In the Dry Syrup Manufacturing Process, there is careful mixing, granulation, dehydration and filling of moisture-resistant containers with powdered substances and excipients. As a result, pediatric and antibiotic preparations get increased shelf life after being dissolved in water. In addition, the companies prefer dry suspensions, as liquid medications have a very short shelf life.
Thus, setting up an automated production line implies capital expenditures ranging from 15 lakh to 50 lakh rupees. In addition, the parent companies should strictly follow the rules of WHO-GMP standards to prevent contamination between different batches.
Contact Us: +(91) – 9412054069
How Are Ingredients Prepared for the Dry Syrup Manufacturing Process?
For a Dry Syrup Formulation Process, there is a need to accurately measure and sift raw materials in a humidified environment. The first step is to weigh active pharmaceutical ingredients (APIs) and dry excipients using calibrated digital balances. Further, all raw powders are sieved with 40-mesh to 60-mesh stainless steel screens. Due to proper sieving, the dispersion of sweeteners, flavors, and preservatives becomes easier in the process of customer reconstitution. Maintaining relative room humidity below 40% becomes critical for raw materials preparation.
- APIs and excipients are weighed accurately according to approved master batch records.
- All raw ingredients are sifted through 40-mesh to 60-mesh stainless steel screens.
- Dehumidifiers are kept running in order to keep the relative humidity of the environment below 40%.
- High-shear mixers are used for mixing dry powders for the purpose of achieving the necessary uniformity of content.
The average cost of standard raw material preparation is from 2 lakh to 8 lakh rupees per large batch.
What Are the Main Stages of Dry Syrup Manufacturing?
The dry syrup manufacturing steps outline how raw materials transform into shelf-stable pediatric suspensions through precise environmental control and technical stages.
Dry Blending Stage
The dry syrup manufacturing process starts with loading the sifted powders into double-cone or octagonal blenders. As a consequence, the machinery mixes APIs, binders, and flavors for 20 to 30 minutes to avoid active ingredient segregation.
Wet Granulation Process
Dry syrup manufacturing process is often conducted by means of binder solutions that convert light powders into dense granules. In addition, non-aqueous solvents or liquid binders are sprayed onto the powder bed to improve the flowability of the substance during the automated bottle filling process.
Controlled Moisture Drying
Granules enter the fluid bed dryers in order to dry out. As a result, inlet temperature is maintained at the level of 50°C to 60°C, which ensures that the final moisture content is below 1.5%. This will maintain drug potency during the Dry Syrup Production Process.
Granule Sizing and Sieving
Dried granules enter multi-mills that are equipped with fine screens in order to standardize granule sizes. In such a way, proper uniformity of granule sizes prevents the formation of powder bridges inside hoppers of machines and ensures exact dosing.
Automated Bottle Filling
Specialized high-speed dry powder filling machines can fill amber glass or HDPE bottles at a speed of 120 bottles per minute. As a result, an induction seal prevents the penetration of ambient air in order to maintain product shelf life.
How Is Quality Checked During Dry Syrup Manufacturing?
| Quality Test | Target Specification | Testing Equipment | Significance |
|---|---|---|---|
| Moisture Content | Below 1.5% w/w | Karl Fischer Titrator | Prevents powder caking & drug degradation |
| Assay & Potency | 98.0% to 102.0% | High-Performance Liquid Chromatography (HPLC) | Confirms correct active drug dosage per bottle |
| Reconstitution Time | Under 60 seconds | Visual Inspection & Timer | Provides smooth liquid suspension for pediatric patients |
| Particle Size Distribution | 40 to 80 Mesh Pass | Mechanical Sifter | Ensures consistent filling weight and flowability |
Visit Us At: F-109, 110, UPSIDC, Industrial Area, Central Hope Town, Selaqui, Dehradun
Why Choose Daffohils Laboratories for Dry Syrup Manufacturing?
Modern Certified Infrastructure
Daffohils Laboratories owns WHO-GMP and ISO 9001:2015 certified manufacturing facilities. In such a way, our production lines strictly comply with the national and international regulatory requirements, which ensures a perfect quality of pharmaceutical products.
Advanced Granulation Technology
We use automated fluid bed processors and rapid mixer granulators in our facility. As a result, the dry syrup manufacturing process provides dust-free and free-flowing granules that dissolve quickly without formation of insoluble clumps.
Rigorous Analytical Testing
The dedicated in-house laboratories conduct thorough chemical, physical, and microbiological testing of each batch. As a result, partners receive a full Certificate of Analysis (CoA) for each product before its market release.
Extensive Product Portfolio
Daffohils Laboratories manufactures a wide variety of dry suspensions, including beta-lactam, non-beta-lactam & pediatric antibiotic preparations. Additionally, we provide our services to third-party clients with flexible batch sizes starting from 5 thousand units.
Cost-Effective Scale Options
We provide competitive contract manufacturing prices starting from 15 rupees per bottle unit. As a result, pharma brands increase their commercial margins and receive premium packaging solutions, such as child-resistant caps and induction seals.
The Bottom Line
Knowledge of the dry syrup manufacturing steps can help pharmaceutical companies to select appropriate contract partners. Additionally, control over humidity, particle size, and moisture content provides a long shelf life of pediatric suspensions.
>Thus, cooperation with an industry leader, such as Daffohils Laboratories, ensures that your commercial brands receive the benefits of advanced WHO-GMP facilities, quick service, and high product safety. Optimize your dry syrup manufacturing process with Daffohils Laboratories and become the market leader in India.
Frequently Asked Questions
Q1. Why are dry syrups preferred over ready-to-use liquid suspensions?
Ans. Dry syrups prevent liquid hydrolysis of unstable antibiotics. Consequently, dry formulations become stable during storage and will activate only when the consumer adds purified water.
Q2. What relative humidity level is required in the filling area?
Ans. The filling area should have relative humidity below 40%. Low humidity prevents dry powders from absorbing ambient moisture and prevents clogging in filling machine nozzles.
Q3. How do binders improve the dry syrup formulation process?
Ans. Binders create granules from fine powder particles. In this way, the dry syrup formulation process improves the flowability of powders and avoids weight variation during automated packaging runs.
Q4. What is the shelf life of manufactured dry syrups?
Ans. Unopened dry syrup bottles have a shelf life of 24 to 36 months. Despite this, however, when reconstituted with water, the suspensions have to be used within 7 to 14 days.
Q5. Which packaging materials can provide the most protection for dry powders?
Ans. Manufacturers pack dry syrups in HDPE or amber glass bottles with aluminum induction foils. These prevent light rays and outside air from entering the packaging material.
Q6. How does fluid bed drying improve granule quality?
Ans. The fluid bed dryers involve the suspension of granules in the heated airflow, ensuring uniform heat transfer in the dry syrup manufacturing process. Consequently, the granules will dry uniformly without hot spots that lead to loss of strength of the active chemical.
Q7. What is the minimum batch size for contract manufacturing?
Ans. Most contract facilities accept a minimum order quantity of 5,000 to 10,000 bottles per batch. In this way, client brands optimize production and packaging costs.
Q8. What is the role of anti-caking agents in dry syrup formulations?
Ans. Colloidal Silicon Dioxide is used as an anti-caking agent that gives flowability to the powder in the dry syrup manufacturing process. This gives the dispersibility of dry syrup in water without any clumping.