ADM-SIO Pharmaceutical oils for Cannabinoid drug products.pdf

Refined Olive Oil is a pharmaceutical oil, suitable for use as API or excipient in human and veterinary applications in injectable, oral or topical dosage forms. It is obtained by refining of virgin olive oil, obtained by cold expression from the ripe fruit of Olea Europaea Linné, Refined Olive Oil fully complies with the European Pharmacopoeia monograph “Olive oil, refined”<1456> and USP-NF monograph “Olive Oil” including general chapters and is intended for use in the manufacture of parenteral preparations. Refined Olive Oil IV is manufactured under cGMP according to the ICH Q7 Good Manufacturing Practice (GMP) Guidance for APIs and regulatory supported with a certificate of suitability (CEP, No. R0-CEP 2015-167) and US DMF (type IV, # 034 152 & type II, # 035 559).

HIGH STABILITY GUARANTEE

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality Guideline show that Refined Olive Oil IV is perfectly stable over a 36-month shelf life period.


PACKAGING

ADM-SIO’s Refined Olive Oil IV is available in 56,5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.

Refined Soybean Oil is a pharmaceutical oil, suitable for use as API or excipient in human and veterinary applications in injectable, oral or topical dosage forms. It is obtained from seeds of Glycine max (L). Merr. (Glycine hispida (Moench) Maxim.) by extraction of crude soybean oil followed by a refining process. Refined Soybean Oil IV fully complies with the European Pharmacopoeia monograph “Soya-bean oil, refined”<1473> and USP-NF monograph “Soybean Oil” including general chapters and is intended for use in the manufacture of parenteral preparations. Refined Soybean Oil IV is manufactured under cGMP according to the ICH Q7 Good Manufacturing Practice (GMP) Guidance for APIs and is regulatory supported with a certificate of suitability (CEP, No. R1-CEP 2011-115) and US DMF (type IV, # 028 528 & type II, # 035 560).


HIGH STABILITY GUARANTEE

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality Guideline show that Refined Soybean Oil IV is perfectly stable over a 36-month shelf life period.


PACKAGING

ADM-SIO’s Refined Soybean Oil IV is available in 56,5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.

Refined Sesame Oil IV-1 is obtained from the seeds of one or more varieties of Sesamun indicum L. (Fam. Pedaliaceae) by expression followed by a refining process. Refined Sesame Oil IV-1 complies with the specifications of European Pharmacopoeia monograph “Sesame Oil, refined” <0433> and NF/US Pharmacopeia monograph “Sesame Oil”, intended for use in the manufacture of parenteral preparations. Strict selection, based on starting materials and product analysis, allows deliveries of homogen batches, in accordance with the Pharmaceutical GMP requirements. Supported with Drug Master File (DMF type IV, # 031 697) for excipients submitted to the U.S. Food and Drug Administration (FDA).


HIGH STABILITY GUARANTEE

Stability studies performed according to the International Conference on Harmonization (ICH) Q1A Quality Guideline show that Refined Sesame Oil IV-1 is perfectly stable over a 36-month shelf life period.


PACKAGING

ADM-SIO’s Refined Sesame Oil IV-1 is available in 56,5 Kg or 200 Kg tight-head metal drums that are filled under nitrogen in an ISO 8-classified cleanroom.

Our VGB 4S is a high melting point fully hydrogenated soybean oil presented in flakes.

It complies with the specifications of:European Pharmacopoeia “Soybean Oil,  hydrogenated” <1265> monographUSP/NF Pharmacopeia “Hydrogenated  Soybean Oil” monograph

 

Sesame seeds (Sesamum indicum L.) have been grown in tropical regions throughout the world since prehistoric times. It has been one of the fi rst crops processed for oil production.

Sesame oil has been used for healing wounds for thousands of years and is mentioned in the Vedas in India as is mentioned in the Vedas in India as ideally suited for the human species.

Nowadays it is used in food, nutraceutical, cosmetic and pharmaceutical industries.

Pharmaceutical ingredients play a key role in drug formulation. Variations in their composition and physicochemical properties can have significant impact on the final drug product performances like safety, physical and chemical stability and bioavailability. In the recent past, ingredient variability has been at the origin of FDA recalls.

Encapsulation relates to technologies that enable the incorporation of a compound into individualized small particles. Depending on the process applied, these particles can have different sizes, shapes and specific structures. Many kinds of active compounds can be encapsulated with many different encapsulation materials. High melting point solid vegetable oils are one of them.