillin for Injection 1.2mega/7ml
Vancomycin Hcl injection 500mg 500mg/Vial
Vancomycin Hcl injection 500mg 1g/Vial
Heparin Sodium Injection 5ml:5000 units
Heparin Sodium Injection 5ml:25000 units
Amoxicillin Na and Clavulanate Potassium for Inj(augmentin) G Powder 1.2
Amoxicillin Na and Clavulanate Potassium for Inj(augmentin) G Powder 0.6
lyophilized Hydrocortisone Na Succinate 3ml:0.1gm
aseptic lyophilized Hydrocortisone Na Succinate 7m:0.1gm
Phenobarbital Sodium Injection 1ml:0.1g
Piperacillin Sodium and Tazobactam Na for Inj 4.5g

Product List - IV INFUSION

Product Name Strength
Paracetamol 1G IV infusion 100ml glass bottle
Metronidazole 500mg IV infusion 100ml glass bottle
Ciprofloxacine 200mg IV infusion 20ml plastic bottle
0.9% Na Chloride IV Inj 500ml plastic bottle
5% Glucose Injection 250ml:12.5g,500ml:25g
10% Glucose Injection 250ml:12.5g,500ml:25g
Sodium Lactate Ringer`s Inj 500ml Plastic Bottle
5% Glu + 0.9% Na Chlorid inj 250ml: Glu 12.5g,NaCl 2.25g
5% Glu + 0.9% Na Chlorid inj 500ml: Glu 25g,NaCl 4.5g
10% Glu + 0.9% Na Chlorid inj 250ml: Glu 25g,NaCl 2.25g
10% Glu + 0.9% Na Chlorid inj 500ml: Glu 50g,NaCl 4.5g
Mannitol injection 250ml:50g P Bottle

Product List - SYRUP

Product Name Strength
Amoxicillin 125mg + Clavulanic Acid 31.5mg 100 ml glass Bottle
Amoxicillin 250mg + Clavulanic Acid 62.5mg 100 ml glass Bottle
Amoxicillin 400mg + Clavulanic Acid 75mg 100 ml glass Bottle
Azithromycine 100mg 15ml 1bottle/Box
Metronidazole 125mg 100 ml glass Bottle
Metronidazole 250mg 100 ml glass Bottle
Amoxicillin 125 mg 100 ml glass Bottle
Amoxicillin 250 mg 100 ml glass Bottle
Paracetamol syrup 250mg/5ml 250mg/5ml syrup
Ibuprofen Dry Suspension 100mg/5ml 100ml Suspension

Product List - TABLETS

Product Name Strength
Azithromycine 500mg Tab(3 tabs) 3 tablets X 1 blister
Metronidazole 500mg Tab(14 tabs) 7 tablets X 2 blisters
Ciprofloxacine 500mg TAB(10 tabs) 10 tablets X 1 blister
Amoxicillin 250mg + Clavulanic Acid 125mg(14 tabs) 7 tablets x 2 blister
Amoxicillin 500mg + Clavulanic Acid 125mg(14 tabs) 7 tablets x 2 blister
Amoxicillin 875mg + Clavulanic Acid 125mg(14 tabs) 7 tablets x 2 blister
Nitrofurantoin 100mg Tablets 10 tablets X 1 blister
Aspirin Enteric-coated 500mg 10 tablets X 1 blister
Paracetamol 500mg 10 tablets X 1 blister
Ibuprofen 400mg 10 tablets X 1 blister
Diclofenac Na 400mg 10 tablets X 1 blister
Diclofenac 50mg + Paracetamol 500mg 10 tablets X 1 blister
Folic acid 5mg Tab 10 tablets X 1 blister
Ciprofloxacin Tablets 10 tablets X 1 blister
Doxycycline 100mg Tab 10 tablets X 1 blister
Meloxicam 15mg Tab 10 tablets X 2 blisters
Fluconazole 150mg Tab 10 tablets X 2 blisters
Simvastatin 40mg Tab 10 tablets X 2 blisters
Prednisolone 5mg Tab 10 tablets X 2 blisters
Spiramycin 750,000 unit Tab 10 tablets X 2 blisters
Spiramycin 1,500,000 unit Tab 10 tablets X 2 blisters

Product List - CAPSULES

Product Name Strength
Amoxicillin 500mg(16 Capsules) 8 cap X 2 blisters
Ampicillin Capsules 10 cap X 2 blisters
Cloxacillin Na Capsules 10 cap X 2 blisters
Piroxicam Capsule 10 cap X 2 blisters
Tetracyline 250 mg Capsule 10 cap X 2 blisters
Oxytetracycline 250mg Capsule 10 cap X 2 blisters
Spiramycin 375,000 unit Cap 10 cap X 2 blisters
Indomethacin 25mg Capsule 10 cap X 2 blisters

Product List - Suppository

Product Name Strength
Paracetamol 125mg suppository 5 Supp x 2 blister
Paracetamol 250mg suppository 5 Supp x 2 blister
Policresulen Vaginal 90mg Suppository 4 Supp x 2 blister
Chlorhexidine Acetate 20mg Supp 5 Supp x 2 blister
Miconazole Nitrate Vaginal 100mg Supp 5 Supp x 2 blister
Clotrimazole Vaginal 150mg Supp 5 Supp x 2 blister
Metronidazole Vaginal 500mg Supp 5 Supp x 2 blister
Indomethacin 500mg Supp 5 Supp x 2 blister